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DGRA INTRANET |
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finden Sie interne Informationen für Mitglieder.
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GESCHÄFTSADRESSE: |
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Adenauerallee 15
D-53111 Bonn
Tel.: 0228 / 368264-6
Fax: 0228 / 368264-7
E-Mail: info@dgra.de
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| PRÜFUNGSARBEITEN / MASTER-THESIS |
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Die Zusammenfassungen der "Master-Thesis" der Studenten/innen des Studienganges "Master of Drug Regulatory Affairs" können hier nach einem Stichwort durchsucht werden.
Eine Übersicht und die Volltexte im PDF-Format der mit "sehr gut" bewerteten Master-Thesis finden Sie hier.
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| Die Zusammenfassungen der "Master-Thesis" der Studenten/innen des Studienganges "Master of Drug Regulatory Affairs" können alphabetisch nach Nachname des/der Studenten/in sortiert werden. |
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Dr. Roland Kröger (2003) |
| Pharmacovigilance Critical Assessment of Current Regulatory Issues with Special Regard to Urgent Safety Restrictions
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[Summary...] |
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Dr. Christian Krezdorn (2002) |
| Project Report on: Theory and Reality of Multiple Applications in National Procedure, MRP and CP Demonstrated by Practical Case Reports
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[Summary...] |
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Dr. Karin Heidenreich (2001) |
| Review 2001: The future of the Mutual Recognition Procedure including special aspects of the EU-enlargement
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[Summary...] |
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Dr. Christof Krummeich (2003) |
| Regulatory and pharmaceutical demands on irradiated medicinal products in Germany and Europe
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[Summary...] |
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Dr. Frank-Torsten Raschko (2002) |
| Access to unlicensed pharmaceuticals. An overview of the legal options for patients in Germany, France and the USA
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[Summary...] |
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Dr. Jens Schletter (2002) |
| Specific regulatory requirements for stem cell-based therapies
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[Summary...] |
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Dr. Elke Bertram-Neis (2001) |
| Orphan Drugs and rare diseases
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[Summary...] |
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Dr. André Dorochevsky (2011) |
| EMA's Product Information Management (PIM) project halted – Impact from the perspective of biotech companies on strategies for structured product information management
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Michaela Bleile-Röhrlich (2001) |
| Established active substances: Process of registration and regulatory strategy for submissions in the EU
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[Summary...] |
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Dr. Christine Bautz (2003) |
| The legal status of medicinal products: Potential problems arising in case of a compulsory harmonisation as discussed in the current revision of the EU legislation
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[Summary...] |
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Dr. Elmar Hermann Schmitt (2004) |
| Regulatory background in the development of medicinal products for human use produced by transgenic animals - current situation in the EU and USA
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Robert Alz (2003) |
| Antimicrobial Drug Resistance - Impact on the Pre- and Postlicensing Process of Veterinary Medicinal Products in the European Community
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[Summary...] |
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Dr. Beate Ackermann (2001) |
| The Internet presentation of national regulatory authorities in Europe and Japan
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[Summary...] |
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Dr. Michael Berntgen (2003) |
| Exploring Paediatric Indications for Off-patent Drug Substances - Strategic Input of Regulatory Affairs
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Christine Binninger (2004) |
| Regulatory standards on clinical trials for medical devices and medicinal products in case of orthopedically used hyaluronic acid
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[Summary...] |
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Dr. Ulrike Bodesheim (2002) |
| Review of the European variation regulation and the impact on changes in manufacturing and control of medicinal products
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[Summary...] |
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Lada Bogdanovic (2004) |
| Implications of the EU Clinical Trial Directive 2001/20/EC on the conduct of paediatric studies in Germany
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[Summary...] |
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Dr. Wolf-Rüdiger Schlag (2002) |
| Analytical validation of medicinal products in contract laboratories: From the task description to an SOP for the routine analysis - an overview
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[Summary...] |
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Dr. Isabel Schemainda (2003) |
| EU Enlargement on 1 May 2004: Implications on Existing Marketing Authorizations in the Candidate Countries: Practical Aspects
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[Summary...] |
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Kris Pelzer (2003) |
| Chemical-Pharmaceutical Documentation for Pressurised Metered Dose Inhalers
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[Summary...] |
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Brigitte Nerl (2001) |
| Maintenance of Generic Marketing Authorizations
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[Summary...] |
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Dr. Carolin Notheis (2001) |
| Regulatory requirements concerning the quality of herbal medicinal products under the EU pharmaceutical and national food legislation
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[Summary...] |
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Claudia Hettenkofer (2004) |
| Implementation of an internal Standard Operating Procedure for the Preparation of Mutual Recognition Variations
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[Summary...] |
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Uta Müller (2002) |
| Elektronische Einreichung von Zulassungsunterlagen - Stand und Möglichkeiten für die Zukunft
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[Summary...] |
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Dr. Ursula Moosbauer (2004) |
| The Impact of Stereoisomerism on the Regulation Procedure on the Example of Antibiotics
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[Summary...] |
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Peter Frank Eggen (2002) |
| The Regulation 21 CFR Part 11 and Aspects of Computer Systems Validation for Pharmaceutical Companies
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[Summary...] |
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Patricia Lüer (2002) |
| Alternative methods for animal testing in the drug regulatory environment
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[Summary...] |
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Rika Kremmer (2003) |
| Regulatory Enviroment for Traditional Herbal Medicinal Products in the European Union
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[Summary...] |
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Uta Kästner (2002) |
| Arzneimittelsicherheit Aut-idem eine Gratwanderung zwischen therapeutischem Anspruch und finanziellen Zwängen
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[Summary...] |
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Miriam Hoffmann (2002) |
| Advantages and disadvantages of the changes intended in the "Review 2001" with regard to Renewals of Marketing Authorisations and the impact on post-marketing surveillance
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[Summary...] |
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Birgit Haas-Heinrich (2002) |
| Critical assessment of the stability section of an Ibuprofen sample dossier: relevance from a scientific point of view
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[Summary...] |
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Dr. Daniel Gommel (2004) |
| Developments in Regulatory Pharmaceutical Toxicology:
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[Summary...] |
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Dr. Petra Heyen (2004) |
| Regulatory Intelligence as the basis for Regulatory Strategy and Global Drug Development
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[Summary...] |
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Dr. Joachim Heinze (2001) |
| Legal Basis of the Parallel Participation of the Principality of Lichtenstein in the European Economic Area and the Customs Union with Switzerland
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[Summary...] |
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Dr. Beate Hötzl (2003) |
| Biotechnological generics - a matter of science or science fiction?
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[Summary...] |
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Dr. Kirsten Hiebenthal-Millow (2003) |
| Test procedures in the specifications for herbal medicinal products according to CPMP / CVMP-guidelines compared with those for chemically defined medicinal products
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[Summary...] |
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Dr. Klaus Hohenleitner (5/2001) |
| "The quality of the active substance - A look at the different regulatory requirements "
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[Summary...] |
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Wolfram D. Hummel (2002) |
| Quality Management Systems (QMS) in the Context of Planning for and Controlling the Quality of Drugs
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[Summary...] |
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Dr. Alexander Kainz (2001) |
| Developing biopharmaceuticals - Regulatory aspects of the safety evaluation of monoclonal antibodies in the United States and in Europe
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[Summary...] |
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Claudia Koritke (2003) |
| Essential Aspects of Quality Assurance in Outsourcing Production and Purchase of Active Pharmaceutical Ingredients
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[Summary...] |
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Julia Tillkes (2003) |
| Limits of "Essential Similarity" regarding abridged marketing Authorizations
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[Summary...] |
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Maren Seip (2003) |
| Biopharmaceutics Classification System - State of the Art in Development and Practice
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[Summary...] |
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Beate Schmidt-Krauthause (2001) |
| Implementation of complaint management in a sales and distribution only company for pharmaceuticals
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[Summary...] |
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Dr. Thomas Lauterbach (2004) |
| Characterization of Impurities during Development of Chemically Synthesized Compounds Regulatory Requirements
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[Summary...] |
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Dr. Anja Mecklenburg (2003) |
| Strategies for Carcinogenicity Testing of Human Pharmaceuticals
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[Summary...] |
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Viraj Mehta (2004) |
| Trade Related Aspects of Intellectual Property Rights and Pharmaceuticals: The Impact of Extended Protection on India
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Hans-Jürgen Mika (2002) |
| GMP Relating to Medicinal Products - Quality Instrument or Regulatory Burden
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[Summary...] |
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Bettina Missner (2004) |
| National and International Information Exchange through Vigilance Reports
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[Summary...] |
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Birgit Moetamedi (2003) |
| Comparison and assessment of the current EU-Variation Regulations 541/95 and 542/95 and the revised new EU-Variation Regulations 1084/2003 and 1085/2003
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[Summary...] |
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Lena M. S. Perquy (2002) |
| CTD: Quality Overall Summary vs. Expert Report. Advantages and Disadvantages from the View of the Applicant and the Competent Authority
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[Summary...] |
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Erika Piest (2002) |
| Requirements for the presentation of data in Module 3 of the CTD for new drug products
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[Summary...] |
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Dr. Katrin Sauerland (2001) |
| The Demarcation of Medical Devices and Medicinal Products in the European Union
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[Summary...] |
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Nadine Schliecker (2003) |
| Challenges for the SmPC Harmonisation of Generics in Mutual Recognition
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[Summary...] |
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Dr. Cornelia Schmidt (2003) |
| Medicines for Children, a Regulatory Target!
