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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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Schedestrasse 9
D-53113 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. Eva-Maria Möllenhoff (2005) |
| Requirements for active pharmaceutical ingredients in marketing authorization applications
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[Summary...] |
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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. 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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Gerd Dievenich (2002) |
| Elektronisches Rezept und elektronischer Gesundheitspass im Rahmen von Telematikentwicklungen in Gesundheitswesen
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[Summary...] |
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Dr. Franz-Josef Braun (2004) |
| The Legal Framework for Parallel Trade in Pharmaceuticals for Human Use in the European Economic Area
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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. 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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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
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[Summary...] |
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Dr. Ingeborg Cebulla (2004) |
| Changes to biological medicinal products (Case Study: Vaccines)
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[Summary...] |
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Dr. Andrea Derix (2002) |
| Intellectual Property Rights for Medicinal Products in an Enlarged European Union
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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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Dr. Bettina Doepner (2001) |
| The Common Technical Document, Module 3 - Quality, Proposal for adaptation to herbal medicinal products
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[Summary...] |
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Dr. Jan Dütemeyer (2001) |
| Information in the Internet about Medicinal Products Provided by Governmental Institutions in Germany, Great Britain and the United States
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[Summary...] |
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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
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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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Eva Eisenhut (2002) |
| Comparison of In Vitro Drug Release and In Vivo Data (Bioavailability) of Prolonged Release Oral Dosage Forms - Introduction to Basic Techniques
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[Summary...] |
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Leonor Enes (2003) |
| A comparative study of generic medicinal products in Europe
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[Summary...] |
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Veronika Etges (2003) |
| CMC - Variation in a Globally Operating Pharmaceutical Company
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[Summary...] |
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Dr. Angelika Freund (2004) |
| "Regulations Concerning "Off-Label-Use "of Medicinal Products in Germany"
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[Summary...] |
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Karen Frischke (2001) |
| The annex to Council Directive 75/318 and its consequences on new and existing marketing authorisations in the EC
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[Summary...] |
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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
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[Summary...] [Volltext als PDF-Datei (5,8 MB)...] |
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Dr. Beate Golba (2004) |
| Market Surveillance of Medical Devices in Germany and Europe
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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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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. 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. 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. 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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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. 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. Beate Hötzl (2003) |
| Biotechnological generics - a matter of science or science fiction?
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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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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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Uta Kästner (2002) |
| Arzneimittelsicherheit Aut-idem eine Gratwanderung zwischen therapeutischem Anspruch und finanziellen Zwängen
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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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Rika Kremmer (2003) |
| Regulatory Enviroment for Traditional Herbal Medicinal Products in the European Union
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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. 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. 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. Thomas Lauterbach (2004) |
| Characterization of Impurities during Development of Chemically Synthesized Compounds Regulatory Requirements
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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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Dr. Anja Mecklenburg (2003) |
| Strategies for Carcinogenicity Testing of Human Pharmaceuticals
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[Summary...] |
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Dr. Wolfgang Meder (2004) |
| Rx-to-OTC Switch - Opportunities And Risks With Focus On Statins
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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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Uta Müller (2002) |
| Elektronische Einreichung von Zulassungsunterlagen - Stand und Möglichkeiten für die Zukunft
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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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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. 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. Katrin Sauerland (2001) |
| The Demarcation of Medical Devices and Medicinal Products in the European Union
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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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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. Jens Schletter (2002) |
| Specific regulatory requirements for stem cell-based therapies
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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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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. 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. 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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Maren Seip (2003) |
| Biopharmaceutics Classification System - State of the Art in Development and Practice
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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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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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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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Julia Tillkes (2003) |
| Limits of "Essential Similarity" regarding abridged marketing Authorizations
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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. Daniela Völker (2002) |
| Current Regulatory Issues in the Assessment of Manufacturing of Active Substances
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[Summary...] |
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Kirsten Vonde (2001) |
| Requirements an opportunities of an OTC-switch – Comparison between Germany, UK and USA
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[Summary...] |
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Dr. Antje Wallstab (2003) |
