| 2006 |
Renzo Wolbold |
The regulatory environment and requirements for biological and biotechnology-derived medicinal products in Japan |
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| 2005 |
Stefanie Abt |
Generic applications after implementation of the new EU pharmaceutical legislation: Criteria for the choice of the Marketing Authorisation Procedure |
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| 2005 |
Josefine Bauer |
Plasma Master File - A Concept for Plasma-derived Medicinal Products |
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| 2005 |
Dr. Barbara Blumbach |
Comparison of the regulatory environment for herbal medicinal products in the three ICH regions: EU, US and Japan |
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| 2005 |
Katrin Dürr |
Comparison of marketing authorisations procedures for biotechnological products in the European Union and in Switzerland |
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| 2005 |
Xenia Freifrau von Maltzan |
A CTD FOR ASEAN - The Harmonisation of Regulatory Aspects in the ASEAN region |
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| 2005 |
Dr. Miriam Gensler |
Generic medicines Quo vadis essential similarity? |
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| 2005 |
Dr. Susanne Gluding |
Chemical and Toxicological Qualification of Plastic Packaging Materials for Sterile Solutions |
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| 2005 |
Dr. Rudolf Gmeinbauer |
Decentralised Procedure, Mutual Recognition Procedure and Readability of SPC, PL, Labelling |
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| 2005 |
Dr. Joachim Gramberg |
Über die Abgrenzungsproblematik bei Repellents |
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| 2005 |
Dr. Markus Hartmann |
Impact of the new legislative framework within the European Union on non-commercial clinical research and investigator-initiated trials: a cross-European analysis with focus on oncology |
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| 2005 |
Dr. Marion Heinzkill |
Marketing Authorisation Procedures under the New Medicines Legislation Impact on the Pharmaceutical Research Industry and Strategic Aspects |
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| 2005 |
Andrea Hörner |
Describe the CADREAC-procedure for a product which was authorized via mutual recognition procedure in the EU and ... |
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| 2005 |
Timea Janosi |
Parametric release of sterility of parenteral medicinal products |
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| 2005 |
Dr. Michael Klimars |
Global Requirements for Stability Testing - Are they Realistic for All Climatic Zones? A Critical Evaluation |
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| 2005 |
Dr. Andrea Klüting |
The Effects of the 12th Amendment to the German Pharmaceuticals Act on Clinical Trials in Academic Institutions and the Pharmaceutical Industry |
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| 2005 |
Olena Krasichkova |
Design Qualification of a Small-Scale Freeze Dryer for Manufacturing of Ophthalmic Lyophilisate Carrier Systems |
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| 2005 |
Dr. Jutta Lange |
Tooth Bleaching Products - Medical Devices or Cosmetic Products? |
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| 2005 |
Stefanie Lemke |
Changes in the Field of Pharmacovigilance within the Scope of the 12th amendment and the drafted 14th amendment of the German Drug Law and the related EU legislation |
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| 2005 |
Dr. Daniela Lieder |
Evaluation and consideration of resistance data on the licensing process of antibiotics |
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