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[Summary...] |
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Dr. Jürgen Hans Schmidt (2001) |
| From study protocol to final report -practical aspects and constructive input of the DRA/QA function in this process-
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[Summary...] |
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Dr. Diane Seimetz (2002) |
| Early Market Access - Regulatory Environment in the EU and the USA and Essential Requirements within the Pharmaceutical Company
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[Summary...] |
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Heike Strutzenberger (2004) |
| The regulatory requirements of EU-Directive 2001/20/EC and transposition into national legislation of the Member States
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[Summary...] |
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Frauke K. Stamm (2003) |
| The Revision of the European Regulation 2309/93 - Comparison and Assessment of the Draft Version and the Results of the First Reading of the European Parliament
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[Summary...] |
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Sandra Strohhöfer (2003) |
| Generic applications in the EU and in the USA - a comparison
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[Summary...] |
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Verena Stumpf (2004) |
| Switch from CFC-containing to CFC-free metered dose inhalers - current status and regulatory aspects
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[Summary...] |
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Yuhong Sun |
| Variation to marketing authorisations granted for medicinal products in Asia with focus on the Chemical Manufacturing and Control part based on the currently valid EU variation categories
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[Summary...] |
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Dr. Anja Tischlich (2002) |
| Regulatory and economic conditions for clinical trials in children
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[Summary...] |
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Dr. Adriana Ivanova Vladimirova (2003) |
| Development of generics during patent protection. Legal and regulatory framework in the EU and North America /USA and Canada/, consequence for the Candidate countries
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[Summary...] |
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Dr. Jan Richter (2004) |
| Scientific and regulatory concepts for the development of molecular targeted anti-cancer drugs
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[Summary...] |
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Dr. Doreen Gerlach (2004) |
| The "Arzneimittel-TSE-Verordnung" in Germany - Motives for this regulation and its consequences for medicinal products containing gelatine
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[Summary...] |
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Anja Hilse (2004) |
| Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing for blister packs
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[Summary...] |
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Dr. Beate Preuss (2004) |
| Quality related changes during the life-cycle of a medicinal product marketed in the EU and their impact on the pharmaceutical documentation (CTD module 3)
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[Summary...] |
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Michael Riesenberger (2003) |
| Legal and regulatory aspects of manufacturing, quality control and release of 2-[18F]Fluro-2-desoxyglucose ([18F]-FDG) as an example for short-lived radiopharmaceuticals in reflection of relevant regulations, directives and guidelines
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[Summary...] |
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Dr. Wolfgang Meyer (2005) |
| Preclinical and clinical development of anticancer drugs - regulatory peculiarities
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[Summary...] |
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Dr. Karen Rosenkranz (2005) |
| Regulatory strategies for life-cycle management of chemical defined cytostatic drugs with regard to the new pharmaceutical legislation
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[Summary...] [Volltext als PDF-Datei...] |
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Ute Ukelis (2005) |
| Replacement of In Vivo ATC Studies by In Vitro Cytotoxicity Methods
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[Summary...] |
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Sandra Strobl (2002) |
| Variation applications within the European Community for a) innovative medicinal products authorised by centralised procedure, b) new medicinal products authorised by mutual recognition procedure
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Doris Wolf (2005) |
| Safety reporting in clinical trials
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[Summary...] |
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Dr. Daniela Lieder (2005) |
| Evaluation and consideration of resistance data on the licensing process of antibiotics
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[Summary...] |
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Ingrid Schulz (2005) |
| Comparison of CMC requirements for Clinical Trials in the US and the European Union
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[Summary...] |
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Andrea Hörner (2005) |
| Describe the CADREAC-procedure for a product which was authorized via mutual recognition procedure in the EU and ...
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Barbara Blumbach (2005) |
| Comparison of the regulatory environment for herbal medicinal products in the three ICH regions: EU, US and Japan
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[Summary...] |
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Dr. Andrea Klüting (2005) |
| The Effects of the 12th Amendment to the German Pharmaceuticals Act on Clinical Trials in Academic Institutions and the Pharmaceutical Industry
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[Summary...] [Volltext als PDF-Datei...] |
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Stefanie Lemke (2005) |
| Changes in the Field of Pharmacovigilance within the Scope of the 12th amendment and the drafted 14th amendment of the German Drug Law and the related EU legislation
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Michael Klimars (2005) |
| Global Requirements for Stability Testing – Are they Realistic for All Climatic Zones? – A Critical Evaluation
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[Summary...] |
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Dr. Boris Mey (2005) |
| Marketing authorisation of medicinal products used to prevent the toxicity of chemical, biological, radiological or nuclear substances (MA of Anti-CBRN Drugs)
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[Summary...] |
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Timea Janosi (2005) |
| Parametric release of sterility of parenteral medicinal products
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[Summary...] |
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Anja Kirsten Schiefer (2004) |
| Comparison of the requirements in the registration and marketing authorisation procedure of human homoeopathic medicinal products within the EU with regard to specific requirements in Germany, Austria, the Netherlands and Switzerland as a Non-EU-country
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Susanne Gluding (2005) |
| Chemical and Toxicological Qualification of Plastic Packaging Materials for Sterile Solutions
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[Summary...] |
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Katrin Dürr (2005) |
| Comparison of marketing authorisations procedures for biotechnological products in the European Union and in Switzerland
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[Summary...] |
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Dr. Rudolf Gmeinbauer (2005) |
| Decentralised Procedure, Mutual Recognition Procedure and Readability of SPC, PL, Labelling
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[Summary...] |
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Dr. Marion Heinzkill (2005) |
| Marketing Authorisation Procedures under the New Medicines Legislation – Impact on the Pharmaceutical Research Industry and Strategic Aspects
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[Summary...] [Volltext als PDF-Datei...] |
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Stefanie Abt (2005) |
| Generic applications after implementation of the new EU pharmaceutical legislation: Criteria for the choice of the Marketing Authorisation Procedure
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[Summary...] |
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Josefine Bauer (2005) |
| Plasma Master File - A Concept for Plasma-derived Medicinal Products
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[Summary...] |
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Dr. Manfred Kurz (2006) |
| Registration of antibody based medicinal products
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[Summary...] |
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Dr. Eva-Maria Möllenhoff (2005) |
| Requirements for active pharmaceutical ingredients in marketing authorization applications
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[Summary...] |
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Kristina Mumber (2006) |
| Regulatory Environment for medicinal products in Russian Federation
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[Summary...] |
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Dr. Folker Spitzenberger (2006) |
| Vigilance experience for high risk in vitro diagnostics: Risk assessment by the German competent authority and possible implications for the parties involved in the European medical devices system
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Sibylle Kaiser (2006) |
| Tissue engineered products – Need and requirements for an appropriate harmonised EU regulatory framework
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[Summary...] [Volltext als PDF-Datei...] |
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Claudia Hahne (2006) |
| Angemessenheit der Regelungen zum Vertrieb von Medizinprodukten
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[Summary...] |
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Dr. Markus Beßeling (2006) |
| European decentralised procedures for marketing authorisation –Differences and similarities between applications of veterinary and human medicinal products
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[Summary...] |
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Dr. Tatyana Benisheva-Dimitrova (2006) |
| Challenges For The Pharmaceutical Legislative Implementation In Terms Of An Accelerated Market Access After October 2005
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[Summary...] [Volltext als PDF-Datei...] |
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Ellen Güttler (2006) |
| Extended Role of Scientific Advice as a Consequence of the New Medicines Legislation in the EU including a Comparison to the Situation in the USA
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[Summary...] [Volltext als PDF-Datei...] |
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Gabriele Schäfer (2006) |
| Regulatory assessment of registration processes for biosimilar products- Conditions to be fulfilled to use special registration procedures designed by different decision matrices
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[Summary...] |
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Dr. Markus Hartmann (2005) |
| Impact of the new legislative framework within the European Union on non-commercial clinical research and investigator-initiated trials: a cross-European analysis with focus on oncology
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Hans-Joachim Gamperl (2006) |
| Drug Risk Management from an Industry Perspective - a Task for the Life Time of a Medicinal Product
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[Summary...] |
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Anette Keiser (2006) |
| Preparation of a check list to perform GMP-Audits of contract manufacturers following relevant provisions of law.
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[Summary...] |
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Thurid Buch geb. Fassbender (2006) |
| The (European) Public Assessment Report as an extended part of the European application procedure - Regulatory background and practical considerations
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[Summary...] |
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Renzo Wolbold (2006) |
| The regulatory environment and requirements for biological and biotechnology-derived medicinal products in Japan
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[Summary...] |
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Dr. med. vet. Flurina Stucki (2006) |
| New approaches and requirements in the registration procedure of MUMS-veterinary medicinal products. A comparison between USA, EU and Switzerland
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[Summary...] |
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Anette Wiesemann-Fuhr (2001) |
| Compare the FDA, EMEA and BfArM internet publication policy especially on approval, pharmacovigilance and Drugs on the horizon
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Anne Louise Kirkegaard (2006) |
| Strategic ordination of the regulatory instruments for obtaining early market access in the EEA, USA and Canada of a novel anticancer drug
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Ursula Bonsmann (2006) |
| Biowaivers Based on the BCS – Only for Class I ?
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[Summary...] |
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Dr. Cortina Kaletta (2006) |
| Overview of the Regulatory Environment for Developing New Vaccines Including the Specific Smallpox Vaccine and Pandemic Influenza Virus Vaccines
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Astrid Weyermann (2006) |
| Labelling requirements for investigational medicinal products in multinational studies: bureaucratic cost driver or added value?