| Effective Change Control Management of Product Information Texts
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[Summary...] |
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Martin Wiesbeck (2001) |
| E-Commerce and Homecare in Germany - Opportunities and Limitations
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[Summary...] |
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Dr. Christian Witt (2002) |
| Influence of the EU-enlargement on the procedures for granting marketing authorisations for medicinal products in a single European market
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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. 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. 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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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. Ulrike Domack (2004) |
| Regulatory Science on Orphan Drug Application within Paediatric Field
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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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Dr. Ulrike Greger (2004) |
| Kritische Bewertung von Arzneimittel-Re-/Parallelimporten in Deutschland
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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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Monika Merfels (2004) |
| The new regulatory framework for authorisation and reevaluation of feed additives by the European Food Safety Authority in the European Union
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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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Matthias Wilken (2005) |
| Empfehlungen zur Erstellung eines Maßnahmeplans unter Anpassung an die aktuellen gesetzlichen Vorgaben unter spezieller Berücksichtigung der 12. AMG-Novelle
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[Summary...] |
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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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Xenia Freifrau von Maltzan (2005) |
| A CTD FOR ASEAN – the Harmonisation of Regulatory Aspects in the ASEAN region
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[Summary...] |
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Anja Lindau (2005) |
| HACCP-A description of the risk system and transference in the pharmaceutical industry
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[Summary...] |
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Katharina Neumann (2005) |
| New Pharmaceutical Legislation (Review 2004) - The Impact on the Generic Industry
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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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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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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. 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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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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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. 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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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. Sabine Schiemann (2005) |
| New aspects in comparability studies of biotechnological products subject to changes in the manufacturing process
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[Summary...] |
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Dr. Daniel Schwarz (2005) |
| Regulatory requirements in Europe for the development of active pharmaceutical ingredients derived from transgenic plants
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[Summary...] |
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Hiu Wah Yuen (2005) |
| Implementing CMC Section of the Clinical Trial Directive
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[Summary...] |
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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
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[Summary...] |
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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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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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Claudia Koritke |
| Essential Aspects of Quality Assurance in Outsourcing Production and Purchase of Active Pharmaceutical Ingredients
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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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Dr. Dorith Stauch-Steffens (2002) |
| Regulatory Requirements concerning Development Pharmaceutics and Manufacturing of a Medicinal Product: A Critical Analysis from Pharmaceutical Technological View
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[Summary...] |
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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?
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Dr. Elke Bertram-Neis (2001) |
| Orphan Drugs and rare diseases
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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. Katrin Mayer (2006) |
| Maintenance / life cycle management of a MRP-product – A case study
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[Summary...] |
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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“
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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. Sabine Drechsler (2006) |
| The re-evaluation regulatory assessment procedure for old herbal medicinal products in Germany, focussing on clinical aspects
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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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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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Dr. Ursula Bonsmann (2006) |
| Biowaivers Based on the BCS – Only for Class I ?
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[Summary...] |
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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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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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Sylvaine Hartmann (2006) |
| Change Control and Variations in Chemistry – Consequences on the regulatory workload for Active Substance Manufacturers
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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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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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|
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...] |
| |
|
Renzo Wolbold (2006) |
| The regulatory environment and requirements for biological and biotechnology-derived medicinal products in Japan
|
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[Summary...] |
| |
|
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...] |
| |
|
Anna Geist (2010) |
| Special consideration of OTC switches with respect to application and national implementation from the generic perspective
|
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[Summary...] |
| |
|
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. 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 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
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[Summary...] [Volltext als PDF-Datei...] |
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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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Claudia Lydia Abel (2001) |
| Haemophilia Conventional Therapy and Gene Therapy related to EU-Guidelines
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Dr. Susanne Donat (2001) |
| Mechanistic considerations on the carcinogenic effects of fibrates
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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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Susanne Kästner (2000) |
| Review 2000 – Review of Regulatory Procedure by the European Commission
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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?
