| 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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| 2010 |
Syed Irshad Rizvi |
Influenza A (H1N1) - a new communicable disease Role and activities of the Health Authorities and International Organizations in relation to the current H1N1 influenza pandemic *** |
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| 2010 |
Dr. Johanna Roggemann |
An overview on the requirements for the acceptability of invented names for human medicinal products in the Centralised Procedure *** |
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| 2010 |
Dr. Christiane Rothkegel |
Impact of Clinical Trial Registration on the Future of Drug Research *** |
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| 2010 |
Ridwan Sarwin |
Assessment of the new EU variation regulation No 1234/2008/EC on the practicality aspects for post-approval changes of human medicinal products |
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| 2010 |
Dr. Erik Schneider |
Determination and comparison of the regulatory requirements of human recombinant antibodies, Fab-fragments and aptamers regarding product and manufacturing quality |
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| 2010 |
Dr. Stephanie Schwarz |
Make off-patent drugs available to children: Regulatory approaches in Europe and the US *** |
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| 2010 |
Dr. Dietmar Theisen |
European Regulatory Framework of Stem Cell-based Medicinal Products *** |
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