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Susanne Donat (2001) |
| Mechanistic considerations on the carcinogenic effects of fibrates
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Susanne Kästner (2000) |
| Review 2000 – Review of Regulatory Procedure by the European Commission
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Dr. Angelika Koch (2006) |
| Möglichkeiten und Grenzen der Vermarktung von pflanzlichen Produkten
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[Summary...] |
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Dr. Christine Ernst (2000) |
| Realisation der Wahrnehmung der Aufgaben des Informationsbeauftragten in einem Vertriebsunternehmen unter Berücksichtigung der Abgrenzung der Aufgabenbereiche des Vertriebsleiters sowie der Schnittstellendefinition mit einem Lizenzgeber und Implementierung in das QS-System
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Dr. Tatjana Reinholz (2007) |
| Life cycle management of a marketed medicinal product in view of GMP and regulatory requirements and impact of Product Quality Reviews
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[Summary...] |
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Dr. Ursula Protin (2007) |
| First experiences with Conditional Marketing Authorisations in the EU: requirements, obligations, initial experiences and perspectives
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[Summary...] [Volltext als PDF-Datei...] |
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Yuwei Heinzel (2007) |
| Regulatory Impact of the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00) on the Pharmaceutical Development
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[Summary...] |
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Ellen Frey-Stanislawski (2007) |
| Revision of the Variation Regulations Commission Regulation (EC) No. 1084/2003 and No. 1085/2003 - Industry-Proposals and Consultation Paper from the European Commission, Impact on Industry and Health Authorities
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[Summary...] [Volltext als PDF-Datei...] |
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Ariane Prochaska (2007) |
| Assignment of GMP data within application dossiers and during external inspections
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[Summary...] |
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Dr. Frank Jeblonski (2007) |
| New developments in European registration procedures and requirements, in particular consideration of biological/biotechnological-derived medicinal products
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[Summary...] |
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Dr. Dagmar Theis (2007) |
| Legal Framework for Compassionate Use in the European Union - Comparison of the Implementation of Compassionate Use Programmes by Means of Selected European Member States
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[Summary...] |
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Tanja Weber (2007) |
| A Step Beyond Module 3 of Biodegradable Implants
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[Summary...] |
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Elvira Holder (2007) |
| Comparison of the requirements for simplified registration and marketing authorization procedure of homeopathic products with Austria, France, Germany, Italy and Switzerland
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[Summary...] |
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Lena Gebert (2007) |
| Impfstoffe für den Menschen - Ein Leitfaden über die besonderen arzneimittelrechtlichen Regelungen aus dem Arzneimittelgesetz
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[Summary...] [Volltext als PDF-Datei...] |
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Wiebke Hoppensack (2007) |
| Triggers for Regulatory Changes – Implication of the TGN1412 incident on regulatory requirements for first-in-man trials
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[Summary...] |
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Dr. Ursula Schickel (2007) |
| The impact of the revised EU-legislation concerning particular needs of blind and partially-sighted patients and user testing – a challenge for pharmaceutical companies with focus on Germany
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[Summary...] [Volltext als PDF-Datei...] |
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Martin Watzl (2007) |
| The New Paediatric Regulation in the EU – Development, Implications and Comparison with US Experiences in Paediatric Drug Development
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[Summary...] [Volltext als PDF-Datei...] |
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Wieland Peschel (2007) |
| The regulatory challenge to improve the safety of Traditional Herbal Medicinal Products in Europe
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[Summary...] |
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Angelika Ommeln (2007) |
| Regulatory Data Analysis for the development of a database for country specific requirements
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[Summary...] |
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Dr. Ulrich Fritsche (2007) |
| An Overview of the Regulatory Framework of Fixed Dose Combination Medicinal Products (FDC)
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[Summary...] |
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Dr. Stefan Zwilling (2007) |
| Monoclonal antibodies developed as anticancer drugs: EU clinical trial application with focus on IMPD requirements
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[Summary...] [Volltext als PDF-Datei...] |
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Seval Tangut (2007) |
| New Regulatory Environment in Turkey
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[Summary...] |
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Dr. Michael Bernhard (2007) |
| Quality attributes of biopharmaceuticals: The impact of glycosylation
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[Summary...] |
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Anja Karstens (2007) |
| Differences between EU and US registration requirements for sterile human and veterinary products (quality part) for: a) First filing b) CMC changes
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[Summary...] |
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Dr. Silvia Sanner (2007) |
| Registration Procedures in South Africa
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[Summary...] |
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Michaela Krause (2007) |
| ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System: vision, concept and their potential impact on industry and regulators – will they foster innovation?
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[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Peter Satter (2007) |
| Assessment of potential similarity between orphan drugs
|
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[Summary...] |
| |
|
Jörg Cselovszky (2007) |
| The New Regulatory Framework for Health Claims in the Eurpean Union – Impact on the Demarcation of Food to Medicinal Products?
|
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[Summary...] |
| |
|
Elke Gurschke (2011) |
| Best Practice Guide for Regulatory Affairs in a German CRO - From Application to Clinical Trial Report: Implications of Well-Structured Completion of Relevant Steps
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Tünde Molnár (2007) |
| Generics Medicines in the Centralised Procedure
|
|
[Summary...] |
| |
|
Dr. Desi W. Soegiarto (2007) |
| Changes of Pharmacovigilance Requirements within the Scope of Volume 9A and Related EU Guidelines
|
|
[Summary...] |
| |
|
Dr. Matthias Hübner (2012) |
| Worldwide Regulatory Strategy for the Development and Submission of a Recombinant Product antagonizing the Action of a Medicinal Product
|
|
[Summary...] |
| |
|
Dr. Ludger Benning (2007) |
| Electronic Submission and the MRP/DCP: How to Compile a Dossier That Will be Accepted at the European Agencies
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Tong Zhang (2007) |
| Audit Check List for Sterile Active Pharmaceutical Ingredients
|
|
[Summary...] |
| |
|
Dr. Michael Walser (2007) |
| Analytical Method Validation: Compilation of Relevant Legislation, Guidelines, and Literature
|
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[Summary...] |
| |
|
Dr. Sabine Schmitz (2007) |
| Pharmaceutical Excipients – Regulatory and GMP Requirements
|
|
[Summary...] |
| |
|
Anneke Hackling (2007) |
| Clinical Trials in China
|
|
[Summary...] |
| |
|
Dr. Dirk Schmidt (2007) |
| Impact and Consequences of the PAT Initiatives by FDA and EMEA on New Chemical Entity Synthesis
|
|
[Summary...] |
| |
|
Carola Seidel (2008) |
| Das IQWiG als neuer Eckpfeiler bei der Entscheidungsfindung des Portfolios der Generikaunternehmen
|
|
[Summary...] |
| |
|
Dr. Monika Hitzl (2008) |
| Global regulatory requirements and how to reflect them in the process control system of pharmaceutical industry - Implementation of Process Analytical Technology
|
|
[Summary...] |
| |
|
Dr. Martin Wendland (2008) |
| Regulatory guidance on comparability studies for biological products following changes to the manufacturing process and analytical procedures
|
|
[Summary...] |
| |
|
Kristina Tripp (2011) |
| Case Study: Impact of a new German law ("AMNOG") to restructure the pharmaceutical market on a Generic Company
|
|
[Summary...] |
| |
|
Dr. Kirsten Jacobs (2011) |
| Regulatory Requirements for medical devices in major countries of Latin America
|
|
[Summary...] |
| |
|
Sophie Breitenfeld, geb. Brenner (2011) |
| Central Registration in the Gulf Countries – An Opportunity for Global Companies?
|
|
[Summary...] |
| |
|
Dr. Franz Thannberger (2011) |
| A Step beyond Module 3 of "passive" Transdermal Therapeutic Systems
|
|
[Summary...] |
| |
|
Antje Ebermaier (2011) |
| Continuous update of antimicrobial resistance data of purely nationally authorised antibiotics for human use in Germany - a challenge for European registrations
|
|
[Summary...] |
| |
|
Dr. Henning Brohmann (2011) |
| Genotoxicity in mammalian cell assays in vitro: necessity to revise current pharmaceutical regulations?
|
|
[Summary...] |
| |
|
Dr. Astrid Kaufmann (2008) |
| Is ‘Readability Testing’ an adequate procedure to improve the legibility of package leaflets? A European comparison including German and British liability aspects
|
|
[Summary...] |
| |
|
Dr. Bettina Walter-Lorenzen (2011) |
| Improvement of the workflow, quality and effective management of product information texts using a new database
|
|
[Summary...] |
| |
|
Sandra Schneidereit (geb. Nehlsen) (2008) |
| The Escitalopram Case: A Comprehensive Strategy Allowing for Early Market Access of a Generic Drug
|
|
|
| |
|
Dr. Karin Markgraf (2008) |
| Biosimilars in the EU and in the US
|
|
[Summary...] |
| |
|
Dr. Christian Kutzleb (2008) |
| Comparison of the Regulatory Environment to Authorise so-called Combination Products Consisting of a Drug and a Medical Device in the US and the EU
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Christine Gillen (2008) |
| Could the Global Harmonization Task Force guidance of a standardized harmonized documentation format succeed in global harmonization?