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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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|
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
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| |
|
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
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| |
|
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
|
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| |
|
Esther Timm-Kilian (2003) |
| Development and implementation of measures in a pharmaceutical sales company to deal with drug-related complaints
|
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| |
|
Doris Göller (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
|
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| |
|
Dr. Stefan Hock (2002) |
| Electronic Submissions - The German AMG-Submission Ordinance and its technical implication on the legal environment
|
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| |
|
Dr. Angelika Leinweber (2002) |
| Regulatory Requirements concerning Process Validation: Differentiation of the Requirements for Registration Purpose in Comparison with the Requirements according to GMP
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| |
|
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
|
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| |
|
Claudia Schmolze (2002) |
| Regulatory Requirements to the Quality of Parenteral Medicinal Products according to the Common Technical Document
|
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| |
|
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
|
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| |
|
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
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| |
|
Barbara Ost (2004) |
| Accreditation of a control laboratory for testing of medicinal products
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| |
|
Dr. Irmela Schuller (2002) |
| Key issues of drug regulatory affairs: A synopsis for medical doctors
|
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| |
|
Ngoc Hanh Trieu (2002) |
| The Swiss registration system - current development
|
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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...] |
| |
|
Claudia Fischer (2007) |
| Investigational Medicinal Product Dossier (IMPD):
|
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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...] |
| |
|
Anja Rathgeb (2010) |
| Centralised procedure for OTC products: impact on European market and companies
|
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[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...] |
| |
|
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. 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...] |
| |
|
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...] |
| |
|
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...] |
| |
|
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...] |
| |
|
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...] |
| |
|
Tünde Molnár (2007) |
| Generics Medicines in the Centralised Procedure
|
|
[Summary...] |
| |
|
Martin Watzl (2007) |
| The New Paediatric Regulation in the EU – Development, Implications and Comparison with US Experiences in Paediatric Drug Development
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Becker, Stephan (2009) |
| Regulatory Considerations on Drug Interaction Studies
|
|
[Summary...] |
| |
|
Tanja Weber (2007) |
| A Step Beyond Module 3 of Biodegradable Implants
|
|
[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...] |
| |
|
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...] |
| |
|
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...] |
| |
|
Angelika Ommeln (2007) |
| Regulatory Data Analysis for the development of a database for country specific requirements
|
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[Summary...] |
| |
|
Wieland Peschel (2007) |
| The regulatory challenge to improve the safety of Traditional Herbal Medicinal Products in Europe
|
|
[Summary...] |
| |
|
Dr. Frank Jeblonski (2007) |
| New developments in European registration procedures and requirements, in particular consideration of biological/biotechnological-derived medicinal products
|
|
[Summary...] |
| |
|
Ariane Prochaska (2007) |
| Assignment of GMP data within application dossiers and during external inspections
|
|
[Summary...] |
| |
|
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
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Sabine Wolf (2010) |
| European and German Regulatory Requirements to the Design and Validation of Nucleic Acid Tests for Blood Screening
|
|
[Summary...] |
| |
|
Dr. Claudia Matthies (2010) |
| Regulatory Requirements for Medical Devices in Southeast Asia and China
|
|
[Summary...] |
| |
|
Claudia Kristl (2010) |
| Key (Safety) Information in Readability User Testings
|
|
[Summary...] |
| |
|
Dr. Stefan Zwilling (2007) |
| Monoclonal antibodies developed as anticancer drugs: EU clinical trial application with focus on IMPD requirements
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Ulrich Fritsche (2007) |
| An Overview of the Regulatory Framework of Fixed Dose Combination Medicinal Products (FDC)
|
|
[Summary...] |
| |
|
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
|
|
[Summary...] |
| |
|
Seval Tangut (2007) |
| New Regulatory Environment in Turkey
|
|
[Summary...] |
| |
|
Dr. Ursula Protin (2007) |
| First experiences with Conditional Marketing Authorisations in the EU: requirements, obligations, initial experiences and perspectives
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
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
|
|
[Summary...] |
| |
|
Dr. Michael Bernhard (2007) |
| Quality attributes of biopharmaceuticals: The impact of glycosylation
|
|
[Summary...] |
| |
|
Dr. Silvia Sanner (2007) |
| Registration Procedures in South Africa
|
|
[Summary...] |
| |
|
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?
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
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
|
|
[Summary...] |
| |
|
Jörg Cselovszky (2007) |
| The New Regulatory Framework for Health Claims in the Eurpean Union – Impact on the Demarcation of Food to Medicinal Products?
