| 2004 |
Dr. Beate Golba |
Market Surveillance of Medical Devices in Germany and Europe |
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| 2004 |
Dr. Daniel Gommel |
Developments in Regulatory Pharmaceutical Toxicology: |
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| 2004 |
Dr. Gisela Greger |
Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products *** |
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| 2004 |
Dr. Ulrike Greger |
Kritische Bewertung von Arzneimittel-Re-/Parallelimporten in Deutschland *** |
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| 2004 |
Dr. Heribert Halex |
Regulatory Aspects of Stability Testing of vaccines representative of Biological Medicinal Products |
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| 2004 |
Claudia Hettenkofer |
Implementation of an internal Standard Operating Procedure for the Preparation of Mutual Recognition Variations *** |
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| 2004 |
Dr. Petra Heyen |
Regulatory Intelligence as the basis for Regulatory Strategy and Global Drug Development *** |
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| 2004 |
Anja Hilse |
Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing for blister packs |
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| 2004 |
Dr. Thomas Lauterbach |
Characterization of Impurities during Development of Chemically Synthesized Compounds Regulatory Requirements *** |
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| 2004 |
Jiqing Madeleine-Wang |
A Comparison of Generic Submission in Europe and in Asian Countries |
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| 2004 |
Dr. Wolfgang Meder |
Rx-to-OTC Switch - Opportunities And Risks With Focus On Statins |
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| 2004 |
Viraj Mehta |
Trade Related Aspects of Intellectual Property Rights and Pharmaceuticals: The Impact of Extended Protection on India *** |
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| 2004 |
Monika Merfels |
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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| 2004 |
Bettina Missner |
National and International Information Exchange through Vigilance Reports |
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| 2004 |
Dr. Ursula Moosbauer |
The Impact of Stereoisomerism on the Regulation Procedure on the Example of Antibiotics *** |
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| 2004 |
Barbara Ost |
Accreditation of a control laboratory for testing of medicinal products |
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| 2004 |
Dr. Beate Preuss |
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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| 2004 |
Dr. Jan Richter |
Scientific and regulatory concepts for the development of molecular targeted anti-cancer drugs *** |
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| 2004 |
Anja Kirsten Schiefer |
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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| 2004 |
Dr. Elmar Hermann Schmitt |
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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