| 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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| 2010 |
Anna Volodina |
Clinical Studies in Eastern Europe: critical assessment of the regulatory requirements |
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| 2010 |
Dr. Claudia Karin Wagner |
Distribution restrictions (Re-switch of OTC medicines) in Germany and in other selected countries |
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| 2010 |
Sabine Wolf |
European and German Regulatory Requirements to the Design and Validation of Nucleic Acid Tests for Blood Screening |
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| 2010 |
Henny Anna Zietze |
Involvement of Patients and Consumers Organisations (PCOs) in activities of the EMA: Development, implementation and outlook |
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| 2010 |
Dr. Karl Zimmermann |
Die gewerblichen Schutzrechte bei Arzneimitteln in der Europäischen Union und den USA Arzneimittel und Patente |
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| 2010 |
Michael Zlottchenko |
The Quality and Safety Requirements for Vaccines with Emphasis on Viral Vaccines from a Global Point of View |
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| 2009 |
Stephan Becker |
Regulatory Considerations on Drug Interaction Studies |
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| 2009 |
Dr. Claus-Peter Danzer |
Borderline Situations and other important Aspects for the Regulatory Work with Medicinal Products for Oral Care in Europe |
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| 2009 |
Dr. Birgit Dziadek, geb. Kranke |
Generic Substitution of Medicinal Products in the European Economic Area |
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