|
|
[Summary...] |
| |
|
N´djamawè Bah-Traore (2008) |
| Drug Safety and Counterfeit Medicines
|
|
[Summary...] |
| |
|
Dr. Ursula Beikert (geb. Tammler) (2008) |
| REACH – How does it affect the pharmaceutical industry? Consideration of the issue for a medium-sized enterprise
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Beatrix Metzner (2008) |
| Comparison of marketing authorization procedures for biotechnological products in the European Union (centralized procedure) and in Japan (J-NDA)
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Britta Neubauer (2008) |
| CMC Documentation Contemplation on regulatory requirements in relation to the maintenance of drug products concerning life cycle and change management
|
|
[Summary...] |
| |
|
Florian Strohmaier (2008) |
| Evaluation of the legal basis of biological and biotechnological product applications in Europe and US and discussion of consequences for similar biological medicinal product applications
|
|
[Summary...] |
| |
|
Heli Hulkkonen (2008) |
| Generic Medicinal Products – A Comparison of Regulatory Framework between Germany and Finland
|
|
[Summary...] |
| |
|
Dr. Matthias Dormeyer (2008) |
| Regulatory Strategies and Practical Aspects for the Development and Authorisation of Orphan Medicinal Products in the European Union
|
|
[Summary...] |
| |
|
Mariela Becker (2008) |
| Experiences with the New Decentralised Procedure – Changes, Limits, Perspectives
|
|
[Summary...] |
| |
|
Ines Becker-Schnoor (2008) |
| Sunset Clause- Implementation within the EU and its influence on regulatory strategies
|
|
[Summary...] |
| |
|
Kirsten Martin (2007) |
| Readability User Testing of package leaflets: Regulatory requirements, methodologies and assessment
|
|
[Summary...] |
| |
|
Dr. Theodore L. Drell IV (2008) |
| Defining the regulatory strategy for the rapid implementation of a multinational, global clinical trial in an oncological indication
|
|
[Summary...] |
| |
|
Bettina Geng (2008) |
| "Die Nachzulassung" – Legal requirements and regulations regarding the pharmaceutical quality of medicinal products from the notification of 1978 until today
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Jana Nissen (2012) |
| Prostaglandin analogues as lash enhancers – cosmetics or medicinal products?
|
|
[Summary...] |
| |
|
Dr. Sanjiv Verma (2008) |
| The Regulatory Framework concerning the Import of Medicinal Products in India and in the European Union (e.g. Germany)
|
|
[Summary...] |
| |
|
Susanne Igl (2008) |
| Quality of Medical Devices Incorporating a Medicinal Substance Having Ancillary Action in the EU – Requirements According to Medical Device Regulations and According to Medicinal Products Regulations
|
|
[Summary...] |
| |
|
Dr. Tatiana Reimer (2008) |
| Impact of scientific advice on the outcome of marketing authorisation applications submitted to the CHMP between 2004 and 2007
|
|
[Summary...] |
| |
|
Dr. Bianca Krafft (2007) |
| Scientific Advice - Value Adding Strategies for Regulatory Agencies and Pharmaceutical Companies
|
|
[Summary...] |
| |
|
Dr. Andreas Grummann (2008) |
| Strengthening and Rationalising the European Pharmacovigilance System
|
|
[Summary...] |
| |
|
Stephanie Pick (2008) |
| Die Packungsbeilage als Instrument der Verbraucherinformation im Wandel der Zeit
|
|
[Summary...] |
| |
|
Dr. Roger Müller-Pfaff (2006) |
| Einführung des Hämaphereseverfahrens in den Blutspendedienst der Bundeswehr
|
|
|
| |
|
Dr. Patricia Stöhr (2008) |
| The Regulatory Environment for Vaccine Development - a Challenge for Industry
|
|
|
| |
|
Dr. Thorsten Henning (2009) |
| Rx-to-OTC switch – Comparison of the Current Regulatory Approaches in Germany, in the UK, and in the USA
|
|
[Summary...] |
| |
|
Saskia Kissel (2008) |
| Gibt es eine Zukunft für die Standardzulassung in Deutschland?
|
|
[Summary...] |
| |
|
Dr. Janina Julia Bielefeldt (2008) |
| Evaluierung der deutschen und europäischen Rechtsprechung hinsichtlich des Risikos für Arzneimittelfälschungen
|
|
[Summary...] |
| |
|
Dr. Uta Maucher (2009) |
| Product Quality Review: New requirements related to medicinal products
|
|
[Summary...] |
| |
|
Dr. Ulrich Feil (2009) |
| Replacement, Reduction, Refinement of Animal Testing in Quality Control of Medicinal Products in the EU
|
|
[Summary...] |
| |
|
Dr. Olaf Stamm (2009) |
| Pathogen safety concepts for Biopharmaceuticals
|
|
[Summary...] |
| |
|
Dr. Detelina Ivanova (2009) |
| PDCO – one year experience of the paediatric regulation
|
|
[Summary...] |
| |
|
Dr. Claus-Peter Danzer (2009) |
| Borderline Situations and other important Aspects for the Regulatory Work with Medicinal Products for Oral Care in Europe
|
|
[Summary...] |
| |
|
Rainer Brunschier (2008) |
| Generic Drug Submissions in Japan from a Global Player’s Point of View
|
|
[Summary...] |
| |
|
Dr. Werner Schmidt (2009) |
| Legal Status of Donor-Lymphocyte Infusions manufactured by transiently activated Memory T cells in the context of the European Regulatory Framework
|
|
[Summary...] |
| |
|
Michael Hahn (2009) |
| Die Auswirkungen der Arzneimittelrabattverträge nach dem GKV-Wettbewerbsstärkungsgesetz auf den deutschen Generikamarkt
|
|
[Summary...] |
| |
|
Edith Ueberschaer (2009) |
| Regulatory Requirements for Electronic Expedited Reporting in the European and in the German Legislation with Examples to their Implementation in a Pharmaceutical Company
|
|
[Summary...] |
| |
|
Dr. Kim Wuthold (2009) |
| Regulatory requirements of the quality of traditional herbal medicinal products and the resulting challenge for the pharmaceutical industry
|
|
[Summary...] |
| |
|
Josephine Stiebler (2009) |
| Maintaining compliance with GRP while changing the business process aiming to be able to submit new applications in electronic format (eCTD, paperless) appropriately by end of 2009
|
|
|
| |
|
Dr. Maria Teresa Piccini (2009) |
| FDA programs to expedite innovative drug development and review process: Fast Track, Priority Review and Accelerated Approval
|
|
[Summary...] |
| |
|
Dr. Ulrich Reichert (2009) |
| Implementing the Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents (EMEA/CHMP/SWP/4446/2000)
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Christine Kriete (2009) |
Peculiarities and Challenges of Herbal Medicinal Products -
Assessment of Herbal Medicinal Products within the Regulatory Environments of the European Community and the United States
|
|
[Summary...] |
| |
|
Dr. Zoran Pavlovski (2007) |
| Essential regulatory requirements in the United States related to medical devices intended for human use
|
|
[Summary...] |
| |
|
Dr. Benita von Glahn (2008) |
| Post marketing Activities in Japan compared to EU and USA
|
|
[Summary...] |
| |
|
Andrea Schorr (2002) |
| Bracketing and Matrixing: Discussion of the regulatory requirements from a scientific point of view and drawing up of a sample testing plan for a combined bracketing/matrixing design. Where is the justifiable limit for a reduction?
|
|
|
| |
|
Dr. Sabine Drechsler (2006) |
| The re-evaluation regulatory assessment procedure for old herbal medicinal products in Germany, focussing on clinical aspects
|
|
[Summary...] |
| |
|
Sylvaine Hartmann (2006) |
| Change Control and Variations in Chemistry – Consequences on the regulatory workload for Active Substance Manufacturers
|
|
[Summary...] |
| |
|
Dr. Christina Veiel-Fietzek (2009) |
| Addition of a manufacturing site for a sterile medicinal product (lyophilisate) - Points to consider for transfer of manufacturing process to a contract manufacturer and impact of changes with regard to the registration dossier in the light of the current variation procedure
|
|
[Summary...] |
| |
|
Dr. Rüdiger Vallon (2009) |
| Regulatory framework for advanced therapy medicinal products (ATMPs) according to the Regulation (EC) No 1394/2007
|
|
[Summary...] |
| |
|
Dr. Susanne Manhart (2009) |
| Development of a New Active Substance for Treatment of Alzheimer’s Disease – Development from Preclinical Testing to Proof-of-Concept
|
|
[Summary...] |
| |
|
Angela Röder (2009) |
| Impact of the genotoxic requirements on the generic industry
|
|
[Summary...] |
| |
|
Dr. Nicole Max (2009) |
| Legal proposal to allow pharmaceutical companies to provide information to patients on prescription-only medicines – a controversial discussion
|
|
[Summary...] |
| |
|
Claudia Keupp (2009) |
| Portfolio strategies of cytotoxic drugs – current topics of regulatory economy
|
|
[Summary...] |
| |
|
Dr. Christa Pfleiderer (2009) |
| Regulatory Requirements for Pharmaceuticals, Biotechnological Products, and Biosimilars in Latin America: Common Requirements and Differences
|
|
[Summary...] |
| |
|
Viola Hieble-Gerhard (2009) |
| Risk-based management of GMP audits within the context of supplier relationships – an approach for a medium-sized pharmaceutical company
|
|
[Summary...] |
| |
|
Dr. Karolina Zientek-Lang (2009) |
| Procedures following the Centralised, Mutual Recognition and Decentralised Procedure in case of a negative outcome of the assessment of the marketing authorisation application. Function of the CHMP and the CMD(h)
|
|
[Summary...] |
| |
|
Dr. Susanne Lange (2009) |
| The new Variation Regulation. A major step forward?