|
|
[Summary...] |
| |
|
Dr. Peter Satter (2007) |
| Assessment of potential similarity between orphan drugs
|
|
[Summary...] |
| |
|
Dr. Desi W. Soegiarto (2007) |
| Changes of Pharmacovigilance Requirements within the Scope of Volume 9A and Related EU Guidelines
|
|
[Summary...] |
| |
|
Dr. Tong Zhang (2007) |
| Audit Check List for Sterile Active Pharmaceutical Ingredients
|
|
[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...] |
| |
|
Kirsten Martin (2007) |
| Readability User Testing of package leaflets: Regulatory requirements, methodologies and assessment
|
|
[Summary...] |
| |
|
Dr. Michael Walser (2007) |
| Analytical Method Validation: Compilation of Relevant Legislation, Guidelines, and Literature
|
|
[Summary...] |
| |
|
Dr. Sabine Schmitz (2007) |
| Pharmaceutical Excipients – Regulatory and GMP Requirements
|
|
[Summary...] |
| |
|
Anneke Hackling (2007) |
| Clinical Trials in China
|
|
[Summary...] |
| |
|
Dr. Zoran Pavlovski (2007) |
| Essential regulatory requirements in the United States related to medical devices intended for human use
|
|
[Summary...] |
| |
|
Dr. Barbara Römer (2008) |
| 2001/20/EC - A European Directive? Major Regulatory Objectives for a real Harmonisation in Europe
|
|
[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. 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. Martin Wendland (2008) |
| Regulatory guidance on comparability studies for biological products following changes to the manufacturing process and analytical procedures
|
|
[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. 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...] |
| |
|
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. 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. 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...] |
| |
|
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...] |
| |
|
Dr. Michael Lammers (2008) |
| Environmental Risk Assessment - Part of the overall Risk / Benefit Assessment of veterinary medicinal products
|
|
[Summary...] [Volltext als PDF-Datei...] |
| |
|
Beate Menkel (2008) |
| License Application in India with Special Regard to Vaccines
|
|
[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...] |
| |
|
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. 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...] |
| |
|
Dr. Uta Klöcker (2008) |
| Marketing authorization of placebos – legal requirements and requirements to the dossier in accordance to the German drug law
|
|
[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...] |
| |
|
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...] |
| |
|
Dr. Benita von Glahn (2008) |
| Post marketing Activities in Japan compared to EU and USA
|
|
[Summary...] |
| |
|
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. Sanjiv Verma (2008) |
| The Regulatory Framework concerning the Import of Medicinal Products in India and in the European Union (e.g. Germany)
|
|
[Summary...] |
| |
|
Michael Hahn (2009) |
| Die Auswirkungen der Arzneimittelrabattverträge nach dem GKV-Wettbewerbsstärkungsgesetz auf den deutschen Generikamarkt
|
|
[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
|
|
|
| |
|
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. 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. Birgit Dziadek, geb. Kranke (2009) |
| Generic Substitution of Medicinal Products in the European Economic Area
|
|
[Summary...] |
| |
|
Dr. Agnieszka Pietas (2009) |
| Non-Clinical and Clinical Development of Advanced Therapy Medicinal Products (ATMPs)
|
|
[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...] |
| |
|
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...] |
| |
|
Dr. Kim Wuthold (2009) |
| Regulatory requirements of the quality of traditional herbal medicinal products and the resulting challenge for the pharmaceutical industry
|
|
[Summary...] |
| |
|
Dr. Maria Teresa Piccini (2009) |
| FDA programs to expedite innovative drug development and review process: Fast Track, Priority Review and Accelerated Approval
|
|
[Summary...] |
| |
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Dr. Ulrich Reichert (2009) |
| Implementing the Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents (EMEA/CHMP/SWP/4446/2000)
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[Summary...] [Volltext als PDF-Datei...] |
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Claudia Keupp (2009) |
| Portfolio strategies of cytotoxic drugs – current topics of regulatory economy
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[Summary...] |
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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
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[Summary...] |
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Dr. Rüdiger Vallon (2009) |
| Regulatory framework for advanced therapy medicinal products (ATMPs) according to the Regulation (EC) No 1394/2007
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[Summary...] |
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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)
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[Summary...] |
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Dr. Nicole Max (2009) |
| Legal proposal to allow pharmaceutical companies to provide information to patients on prescription-only medicines – a controversial discussion
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[Summary...] |
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Angela Röder (2009) |
| Impact of the genotoxic requirements on the generic industry
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[Summary...] |
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Sabina Freund-Rieger (2009) |
| Market Exclusivity versus Market Penetration: Theory and Practice of Originator – Generic Competition
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[Summary...] |
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Dr. Christa Pfleiderer (2009) |
| Regulatory Requirements for Pharmaceuticals, Biotechnological Products, and Biosimilars in Latin America: Common Requirements and Differences
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[Summary...] |
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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
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[Summary...] |
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Dr. Susanne Vambrie (2009) |
| Regulatory Requirements for the Clinical Development of New Therapies for the Treatment of Alzheimer’s Disease
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[Summary...] [Volltext als PDF-Datei...] |
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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
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[Summary...] |
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Jessica Luppus (2010) |
| National Requirements on Direct to Healthcare Professional Communication in the European Economic Area
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[Summary...] |
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Petra Sulzer (2009) |
| Requirements for and assessments of medical devices utilising animal tissues and their derivatives
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[Summary...] |
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Viola Hieble-Gerhard (2009) |
| Risk-based management of GMP audits within the context of supplier relationships – an approach for a medium-sized pharmaceutical company
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[Summary...] |
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Rickert, Ralf (2009) |
| A Review of the Availability of Information on Ethics Committee Requirements for Clinical Trials in the EU
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[Summary...] |
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Dr. Stephanie Mondabon (2009) |
| The European Commission’s "Pharmaceutical Package": An Analysis
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[Summary...] |
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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...] |
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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...] |
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Viktoria Behse (2010) |
| Current experience with PIP approvals
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[Summary...] |
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Dr. Susanne Lange (2009) |
| The new Variation Regulation. A major step forward?
