| 2002 |
Andrea Schorr |
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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| 2002 |
Dr. Diane Seimetz |
Early Market Access - Regulatory Environment in the EU and the USA and Essential Requirements within the Pharmaceutical Company *** |
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| 2002 |
Dr. Anja Tischlich |
Regulatory and economic conditions for clinical trials in children *** |
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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. 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. 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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| 2001 |
Kirsten Vonde |
Requirements an opportunities of an OTC-switch Comparison between Germany, UK and USA *** |
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| 2001 |
Anette Wiesemann-Fuhr |
Compare the FDA, EMEA and BfArM internet publication policy especially on approval, pharmacovigilance and Drugs on the horizon *** |
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| 2000 |
Dr. Irmgard Buchkremer-Ratzmann |
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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| 2000 |
Dr. Christine Ernst |
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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| 2000 |
Susanne Kästner |
Review 2000 Review of Regulatory Procedure by the European Commission *** |
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Pharmaceutical regulatory landscape in the United Kingdom after the Brexit and current regulatory changes, with focus on the Windsor Framework and the International Recognition Procedure *** |
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