|
|
[Summary...] |
| |
|
Houmyra Kazimie (2009) |
| European and national (German) databases with regard to clinical trials involving children
|
|
[Summary...] |
| |
|
Becker, Stephan (2009) |
| Regulatory Considerations on Drug Interaction Studies
|
|
[Summary...] |
| |
|
Dr. Susanne Vambrie (2009) |
| Regulatory Requirements for the Clinical Development of New Therapies for the Treatment of Alzheimer’s Disease
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Jiqing Madeleine-Wang (2004) |
| A Comparison of Generic Submission in Europe and in Asian Countries
|
|
|
| |
|
Gudrun Pfeffer (2010) |
| Biologics in Emerging Markets – Regulatory Strategy and Requirements
|
|
[Summary...] |
| |
|
Dr. Dietmar Theisen (2010) |
| European Regulatory Framework of Stem Cell-based Medicinal Products
|
|
|
| |
|
Frank Pietsch (2010) |
| Clinical Trials with Pharmaceuticals for Human Use - Ethical and Regulatory Aspects, Future Challenges
|
|
[Summary...] |
| |
|
Oliver Klaas (2008) |
| Process validation of a medicinal product: Compilation of relevant legislative, guidelines and literature
|
|
[Summary...] |
| |
|
Dr. med. Maria Ida Behrens (2010) |
| Chances for children with rare diseases under the Regulation EC 1901/2006
|
|
[Summary...] |
| |
|
Sigrun Adrian (2010) |
| Die Entwicklung unterschiedlicher Rechtsvorschriften und deren Überwachung im Bereich der Sicherheit von Arzneimitteln und Medizinprodukten in Deutschland (Pharmako- und Medizinproduktevigilanz)
|
|
[Summary...] |
| |
|
Annette Kiesewetter (2010) |
| The Declaration of Helsinki and its Revisions – A Mirror of the History of Ethical and Social Debates in Clinical Research
|
|
[Summary...] |
| |
|
Dr. Anna Silke Limpert (2010) |
| Quality of Allergen Products for Specific Immunotherapy - A Guidance for Industry for Compilation of Module 3 for the EU CTD (Quality) Considering the German Therapy - Allergen Ordinance, the revised European Pharmacopoeia Monograph on Allergen Products (2010:1063) and the new "Guideline on Allergen Products - Production and Quality Issues" (EMEA/CHMP/BWP/304821/2007)
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Martin Knieps (2010) |
| Regulatory and Practical Risk Management of Potential Drug-Drug Interactions
|
|
[Summary...] |
| |
|
Hanna Bölke (2010) |
| Harmonisation of Product Information Texts of Generic Medicinal Products in EU – And its Impact on the Necessity of User Testing and Bridging
|
|
[Summary...] |
| |
|
Dr. Marko Kaulich (2010) |
| Change Control Systems in Europe – how are they influenced by Regulation EC1234/2008 and Directive 2009/53?
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Frank Michaelsen (2010) |
| Changes to clinical reporting requirements within the scope of title VII of the FDA Amendment ACT (FDAAA): An Industry Perspective
|
|
[Summary...] |
| |
|
Dagmar Hintz (2010) |
| System regulating Medical Devices for Use in Animals
|
|
[Summary...] |
| |
|
Jessica Luppus (2010) |
| National Requirements on Direct to Healthcare Professional Communication in the European Economic Area
|
|
[Summary...] |
| |
|
Santy Kerb (2010) |
| Application of Company Core Data Sheet (CCDS) in globally established medicinal products to ensure the accuracy of product information across international markets
|
|
[Summary...] |
| |
|
Monika Jung (2010) |
| Legal uncertainties in European Community legislation regarding data protection
|
|
[Summary...] |
| |
|
Syed Irshad Rizvi (2010) |
| Influenza A (H1N1)--a new communicable disease Role and activities of the Health Authorities and International Organizations in relation to the current H1N1 influenza pandemic
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Ridwan Sarwin (2010) |
| Assessment of the new EU variation regulation No 1234/2008/EC on the practicality aspects for post-approval changes of human medicinal products
|
|
[Summary...] |
| |
|
Michael Zlottchenko (2010) |
| The Quality and Safety Requirements for Vaccines with Emphasis on Viral Vaccines from a Global Point of View
|
|
[Summary...] |
| |
|
Dr. Carsten Kratzsch (2010) |
| On the Development and Application for Marketing Authorizations for Antidotes for the Treatment of Intoxications with Organophosphates and Nerve Agents
|
|
[Summary...] |
| |
|
Dr. Dieter Brazel (2010) |
| Regulatory Life Cycle Management of Plasma Protein Therapeutics
|
|
[Summary...] |
| |
|
Dr. Jasmin Fahnenstich (2010) |
| Prescription of Cannabis - Regulatory environment and current situation in Germany in comparison with the Netherlands and the USA
|
|
[Summary...] |
| |
|
Lars P. Frohn (2010) |
| Measures for industry, government and public authorities in Europe in the combat against counterfeit medicines. What is being done and what can yet be done.
|
|
[Summary...] |
| |
|
Dr. Frank Förster (2011) |
| Development of Alternative Carcinogenicity Test Methods in the Pharmaceutical Industry: Evaluation of the Current Validation/Application Status
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Andrea Krause (2010) |
| How to achieve and maintain compliance for quality documents in a global company
|
|
[Summary...] |
| |
|
Dr. Erik Schneider (2010) |
| Determination and comparison of the regulatory requirements of human recombinant antibodies, Fab-fragments and aptamers regarding product and manufacturing quality
|
|
[Summary...] |
| |
|
Dr. Stephanie Schwarz (2010) |
| Make off-patent drugs available to children: Regulatory approaches in Europe and the US
|
|
[Summary...] |
| |
|
Dr. Karl Zimmermann (2010) |
| Die gewerblichen Schutzrechte bei Arzneimitteln in der Europäischen Union und den USA – Arzneimittel und Patente
|
|
[Summary...] |
| |
|
Dr. Maren Ulrike Koban (2010) |
| Impact of Health Technology Assessment (reimbursement) on considerations for international regulatory strategies
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Wiebke Gesine Kamp (2010) |
| Application for Marketing Authorisation for a Generic Medicinal Product in Europe, USA and South Korea. Development of a Regulatory Strategy considering the different Regulatory Requirements.
|
|
[Summary...] |
| |
|
Victoria Naumann (2010) |
| Regulatory Text Mining in the field of Centralised Procedures for Human Medicinal Products
|
|
[Summary...] |
| |
|
Romuald Braun (2010) |
| White Spots in Document Management in the Life Sciences Industry
|
|
[Summary...] |
| |
|
Natascha Nickelt (2011) |
| Regulatory Assessment of Nanotechnology in Different Areas of Application -an Example of Regulating Emerging Sciences
|
|
[Summary...] |
| |
|
Anne-Kathrin Heese (2010) |
| Submission of variations to implement changes in the product information texts following European Paediatric Work Sharing Procedures according to Article 45/46 of Regulation (EC) No 1901/2006 - from the point of view of a generic company
|
|
[Summary...] |
| |
|
Dr. Claudia Karin Wagner (2010) |
| Distribution restrictions (Re-switch of OTC medicines) in Germany and in other selected countries
|
|
[Summary...] |
| |
|
Dr. Wolfgang Meder (2004) |
| Rx-to-OTC Switch - Opportunities And Risks With Focus On Statins
|
|
[Summary...] |
| |
|
Dr. Dorith Stauch-Steffens (2002) |
| Regulatory Requirements concerning Development Pharmaceutics and Manufacturing of a Medicinal Product: A Critical Analysis from Pharmaceutical Technological View
|
|
[Summary...] |
| |
|
Dr. Ulrike Domack (2004) |
| Regulatory Science on Orphan Drug Application within Paediatric Field
|
|
[Summary...] |
| |
|
Dr. Ulrike Greger (2004) |
| Kritische Bewertung von Arzneimittel-Re-/Parallelimporten in Deutschland
|
|
[Summary...] |
| |
|
Monika Merfels (2004) |
| The new regulatory framework for authorisation and reevaluation of feed additives by the European Food Safety Authority in the European Union
|
|
[Summary...] |
| |
|
Dr. Katrin Mayer (2006) |
| Maintenance / life cycle management of a MRP-product – A case study
|
|
[Summary...] |
| |
|
Dr. Christina Pering (2006) |
| „Regulatory framework for the marketing authorisation of medicinal products for human use containing or consisting of genetically modified organisms – comparison of requirements in Europe and the United States“
|
|
[Summary...] |
| |
|
Claudia Lydia Abel (2001) |
| Haemophilia Conventional Therapy and Gene Therapy related to EU-Guidelines
|
|
|
| |
|
Doris Göllner (2002) |
| The organisation of a mutual recognition procedure by a pharma consulting company with Germany as RMS and all other EU member states including Norway and Iceland as CMS - experience and suggestions for practical implementation
|
|
|
| |
|
Dr. Barbara Römer (2008) |
| 2001/20/EC - A European Directive? Major Regulatory Objectives for a real Harmonisation in Europe
|
|
[Summary...] |
| |
|
Dr. Michael Lammers (2008) |
| Environmental Risk Assessment - Part of the overall Risk / Benefit Assessment of veterinary medicinal products
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Derk Eldert Görich (2008) |
| One Step beyond the eCTD: Update of the Dossier by electronic Variations In Europe and Germany
|
|
[Summary...] |
| |
|
Dr. Nicole Wagner (2007) |
| International Nonproprietary Names (INNs) - A Critical Issue For Biological Medicinal Products
|
|
[Summary...] |
| |
|
Dr. Agnieszka Pietas (2009) |
| Non-Clinical and Clinical Development of Advanced Therapy Medicinal Products (ATMPs)
|
|
[Summary...] |
| |
|
Petra Sulzer (2009) |
| Requirements for and assessments of medical devices utilising animal tissues and their derivatives
|
|
[Summary...] |
| |
|
Rickert, Ralf (2009) |
| A Review of the Availability of Information on Ethics Committee Requirements for Clinical Trials in the EU
|
|
[Summary...] |
| |
|
Dr. Stephanie Mondabon (2009) |
| The European Commission’s "Pharmaceutical Package": An Analysis
|
|
[Summary...] |
| |
|
Dr. Birgitta Sauer (2009) |
| Nonclinical and Clinical Requirements for the Development of an Anticancer Drug Intended for Treatment of Advanced or Late-Stage Disease - The European Perspective
|
|
[Summary...] |
| |
|
Dr. Christel Neiteler (2009) |
| Classification Issues on the Borderline between Medical Devices and Medicinal Products – Review of the Current Regulatory Discussions and Decisions
|
|
[Summary...] |
| |
|
Dr. Birgit Dziadek, geb. Kranke (2009) |
| Generic Substitution of Medicinal Products in the European Economic Area
|
|
[Summary...] |
| |
|
Dr. Johanna Roggemann (2010) |
| An overview on the requirements for the acceptability of invented names for human medicinal products in the Centralised Procedure
|
|
[Summary...] |
| |
|
Dr. Sabine Frenzen (2010) |
| Regulatory Requirements for Biocidal Products in Comparison to Medicinal Products within the EU
|
|
[Summary...] |
| |
|
Anna Paulina Paul (2009) |
| The Polish Pharmaceutical Law – Strenghts and Weaknesses 5 Years after Accession to the European Union. Analysis.
