| 2010 |
Anna Geist |
Special consideration of OTC switches with respect to application and national implementation from the generic perspective |
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| 2010 |
Dr. Uwe Goßlar |
What are the prospects for a global "biosimilar"development? Comparison of the regulatory requirements for the marketing authorisation of biosimilar products using the example of implemented or proposed legislation in the EU, Canada, Japan and the proposed WHO guidance |
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| 2010 |
Minna Haapalahti |
Overview of Pathogen Inactivation of Blood Components versus Emerging Pathogens Measures and Implementation Status |
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| 2010 |
Anne-Kathrin Heese |
Submission of variations to implement changes in the product information texts following European Paediatric Work Sharing Procedures according to Article 45/46 of Regulation (EC) No 1901/2006 - from the point of view of a generic company |
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| 2010 |
Thomas Hengelage |
News in nonclinical evaluation of anticancer pharmaceuticals: ICH Guideline S9 and beyond |
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| 2010 |
Dagmar Hintz |
System regulating Medical Devices for Use in Animals |
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| 2010 |
Monika Jung |
Legal uncertainties in European Community legislation regarding data protection |
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| 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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