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[Summary...] |
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Houmyra Kazimie (2009) |
| European and national (German) databases with regard to clinical trials involving children
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[Summary...] |
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Dr. Christel Neiteler (2009) |
| Classification Issues on the Borderline between Medical Devices and Medicinal Products – Review of the Current Regulatory Discussions and Decisions
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[Summary...] |
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Dr. Johanna Richter (2010) |
| An overview on the requirements for the acceptability of invented names for human medicinal products in the Centralised Procedure
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[Summary...] |
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Dr. Sabine Frenzen (2010) |
| Regulatory Requirements for Biocidal Products in Comparison to Medicinal Products within the EU
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[Summary...] |
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Jiqing Madeleine-Wang (2004) |
| A Comparison of Generic Submission in Europe and in Asian Countries
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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...] |
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Gudrun Pfeffer (2010) |
| Biologics in Emerging Markets – Regulatory Strategy and Requirements
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[Summary...] |
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Stanislaus Awrutski (2010) |
| Drug Regulatory Affairs and Marketing Authorisation in the Post-Soviet countries. Focus: Russia, the Ukraine and Belarus.
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[Summary...] |
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Sigrun Adrian (2010) |
| Die Entwicklung unterschiedlicher Rechtsvorschriften und deren Überwachung im Bereich der Sicherheit von Arzneimitteln und Medizinprodukten in Deutschland (Pharmako- und Medizinproduktevigilanz)
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[Summary...] |
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Dr. Dietmar Theisen (2010) |
| European Regulatory Framework of Stem Cell-based Medicinal Products
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Frank Pietsch (2010) |
| Clinical Trials with Pharmaceuticals for Human Use - Ethical and Regulatory Aspects, Future Challenges
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[Summary...] |
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Oliver Klaas (2008) |
| Process validation of a medicinal product: Compilation of relevant legislative, guidelines and literature
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[Summary...] |
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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)
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. med. Maria Ida Behrens (2010) |
| Chances for children with rare diseases under the Regulation EC 1901/2006
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[Summary...] |
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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...] |
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Frank Michaelsen (2010) |
| Changes to clinical reporting requirements within the scope of title VII of the FDA Amendment ACT (FDAAA): An Industry Perspective
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[Summary...] |
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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...] |
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Annette Kiesewetter (2010) |
| The Declaration of Helsinki and its Revisions – A Mirror of the History of Ethical and Social Debates in Clinical Research
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[Summary...] |
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Martin Knieps (2010) |
| Regulatory and Practical Risk Management of Potential Drug-Drug Interactions
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[Summary...] |
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Stefanie Muth (2010) |
| Single CTA - an Option for Drug Development in Europe
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[Summary...] |
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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
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[Summary...] |
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Anna Volodina (2010) |
| Clinical Studies in Eastern Europe: critical assessment of the regulatory requirements
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[Summary...] |
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Dr. Marko Kaulich (2010) |
| Change Control Systems in Europe – how are they influenced by Regulation EC1234/2008 and Directive 2009/53?
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[Summary...] |
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Dagmar Hintz (2010) |
| System regulating Medical Devices for Use in Animals
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[Summary...] |
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© 2009, DGRA e.V.
Letzte Aktualisierung am:
Donnerstag, 06.11.2008 |
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