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[Summary...] |
| |
|
Dr. Uwe Goßlar (2009) |
| What are the prospects for a global „biosimilar“development? Comparison of the regulatory requirements for the marketing authorisation of biosimilar products using the example of implemented or proposed legislation in the EU, Canada, Japan and the proposed WHO guidance
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[Summary...] |
| |
|
Dr. Anita Friedrich (2010) |
| Evaluation of Carcinogenicity Studies of Medicinal Products for Human Use Authorised via the Centralised Procedure (1995 – 2009)
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[Summary...] |
| |
|
Heike Mehrer (2010) |
| Subject information and informed consent for subjects participating in clinical trials: How good documents can look like
|
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[Summary...] |
| |
|
Dr. Niels Krebsfänger (2010) |
| Evaluation of Genotoxicity and Carcinogenicity Assessments of Veterinary Medicinal Products Licensed via the European Centralised Procedure
|
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[Summary...] |
| |
|
Viktoria Behse (2010) |
| Current experience with PIP approvals
|
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[Summary...] |
| |
|
Dr. Claudia Matthies (2010) |
| Regulatory Requirements for Medical Devices in Southeast Asia and China
|
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[Summary...] |
| |
|
Anna Geist (2010) |
| Special consideration of OTC switches with respect to application and national implementation from the generic perspective
|
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[Summary...] |
| |
|
Andreas Försch (2010) |
| Biomarkers in preclinical and clinical research: definitions, identification, applications, validation and qualification processes at the FDA and EMA
|
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[Summary...] |
| |
|
Sabine Wolf (2010) |
| European and German Regulatory Requirements to the Design and Validation of Nucleic Acid Tests for Blood Screening
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[Summary...] |
| |
|
Anja Rathgeb (2010) |
| Centralised procedure for OTC products: impact on European market and companies
|
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[Summary...] |
| |
|
Henny Anna Zietze (2010) |
| Involvement of Patients’ and Consumers’ Organisations (PCOs) in activities of the EMA: Development, implementation and outlook
|
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[Summary...] |
| |
|
Minna Haapalahti (2010) |
| Overview of Pathogen Inactivation of Blood Components versus Emerging Pathogens – Measures and Implementation Status
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[Summary...] |
| |
|
Dr. Anne Benzinger (2010) |
| Regulatory requirements for preclinical development of bispecific antibodies
|
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[Summary...] |
| |
|
Barbara Ost (2004) |
| Accreditation of a control laboratory for testing of medicinal products
|
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| |
|
Dr. Katrin Jahn (2006) |
| Zulassung und Handel von Produkten der traditionellen chinesischen Medizin (TCM) in der Schweiz und in Europa unter besonderer Berücksichtigung von Österreich und Deutschland
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[Summary...] |
| |
|
Dr. Katrin Neubert (2007) |
| Development of a rationale for deriving acceptance criteria for the validation of analytical methods in the pharmaceutical quality control
|
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[Summary...] |
| |
|
Michaela Oppold (2007) |
| The opportunities of the new Regulation on medicinal products for paediatric use for existing marketing authorisations – on the example of an off-patent drug substance
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[Summary...] |
| |
|
Dr. Liane Söllner (2011) |
| The need for juvenile animal studies - a critical review
|
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[Summary...] |
| |
|
Beate Menkel (2008) |
| License Application in India with Special Regard to Vaccines
|
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[Summary...] |
| |
|
Dr. Uta Klöcker (2008) |
| Marketing authorization of placebos – legal requirements and requirements to the dossier in accordance to the German drug law
|
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[Summary...] |
| |
|
Dr. Edda Ballweber (2008) |
| In vitro equivalence criteria of orally inhaled products (OIPs) and role of in vitro data in the overall therapeutic equivalence program - A comparison between Europe, Canada and the U.S.
|
|
[Summary...] |
| |
|
Frank Zimmermann (2008) |
| The Centralised Procedure from the Micro, Small and Medium-sized Enterprise's Perspective and Specific Obstacles of SMEs
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Petra Kist (2008) |
| Pharma-Mittelstand – Drug Regulatory Affairs Portfoliostrategie
|
|
[Summary...] |
| |
|
Nadine Stöckl (2008) |
| Optimisation of Master File Procedures for Biologics: Comparison of Master File Procedures - EU and USA
|
|
[Summary...] |
| |
|
Dr. Joachim Gramberg (2005) |
| Über die Abgrenzungsproblematik bei Repellents
|
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| |
|
Dr. Michael Sych (2005) |
| Structure and implementation of an adequate quality assurance system in a pharmaceutical start-up company
|
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| |
|
Elke Wehres-Losch (2005) |
| Die Anmeldung klinischer Prüfungen in Deutschland nach der 12. AMG-Novelle – Erste Erfahrungen und kritische Aspekte aus Sicht der pharmazeutischen Industrie
|
|
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| |
|
Dr. Maria Hambrügge (2006) |
| Effective drug regulation as a promoter for access to medicinal products in developing countries – New initiatives within the legal framework in the EU and regulatory activities by WHO and regional regulatory harmonisation initiatives
|
|
|
| |
|
Dr. Ursula Malter (2003) |
| Regulatory Requirements for Generic Applications within the EU – Chemically Defined Drugs versus Biotechnology-Derived Products
|
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|
| |
|
Heike Mödinger (2003) |
| Variation Procedures of Marketing Authorisations Granted via MRP versus Marketing Authorisations Granted According to National Law in German Speaking Countries (Germany, Austria, Switzerland) Comparison and Discussion of Advantages and Disadvantages
|
|
|
| |
|
Karin Rudolph (2003) |
| Preparation and realization of variation type I + II in a multinational company with regard to a fictive example (change of manufacturer) in consideration of scientific and administrative aspects
|
|
|
| |
|
Esther Timm-Kilian (2003) |
| Development and implementation of measures in a pharmaceutical sales company to deal with drug-related complaints
|
|
|
| |
|
Loneliese Canali (2003) |
| The different regulatory requirements for conducting clinical trials in the EU and the consequences for multinational studies. How will these procedures be changed by implementation of the Clinical Trial Directive 2001/20/EC?
|
|
|
| |
|
Dr. Stefan Hock (2002) |
| Electronic Submissions - The German AMG-Submission Ordinance and its technical implication on the legal environment
|
|
|
| |
|
Dr. Angelika Leinweber (2002) |
| Regulatory Requirements concerning Process Validation: Differentiation of the Requirements for Registration Purpose in Comparison with the Requirements according to GMP
|
|
|
| |
|
Beate Schmidt (2002) |
| Current regulatory requirements for clincal trials in selected EU Member States and the potential impact of the Clinical Trial Directive compared to the U.S. situation
|
|
|
| |
|
Claudia Schmolze (2002) |
| Regulatory Requirements to the Quality of Parenteral Medicinal Products according to the Common Technical Document
|
|
|
| |
|
Dr. Reinhard Bogan (2006) |
| Regulatory requirements for quality management systems in preclinical research and development with special emphasis on the principles of Good Laboratory Practice
|
|
|
| |
|
Dr. Heribert Halex (2004) |
| Regulatory Aspects of Stability Testing of vaccines representative of Biological Medicinal Products
|
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|
| |
|
Tanja Heinrich (2002) |
| A Regulatory Guide through Mutual Recognition Procedure for a Medicinal Product, Germany acting as concerned Member State from a German Drug Regulatory Affairs Manager's point of view
|
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| |
|
Olena Krasichkova (2005) |
| Design Qualification of a Small-Scale Freeze Dryer for Manufacturing of Ophthalmic Lyophilisate Carrier Systems
|
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|
| |
|
Dr. Daniela Monella (2002) |
| Current Regulatory issues in the assessment of the manufacturing of active pharmaceutical ingredients
|
|
|
| |
|
Dr. Irmela Schuller (2002) |
| Key issues of drug regulatory affairs: A synopsis for medical doctors
|
|
|
| |
|
Ngoc Hanh Trieu (2002) |
| The Swiss registration system - current development
|
|
|
| |
|
Claudia Fischer (2007) |
| Investigational Medicinal Product Dossier (IMPD):
|
|
[Summary...] |
| |
|
Dr. Herta Reile (2007) |
| Implications of the new CHMP Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products Summary
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Susanne Sommer (2007) |
| Package Leaflets: Testing and harmonisation in relation to the overall business process in regulatory procedures - An example of the impact of changing regulatory requirements
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Joachim Ahlert (2007) |
| ICH Q8: Pharmaceutical Development. Regulatory Requirements Directed by the New Note for Guidance (EMEA/CHMP/167068/2004) in Comparison to the Previous Guideline (CPMP/QWP/155/96). A Critical View from the Generic Pharmaceutical Industry.
