| 2002 |
Sandra Strobl |
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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| 2002 |
Dr. Anja Tischlich |
Regulatory and economic conditions for clinical trials in children *** |
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| 2002 |
Ngoc Hanh Trieu |
The Swiss registration system - current development |
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| 2002 |
Dr. Daniela Völker |
Current Regulatory Issues in the Assessment of Manufacturing of Active Substances *** |
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| 2002 |
Dr. Christian Witt |
Influence of the EU-enlargement on the procedures for granting marketing authorisations for medicinal products in a single European market *** |
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| 2001 |
Claudia Lydia Abel |
Haemophilia Conventional Therapy and Gene Therapy related to EU-Guidelines *** |
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| 2001 |
Dr. Beate Ackermann |
The Internet presentation of national regulatory authorities in Europe and Japan |
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| 2001 |
Dr. Elke Bertram-Neis |
Orphan Drugs and rare diseases |
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| 2001 |
Dr. Michaela Bleile-Röhrlich |
Established active substances: Process of registration and regulatory strategy for submissions in the EU *** |
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| 2001 |
Dr. Bettina Doepner |
The Common Technical Document, Module 3 - Quality, Proposal for adaptation to herbal medicinal products *** |
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| 2001 |
Dr. Susanne Donat |
Mechanistic considerations on the carcinogenic effects of fibrates *** |
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| 2001 |
Dr. Jan Dütemeyer |
Information in the Internet about Medicinal Products Provided by Governmental Institutions in Germany, Great Britain and the United States |
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| 2001 |
Karen Frischke |
The annex to Council Directive 75/318 and its consequences on new and existing marketing authorisations in the EC *** |
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| 2001 |
Dr. Karin Heidenreich |
Review 2001: The future of the Mutual Recognition Procedure including special aspects of the EU-enlargement *** |
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| 2001 |
Dr. Joachim Heinze |
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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| 2001 |
Dr. Klaus Hohenleitner |
"The quality of the active substance - A look at the different regulatory requirements" |
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| 2001 |
Dr. Alexander Kainz |
Developing biopharmaceuticals - Regulatory aspects of the safety evaluation of monoclonal antibodies in the United States and in Europe *** |
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| 2001 |
Brigitte Nerl |
Maintenance of Generic Marketing Authorizations *** |
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| 2001 |
Dr. Carolin Notheis |
Regulatory requirements concerning the quality of herbal medicinal products under the EU pharmaceutical and national food legislation *** |
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| 2001 |
Dr. Katrin Sauerland |
The Demarcation of Medical Devices and Medicinal Products in the European Union *** |
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