| 2010 |
Wiebke Gesine Kamp |
Application for Marketing Authorisation for a Generic Medicinal Product in Europe, USA and South Korea. Development of a Regulatory Strategy considering the different Regulatory Requirements. |
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| 2010 |
Dr. Marko Kaulich |
Change Control Systems in Europe - How are they influenced by Regulation EC1234/2008 and Directive 2009/53? *** |
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| 2010 |
Santy Kerb |
Application of Company Core Data Sheet (CCDS) in globally established medicinal products to ensure the accuracy of product information across international markets |
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| 2010 |
Annette Kiesewetter |
The Declaration of Helsinki and its Revisions A Mirror of the History of Ethical and Social Debates in Clinical Research |
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| 2010 |
Martin Knieps |
Regulatory and Practical Risk Management of Potential Drug-Drug Interactions |
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| 2010 |
Dr. Maren Ulrike Koban |
Impact of Health Technology Assessment (reimbursement) on considerations for international regulatory strategies *** |
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| 2010 |
Dr. Carsten Kratzsch |
On the Development and Application for Marketing Authorizations for Antidotes for the Treatment of Intoxications with Organophosphates and Nerve Agents |
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| 2010 |
Andrea Krause |
How to achieve and maintain compliance for quality documents in a global company *** |
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| 2010 |
Dr. Niels Krebsfänger |
Evaluation of Genotoxicity and Carcinogenicity Assessments of Veterinary Medicinal Products Licensed via the European Centralised Procedure *** |
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| 2010 |
Claudia Kristl |
Key (Safety) Information in Readability User Testings *** |
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| 2010 |
Dr. Anna Silke Limpert |
Quality of Allergen Products for Specific Immunotherapy - A Guidance for Industry for Compilation of Module 3 for the EU CTD (Quality) Considering the German Therapy - Allergen Ordinance, the revised European Pharmacopoeia Monograph on Allergen Products (2010:1063) and the new "Guideline on Allergen Products - Production and Quality Issues" (EMEA/CHMP/BWP/304821/2007) *** |
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| 2010 |
Jessica Luppus |
National Requirements on Direct to Healthcare Professional Communication in the European Economic Area |
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| 2010 |
Dr. Claudia Matthies |
Regulatory Requirements for Medical Devices in Southeast Asia and China *** |
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| 2010 |
Heike Mehrer |
Subject information and informed consent for subjects participating in clinical trials: How good documents can look like *** |
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| 2010 |
Frank Michaelsen |
Changes to clinical reporting requirements within the scope of title VII of the FDA Amendment ACT (FDAAA): An Industry Perspective |
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| 2010 |
Stefanie Muth |
Single CTA - an Option for Drug Development in Europe *** |
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| 2010 |
Victoria Naumann |
Regulatory Text Mining in the field of Centralised Procedures for Human Medicinal Products |
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| 2010 |
Gudrun Pfeffer |
Biologics in Emerging Markets - Regulatory Strategy and Requirements |
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| 2010 |
Frank Pietsch |
Clinical Trials with Pharmaceuticals for Human Use - Ethical and Regulatory Aspects, Future Challenges |
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| 2010 |
Anja Rathgeb |
Centralised procedure for OTC products: impact on European market and companies *** |
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