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Anja Then-Kania (2011) |
| Postapproval CMC Changes in the United States with a Focus on Biopharmaceuticals – Current Status and an Outlook in the Pharmaceutical Development
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Girmay Gebremedhin (2011) |
| The Role of Microbiological Test Methods in Enhancing the Availability and Ensuring the Safety of Pharmaceuticals for Human Use
|
|
[Summary...] |
| |
|
Dr. Monika Unha Baik (2011) |
| Stability Testing in the four climatic zones - Purpose, History, and Requirements
|
|
[Summary...] |
| |
|
Silke Dorothea Kilzer (2011) |
| Development of the Counterfeit Directive – more confidence in the legal supply chain? (Focussed on "Basic Requirements for Active Substances used as Starting Materials": ICH Q7, GMP)
|
|
[Summary...] |
| |
|
Sabine Franke (2011) |
| How harmonised are Drug Regulations and Regulatory Decisions in EU and US? Expectation and Reality
|
|
[Summary...] |
| |
|
Daniela Meinl (2011) |
| DCP Slot Allocation within European Health Authorities and its impact on Development and Regulatory Strategies of Generic Companies Summary
|
|
[Summary...] |
| |
|
Dr. René Leubert (2011) |
| The Design Flexibility in Monographs for Excipients
|
|
[Summary...] |
| |
|
Dr. Saskia Siewert (2011) |
| Implementation of Quality by Design in the Pharmaceutical Development of semisolid topical drug products
|
|
[Summary...] |
| |
|
Dr. Stefan Leyers (2011) |
| 'Chemo-similars', a new challenge for regulatory affairs?!
|
|
[Summary...] |
| |
|
Frauke Zeller, geb. Tuchalski (2011) |
| Development of a new medicinal product containing a NCE intended for global marketing taking national regulations and requirements in the MENA region into consideration
|
|
[Summary...] |
| |
|
Dr. Dorothee Klinkowski (2011) |
| Implications of the German Regulation on Therapy Allergens ("Therapieallergene-Verordnung") on the allergen manufacturing industry
|
|
[Summary...] |
| |
|
Judith Beer (2011) |
| 4th Amendment of the Medical Devices Act: First experience with the new application procedure for clinical trials exemplified by an EU-funded multinational trial
|
|
[Summary...] |
| |
|
Kristiane Kempny (2011) |
| Approval of a biological medicinal product within the Mutual Recognition Procedure (RMS: Germany) - regulatory strategies and potential challenges from a consulting company's point of view with regard to current pharmaceutical legislation
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Andrea Aschenbrenner (2011) |
| Registration of Herbal Teas as Traditional Herbal Medicinal Products according to §§39a-d AMG
|
|
[Summary...] |
| |
|
Christian Schlutius (2011) |
| A step beyond module 3 of orodispersible films
|
|
[Summary...] |
| |
|
Christian Heringer (2011) |
| Regulatory requirements for the sterilization of medical devices
|
|
[Summary...] |
| |
|
Stanislaus Awrutski (2010) |
| Drug Regulatory Affairs and Marketing Authorisation in the Post-Soviet countries. Focus: Russia, the Ukraine and Belarus
|
|
[Summary...] |
| |
|
Jürgen Blömer (2012) |
| User Safety Risk Assessment (USRA) - Part of the overall Risk / Benefit Assessment of veterinary medicinal products (VMP) in Europe
|
|
[Summary...] |
| |
|
Klaus Albrecht (2011) |
| PKPD-modelling from a regulatory affairs perspective
|
|
|
| |
|
Dr. Tom Deutschle (2011) |
| Regulatory assessment time for purely national variation and renewal applications in the Nordic Countries - a retrospective data analysis
|
|
[Summary...] |
| |
|
Katrin Hofmann (2011) |
| Regulatory Challenges Due to Globalisation of Drug Development and Manufacture Focusing on the Quality of Medicinal Products
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Petra Regenhard (2011) |
| Regulatory Requirements in the European Union for Avian Vaccines: Impact of the "Guideline on Data Requirements for Immunological Veterinary Medicinal Products intended for Minor Use or Minor Species/Limited Markets" on Clinical Research
|
|
[Summary...] |
| |
|
Stefanie Lauhoff (2011) |
| Die Überarbeitung der Packungsgrößenverordnung im Rahmen des AMNOG und deren praktische Auswirkungen
|
|
[Summary...] |
| |
|
Dr. Günter Waxenecker (2011) |
| The "Risk Based Approach" - an important tool for managing all the duties in Drug Regulatory Affairs
|
|
[Summary...] |
| |
|
Dr. Carolina Cassara (2011) |
| Adjuvants in Human Vaccines
|
|
[Summary...] |
| |
|
Ines Feile (2011) |
| Requirements on the chemical-pharmaceutical documentation for homeopathic and anthroposophic medicinal products of herbal origin - a critial evaluation
|
|
[Summary...] |
| |
|
Marcus Baur (2012) |
| Choice of study location for a First-in-Human study with a biological product - a critical decision for a biotech company
|
|
[Summary...] |
| |
|
Dr. Viktor Ivandic (2012) |
| Methodological Requirements for Early Benefit Assessment in Germany (G-BA/ IQWIG) and Single Technology Appraisal in England (NICE) - a Comparison
|
|
[Summary...] |
| |
|
Martina Krüger Haberkamp (2012) |
| Das Qualitätsmanagement im Blutspendewesen am Beispiel des Blutspendedienstes der Bundeswehr
|
|
[Summary...] |
| |
|
Dr. Christian Wrehlke (2011) |
| Development of a database concept for tracking and maintaining regional/country specific Product Information (PI) and PI requirements
|
|
[Summary...] |
| |
|
José Rodríguez Sánchez (2011) |
| Switzerland: Article 13 Act on Therapeutic Products – A Review
|
|
[Summary...] |
| |
|
Dr. Astrid Gerhardt (2012) |
| Exceptional Japan filing of a biologic mature product
|
|
[Summary...] |
| |
|
Dr. Carmen Boxler |
| "Compassionate Use", its practical implications and comparison of the regulatory framework of France, Spain, Germany and the United Kingdom
|
|
|
| |
|
Dr. Thorsten Externbrink (2011) |
| Generic In-licensing - Points to Consider, Regulatory Aspects and Interdependencies
|
|
[Summary...] |
| |
|
Prof. Dr. Dr. Thomas Bieber (2012) |
| Stratified medicine: A new challenge for the academia, industry, regulators and patients
|
|
[Summary...] |
| |
|
Dr. Alexander Vuia (2011) |
| First revision of the "Guideline on the Investigation of bioequivalence": BCS-based Biowaiver - opportunities and limitations
|
|
[Summary...] |
| |
|
Dr. Holger Berk (2012) |
| The legislative framework for veterinary medicinal products in Europe under revision - A review on primary objectives, key issues, policy options and their impact assessment
|
|
[Summary...] |
| |
|
Christina Pfaffendorf (2011) |
| Development of Generic Oral Human Medicinal Products Suitable for the Registration in the EU as well as the USA – Different Requirements, Feasibility, Time and Cost
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Qiaoqian Luethi-Peng (2011) |
| Comparative review of prescription drug labeling requirements across various regions and considerations for managing Company Core Data Sheet
|
|
[Summary...] |
| |
|
Hella Witt (2012) |
| Should the European Union introduce 'nutrivigilance' for food supplements and dietary foods for special medical purposes?
