| 2006 |
Anne Althoff |
Demarcation of Herbal Borderline Products Medicinal Products or Food Supplements? *** |
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| 2006 |
Dr. Tatyana Benisheva-Dimitrova |
Challenges For The Pharmaceutical Legislative Implementation In Terms Of An Accelerated Market Access After October 2005 *** |
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| 2006 |
Dr. Markus Beßeling |
European decentralised procedures for marketing authorisation Differences and similarities between applications of veterinary and human medicinal products *** |
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| 2006 |
Dr. Reinhard Bogan |
Regulatory requirements for quality management systems in preclinical research and development with special emphasis on the principles of Good Laboratory Practice |
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| 2006 |
Dr. Ursula Bonsmann |
Biowaivers Based on the BCS Only for Class I |
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| 2006 |
Thurid Buch, geb. Fassbender |
The (European) Public Assessment Report as an extended part of the European application procedure - Regulatory background and practical considerations |
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| 2006 |
Dr. Sabine Drechsler |
The re-evaluation regulatory assessment procedure for old herbal medicinal products in Germany, focussing on clinical aspects *** |
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| 2006 |
Monika Frei |
Parallel import of generic medicinal products - Possible impacts of the Kohlpharma Case *** |
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| 2006 |
Dr. Hans-Joachim Gamperl |
Drug Risk Management from an Industry Perspective - a Task for the Life Time of a Medicinal Product *** |
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| 2006 |
Ellen Güttler |
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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| 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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