| 2006 |
Claudia Hahne |
Angemessenheit der Regelungen zum Vertrieb von Medizinprodukten |
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| 2006 |
Dr. Maria Hambrügge |
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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| 2006 |
Sylvaine Hartmann |
Change Control and Variations in Chemistry Consequences on the regulatory workload for Active Substance Manufacturers |
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| 2006 |
Dr. Katrin Jahn |
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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| 2006 |
Dr. Silke Jung |
New drug substances with abuse potential: Points to consider for the development and marketing |
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| 2006 |
Dr. Sibylle Kaiser |
Tissue engineered products Need and requirements for an appropriate harmonised EU regulatory framework |
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| 2006 |
Dr. Cortina Kaletta |
Overview of the Regulatory Environment for Developing New Vaccines Including the Specific Smallpox Vaccine and Pandemic Influenza Virus Vaccines |
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| 2006 |
Anette Keiser |
Preparation of a check list to perform GMP-Audits of contract manufacturers following relevant provisions of law. |
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| 2006 |
Anne Louise Kirkegaard |
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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| 2006 |
Dr. Angelika Koch |
Möglichkeiten und Grenzen der Vermarktung von pflanzlichen Produkten |
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| 2006 |
Dr. Manfred Kurz |
Registration of antibody based medicinal products |
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| 2006 |
Dr. Katrin Mayer |
Maintenance / life cycle management of a MRP-product A case study |
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| 2006 |
Dr. Roger Müller-Pfaff |
Einführung des Hämaphereseverfahrens in den Blutspendedienst der Bundeswehr |
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| 2006 |
Kristina Mumber |
Regulatory Environment for medicinal products in Russian Federation |
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| 2006 |
Dr. Christiane Pering |
„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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| 2006 |
Gabriele Schäfer |
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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| 2006 |
Dr. Folker Spitzenberger |
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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| 2006 |
Dr. med. vet. Flurina Stucki |
New approaches and requirements in the registration procedure of MUMS-veterinary medicinal products. A comparison between USA, EU and Switzerland |
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| 2006 |
Annika Weyand |
Global Generic Business: Regulatory oriented Analysis of Development versus Licensing |
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| 2006 |
Dr. Astrid Weyermann |
Labelling requirements for investigational medicinal products in multinational studies: bureaucratic cost driver or added value? |
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