|
|
[Summary...] |
| |
|
Nicole Dévaud (2012) |
| Veterinary medicinal products authorised for rabbits in the European Union – Causes for insufficient availability and consequences on human and animal health
|
|
[Summary...] |
| |
|
Dr. Laurent Schmitt (2012) |
| An overview of the incentives in the EU and USA and their draw backs to promote drugs for the treatment of rare diseases
|
|
[Summary...] |
| |
|
Xenia Freifrau von Maltzan (2005) |
| A CTD FOR ASEAN – the Harmonisation of Regulatory Aspects in the ASEAN region
|
|
[Summary...] |
| |
|
Anja Lindau (2005) |
| HACCP-A description of the risk system and transference in the pharmaceutical industry
|
|
[Summary...] |
| |
|
Katharina Neumann (2005) |
| New Pharmaceutical Legislation (Review 2004) - The Impact on the Generic Industry
|
|
[Summary...] |
| |
|
Carolin Wedel (2012) |
| Global Development Strategy for Generic Medicinal Products with Regard to Bioequivalence Studies - Special Focus on the Biowaiver Approach in Canada, Australia and Brazil
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Daniela Völker (2002) |
| Current Regulatory Issues in the Assessment of Manufacturing of Active Substances
|
|
[Summary...] |
| |
|
Kirsten Vonde (2001) |
| Requirements an opportunities of an OTC-switch – Comparison between Germany, UK and USA
|
|
[Summary...] |
| |
|
Dr. Antje Wallstab (2003) |
| Effective Change Control Management of Product Information Texts
|
|
[Summary...] |
| |
|
Martin Wiesbeck (2001) |
| E-Commerce and Homecare in Germany - Opportunities and Limitations
|
|
[Summary...] |
| |
|
Dr. Christian Witt (2002) |
| Influence of the EU-enlargement on the procedures for granting marketing authorisations for medicinal products in a single European market
|
|
[Summary...] |
| |
|
Dr. Franz-Josef Braun (2004) |
| The Legal Framework for Parallel Trade in Pharmaceuticals for Human Use in the European Economic Area
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Irmgard Buchkremer-Ratzmann (2000) |
| Special features of the development and regulatory requirements of biotechnological products as defined by part A of the Annex of Commission Regulation 2309/93
|
|
[Summary...] |
| |
|
Dr. Ingeborg Cebulla (2004) |
| Changes to biological medicinal products (Case Study: Vaccines)
|
|
[Summary...] |
| |
|
Dr. Andrea Derix (2002) |
| Intellectual Property Rights for Medicinal Products in an Enlarged European Union
|
|
[Summary...] |
| |
|
Gerd Dievenich (2002) |
| Elektronisches Rezept und elektronischer Gesundheitspass im Rahmen von Telematikentwicklungen in Gesundheitswesen
|
|
[Summary...] |
| |
|
Dr. Bettina Doepner (2001) |
| The Common Technical Document, Module 3 - Quality, Proposal for adaptation to herbal medicinal products
|
|
[Summary...] |
| |
|
Dr. Jan Dütemeyer (2001) |
| Information in the Internet about Medicinal Products Provided by Governmental Institutions in Germany, Great Britain and the United States
|
|
[Summary...] |
| |
|
Dr. med. Klaus Eckhardt (2004) |
| Clinical development of a new chemical entity compared to a somatic cell therapy product for Parkinson´s disease in the regulatory framework of the EU
|
|
[Summary...] |
| |
|
Eva Eisenhut (2002) |
| Comparison of In Vitro Drug Release and In Vivo Data (Bioavailability) of Prolonged Release Oral Dosage Forms - Introduction to Basic Techniques
|
|
[Summary...] |
| |
|
Leonor Enes (2003) |
| A comparative study of generic medicinal products in Europe
|
|
[Summary...] |
| |
|
Veronika Etges (2003) |
| CMC - Variation in a Globally Operating Pharmaceutical Company
|
|
[Summary...] |
| |
|
Dr. Angelika Freund (2004) |
| "Regulations Concerning "Off-Label-Use "of Medicinal Products in Germany"
|
|
[Summary...] |
| |
|
Karen Frischke (2001) |
| The annex to Council Directive 75/318 and its consequences on new and existing marketing authorisations in the EC
|
|
[Summary...] |
| |
|
Britta Ginnow (2004) |
| Impact of the new Variation Regulations 1084/2003 and 1085/2003 on the industrial practice of a multinationally operating pharmaceutical company with regard to the EU enlargement and the multinational procedure in performing variations
|
|
[Summary...] [Volltext als PDF-Datei (5,8 MB)...] |
| |
|
Dr. Beate Golba (2004) |
| Market Surveillance of Medical Devices in Germany and Europe
|
|
[Summary...] |
| |
|
Dr. Sabine Schiemann (2005) |
| New aspects in comparability studies of biotechnological products subject to changes in the manufacturing process
|
|
[Summary...] |
| |
|
Matthias Wilken (2005) |
| Empfehlungen zur Erstellung eines Maßnahmeplans unter Anpassung an die aktuellen gesetzlichen Vorgaben unter spezieller Berücksichtigung der 12. AMG-Novelle
|
|
[Summary...] |
| |
|
Dr. Daniel Schwarz (2005) |
| Regulatory requirements in Europe for the development of active pharmaceutical ingredients derived from transgenic plants
|
|
[Summary...] |
| |
|
Hiu Wah Yuen (2005) |
| Implementing CMC Section of the Clinical Trial Directive
|
|
[Summary...] |
| |
|
Dr. Thomas Stoiber (2005) |
| Introduction of electronic systems supporting the submission management of the Regulatory Affairs department in a medium-sized pharmaceutical company, with special focus on the implementation of the ICH eCTD standard
|
|
[Summary...] |
| |
|
Sabina Freund-Rieger (2009) |
| Market Exclusivity versus Market Penetration: Theory and Practice of Originator – Generic Competition
|
|
[Summary...] |
| |
|
Elwira Baldyga (2012) |
| Biosimilars in the EU and the USA: Impact of regulations on the development, registration and marketing process and consequences from the reimbursement system in Germany
|
|
[Summary...] |
| |
|
Sylvia Streit (2012) |
| Impact of the new Pharmacovigilance legislation on national level
|
|
[Summary...] |
| |
|
Dr. Markus Weidlich (2012) |
| ICH Q11 - Potential Regulatory Implications for the Development and Manufacture of Synthetic Drug Substances Using an Enhanced Approach
|
|
[Summary...] |
| |
|
Ellen Thom (2012) |
| Case study: EYLEA® - A new drug from Bayer Healthcare and pricing under the conditions of AMNOG
|
|
[Summary...] |
| |
|
Andreas Vogt (2013) |
| The planned transformation of Directive 98/79/EC on in vitro diagnostic medical devices into a Regulation. Possible regulatory consequences for the development and release of in vitro diagnostics
|
|
[Summary...] |
| |
|
Christian Biegel (2012) |
| EudraVigilance Medicinal Product Dictionary - a challenge for authorities and marketing authorisation holders
|
|
[Summary...] |
| |
|
Karen Koch (2012) |
| An Overview of the Orphan Drug Status which has been put in place in countries in order to stimulate the research and development of treatments of rare diseases
|
|
[Summary...] |
| |
|
Dr. Florence Loeffler (2012) |
| Veterinary medicinal products for horses in the European Union - an overview
|
|
[Summary...] |
| |
|
Dr. Janinne Sylvie Schmid (2012) |
| Regulatory challenges for the registration of generic transdermal patches - A Guidance for Regulatory Affairs
|
|
[Summary...] |
| |
|
Guido Bockler (2013) |
| The new Directive 2010/63/EU and its implementation in the European Economic Area (EEA): an Overview
|
|
[Summary...] |
| |
|
Dr. Christoph Brenner (2013) |
| Submission-relevant Illustration of Risk Management in Pharmaceutical Development
|
|
[Summary...] |
| |
|
Berit Fasse (2013) |
| Acceptability of brand names for human medicinal products. With focus on German non-generic OTC umbrella brand discussion
|
|
[Summary...] |
| |
|
Dr. Sebastian Specht (2013) |
| ICH - Strengths, Weaknesses and Future Tasks
|
|
[Summary...] |
| |
|
Dr. Anaid Shahbazian (2012) |
| Sicherheit bei Medizinprodukten in Deutschland am Beispiel steriler wiederverwendbarer Instrumente in der Ophthalmologie
|
|
[Summary...] |
| |
|
Dr. Sven Enders (2012) |
| Case Study: An In-Market Drug Approved for Several Indications - AMNOG and Its Impacts
|
|
[Summary...] |
| |
|
Stephanie Gelsen (2012) |
| Legislation around Wholesalers and Impact of new Developments of the EU GDP Guideline
|
|
[Summary...] |
| |
|
Dr. Leonie Hempel (2012) |
| Challenges and Chances of the Development of Biosimilar Monoclonal Antibodies in the EU
|
|
[Summary...] |
| |
|
Judith Leyendecker (2012) |
| Identification of Commercially Confidential Information and Protection of Personal Data - New transparency guidance (1st publication: June 2011) of EMA and HMA especially from the point of view of service companies
|
|
[Summary...] |
| |
|
Dr. Axel Dienemann (2012) |
| Pharmaceutical development of medicines for paediatric use - requirements, challenges and implications
|
|
[Summary...] |
| |
|
Dr. Martin M. Hartge (2012) |
| HTA of orphan oncological medicinal products - A current critical assessment and discussion from authority, KOL and industry point of view
|
|
[Summary...] |
| |
|
Sonja Seeberger (2012) |
| The new Falsified Medicine Directive 2011/62/EU and its requirements for stakeholders
|
|
[Summary...] |
| |
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Dr. Karin Schlegel (2012) |
| Risk Management Plan - The Legislative Changes with Directive 2010/84/EC and Regulation (EC) No 1235/2010
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[Summary...] |
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Dr.Gabriele Sigl-Seifert (2012) |
| Regulatorische Analyse der frühen Nutzenbewertung von Linagliptin, einem innovativen oralen Antidiabetikum
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[Summary...] |
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Stefan Kuhn (2013) |
| Advantages, disadvantages and pitfalls in current registration procedures of medical devices
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[Summary...] |
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Ariane Wölfer (2013) |
| Regulatory requirements for clinical trials in Singapore, Hong Kong, Taiwan and South Korea -hurdles and opportunities, and development strategies
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[Summary...] |
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Inga Kristin Drosse (2013) |
| Antibiotics in Veterinary Medicine – A European Regulatory Perspective
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[Summary...] |
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Jochen Bierlein (2013) |
| Specific requirements of the new Pharmacovigilance legislation on the development and compilation of a dossier for a generic medicinal product (new application and life cycle management acitivities)
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[Summary...] |
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© 2011, DGRA e.V.
Letzte Aktualisierung am:
Donnerstag, 06.11.2008
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