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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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| AUSGEZEICHNETE MASTER-THESIS |
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| Im Folgenden stehen Ihnen die mit "sehr gut" bewerteten Masterarbeiten im Volltext zur Verfügung. |
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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. 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. 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. 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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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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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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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. 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. 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. 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. Beate Hötzl (2003) |
| Biotechnological generics - a matter of science or science fiction?
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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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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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Uta Kästner (2002) |
| Arzneimittelsicherheit Aut-idem eine Gratwanderung zwischen therapeutischem Anspruch und finanziellen Zwängen
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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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Julia Tillkes (2003) |
| Limits of "Essential Similarity" regarding abridged marketing Authorizations
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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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Maren Seip (2003) |
| Biopharmaceutics Classification System - State of the Art in Development and Practice
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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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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. 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. Jens Schletter (2002) |
| Specific regulatory requirements for stem cell-based therapies
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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. 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. Anja Mecklenburg (2003) |
| Strategies for Carcinogenicity Testing of Human Pharmaceuticals
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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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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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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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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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Brigitte Nerl (2001) |
| Maintenance of Generic Marketing Authorizations
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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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Kris Pelzer (2003) |
| Chemical-Pharmaceutical Documentation for Pressurised Metered Dose Inhalers
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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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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. 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. 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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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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Dr. Anja Tischlich (2002) |
| Regulatory and economic conditions for clinical trials in children
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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. 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. 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 Greger (2004) |
| Kritische Bewertung von Arzneimittel-Re-/Parallelimporten in Deutschland
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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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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. Daniela Lieder (2005) |
| Evaluation and consideration of resistance data on the licensing process of antibiotics
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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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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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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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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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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. 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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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. 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. 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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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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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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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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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. 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. Herta Reile (2007) |
| Implications of the new CHMP Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products Summary
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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. 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.
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[Summary...] [Volltext als PDF-Datei...] |
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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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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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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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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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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...] |
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Dr. Ludger Benning (2007) |
| Electronic Submission and the MRP/DCP: How to Compile a Dossier That Will be Accepted at the European Agencies
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Ursula Beikert (geb. Tammler) (2008) |
| REACH – How does it affect the pharmaceutical industry? Consideration of the issue for a medium-sized enterprise
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[Summary...] [Volltext als PDF-Datei...] |
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Frank Zimmermann (2008) |
| The Centralised Procedure from the Micro, Small and Medium-sized Enterprise's Perspective and Specific Obstacles of SMEs
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Dieter Brazel (2010) |
| Regulatory Life Cycle Management of Plasma Protein Therapeutics
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[Summary...] |
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Dr. Jasmin Fahnenstich (2010) |
| Prescription of Cannabis - Regulatory environment and current situation in Germany in comparison with the Netherlands and the USA
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[Summary...] |
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Andrea Krause (2010) |
| How to achieve and maintain compliance for quality documents in a global company
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[Summary...] |
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Dr. Stephanie Schwarz (2010) |
| Make off-patent drugs available to children: Regulatory approaches in Europe and the US
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[Summary...] |
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Natascha Nickelt (2011) |
| Regulatory Assessment of Nanotechnology in Different Areas of Application -an Example of Regulating Emerging Sciences
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[Summary...] |
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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
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[Summary...] |
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Dr. Claudia Karin Wagner (2010) |
| Distribution restrictions (Re-switch of OTC medicines) in Germany and in other selected countries
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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. Manfred Kurz (2006) |
| Registration of antibody based medicinal products
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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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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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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. 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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Dr. Nicole Wagner (2007) |
| International Nonproprietary Names (INNs) - A Critical Issue For Biological Medicinal Products
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[Summary...] |
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Dr. Christine Gillen (2008) |
| Could the Global Harmonization Task Force guidance of a standardized harmonized documentation format succeed in global harmonization?
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[Summary...] |
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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
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[Summary...] |
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Dr. Barbara Römer (2008) |
| 2001/20/EC - A European Directive? Major Regulatory Objectives for a real Harmonisation in Europe
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[Summary...] |
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Dr. Theodore L. Drell IV (2008) |
| Defining the regulatory strategy for the rapid implementation of a multinational, global clinical trial in an oncological indication
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[Summary...] |
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Heli Hulkkonen (2008) |
| Generic Medicinal Products – A Comparison of Regulatory Framework between Germany and Finland
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[Summary...] |
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Dr. Matthias Dormeyer (2008) |
| Regulatory Strategies and Practical Aspects for the Development and Authorisation of Orphan Medicinal Products in the European Union
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[Summary...] |
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Mariela Becker (2008) |
| Experiences with the New Decentralised Procedure – Changes, Limits, Perspectives
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[Summary...] |
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Ines Becker-Schnoor (2008) |
| Sunset Clause- Implementation within the EU and its influence on regulatory strategies
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[Summary...] |
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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.
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[Summary...] |
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Petra Kist (2008) |
| Pharma-Mittelstand – Drug Regulatory Affairs Portfoliostrategie
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[Summary...] |
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Nadine Stöckl (2008) |
| Optimisation of Master File Procedures for Biologics: Comparison of Master File Procedures - EU and USA
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[Summary...] |
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Dr. Tatiana Reimer (2008) |
| Impact of scientific advice on the outcome of marketing authorisation applications submitted to the CHMP between 2004 and 2007
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[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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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. 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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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
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[Summary...] [Volltext als PDF-Datei...] |
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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. 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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Nadine Schliecker (2003) |
| Challenges for the SmPC Harmonisation of Generics in Mutual Recognition
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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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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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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. 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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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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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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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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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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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...] |
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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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Tanja Weber (2007) |
| A Step Beyond Module 3 of Biodegradable Implants
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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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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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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. Michael Bernhard (2007) |
| Quality attributes of biopharmaceuticals: The impact of glycosylation
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[Summary...] |
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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...] |
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Kirsten Martin (2007) |
| Readability User Testing of package leaflets: Regulatory requirements, methodologies and assessment
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[Summary...] |
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Dr. Sabine Schmitz (2007) |
| Pharmaceutical Excipients – Regulatory and GMP Requirements
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[Summary...] |
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Dr. Dirk Schmidt (2007) |
| Impact and Consequences of the PAT Initiatives by FDA and EMEA on New Chemical Entity Synthesis
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[Summary...] |
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Dr. Frank Förster (2011) |
| Development of Alternative Carcinogenicity Test Methods in the Pharmaceutical Industry: Evaluation of the Current Validation/Application Status
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Beatrix Metzner (2008) |
| Comparison of marketing authorization procedures for biotechnological products in the European Union (centralized procedure) and in Japan (J-NDA)
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[Summary...] [Volltext als PDF-Datei...] |
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Dr. Bianca Krafft (2007) |
| Scientific Advice - Value Adding Strategies for Regulatory Agencies and Pharmaceutical Companies
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[Summary...] |
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Dr. Andreas Grummann (2008) |
| Strengthening and Rationalising the European Pharmacovigilance System
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[Summary...] |
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Stephanie Pick (2008) |
| Die Packungsbeilage als Instrument der Verbraucherinformation im Wandel der Zeit
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[Summary...] |
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Dr. Roger Müller-Pfaff (2006) |
| Einführung des Hämaphereseverfahrens in den Blutspendedienst der Bundeswehr
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Dr. Thorsten Henning (2009) |
| Rx-to-OTC switch – Comparison of the Current Regulatory Approaches in Germany, in the UK, and in the USA
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[Summary...] |
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Dr. Ulrich Feil (2009) |
| Replacement, Reduction, Refinement of Animal Testing in Quality Control of Medicinal Products in the EU
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[Summary...] |
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Rainer Brunschier (2008) |
| Generic Drug Submissions in Japan from a Global Player’s Point of View
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[Summary...] |
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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
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[Summary...] |
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Dr. Kim Wuthold (2009) |
| Regulatory requirements of the quality of traditional herbal medicinal products and the resulting challenge for the pharmaceutical industry
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[Summary...] |
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Dr. Maria Teresa Piccini (2009) |
| FDA programs to expedite innovative drug development and review process: Fast Track, Priority Review and Accelerated Approval
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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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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. 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. 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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Dr. Susanne Manhart (2009) |
| Development of a New Active Substance for Treatment of Alzheimer’s Disease – Development from Preclinical Testing to Proof-of-Concept
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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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Claudia Keupp (2009) |
| Portfolio strategies of cytotoxic drugs – current topics of regulatory economy
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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. 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. Stephanie Mondabon (2009) |
| The European Commission’s "Pharmaceutical Package": An Analysis
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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 Lange (2009) |
| The new Variation Regulation. A major step forward?
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[Summary...] |
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Becker, Stephan (2009) |
| Regulatory Considerations on Drug Interaction Studies
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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. Birgit Dziadek, geb. Kranke (2009) |
| Generic Substitution of Medicinal Products in the European Economic Area
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[Summary...] |
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Dr. Johanna Roggemann (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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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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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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Dr. Dietmar Theisen (2010) |
| European Regulatory Framework of Stem Cell-based Medicinal Products
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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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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. 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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Viktoria Behse (2010) |
| Current experience with PIP approvals
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[Summary...] |
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Dr. Claudia Matthies (2010) |
| Regulatory Requirements for Medical Devices in Southeast Asia and China
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[Summary...] |
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Anna Geist (2010) |
| Special consideration of OTC switches with respect to application and national implementation from the generic perspective
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[Summary...] |
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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...] |
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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...] |
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Anja Rathgeb (2010) |
| Centralised procedure for OTC products: impact on European market and companies
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[Summary...] |
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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...] |
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Minna Haapalahti (2010) |
| Overview of Pathogen Inactivation of Blood Components versus Emerging Pathogens – Measures and Implementation Status
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[Summary...] |
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Dr. Anne Benzinger (2010) |
| Regulatory requirements for preclinical development of bispecific antibodies
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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...] [Volltext als PDF-Datei...] |
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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. Michael Lammers (2008) |
| Environmental Risk Assessment - Part of the overall Risk / Benefit Assessment of veterinary medicinal products
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[Summary...] [Volltext als PDF-Datei...] |
| |
|
Bettina Geng (2008) |
| "Die Nachzulassung" – Legal requirements and regulations regarding the pharmaceutical quality of medicinal products from the notification of 1978 until today
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[Summary...] [Volltext als PDF-Datei...] |
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|
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)
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[Summary...] |
| |
|
Dr. Saskia Siewert (2011) |
| Implementation of Quality by Design in the Pharmaceutical Development of semisolid topical drug products
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[Summary...] |
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|
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
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[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Franz Thannberger (2011) |
| A Step beyond Module 3 of "passive" Transdermal Therapeutic Systems
|
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[Summary...] |
| |
|
Dr. Maren Ulrike Koban (2010) |
| Impact of Health Technology Assessment (reimbursement) on considerations for international regulatory strategies
|
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[Summary...] [Volltext als PDF-Datei...] |
| |
|
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
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[Summary...] [Volltext als PDF-Datei...] |
| |
|
Dr. Andrea Aschenbrenner (2011) |
| Registration of Herbal Teas as Traditional Herbal Medicinal Products according to §§39a-d AMG
|
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[Summary...] |
| |
|
Dr. Henning Brohmann (2011) |
| Genotoxicity in mammalian cell assays in vitro: necessity to revise current pharmaceutical regulations?
|
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[Summary...] |
| |
|
Sabine Franke (2011) |
| How harmonised are Drug Regulations and Regulatory Decisions in EU and US? Expectation and Reality
|
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[Summary...] |
| |
|
Stefanie Lauhoff (2011) |
| Die Überarbeitung der Packungsgrößenverordnung im Rahmen des AMNOG und deren praktische Auswirkungen
|
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[Summary...] |
| |
|
Katrin Hofmann (2011) |
| Regulatory Challenges Due to Globalisation of Drug Development and Manufacture Focusing on the Quality of Medicinal Products
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[Summary...] [Volltext als PDF-Datei...] |
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|
Dr. Günter Waxenecker (2011) |
| The "Risk Based Approach" - an important tool for managing all the duties in Drug Regulatory Affairs
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[Summary...] |
| |
|
Dr. Carolina Cassara (2011) |
| Adjuvants in Human Vaccines
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[Summary...] |
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| « zurück |
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© 2011, DGRA e.V.
Letzte Aktualisierung am:
Mittwoch, 23.03.2005
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