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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2009 |
Alice Ebel |
Due diligence of R&D projects - A guideline for evaluating regulatory aspects *** |
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2009 |
Dr. Ulrich Feil |
Replacement, Reduction, Refinement of Animal Testing in Quality Control of Medicinal Products in the EU *** |
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2009 |
Sabina Freund-Rieger |
Market Exclusivity versus Market Penetration: Theory and Practice of Originator Generic Competition *** |
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2009 |
Michael Hahn |
Die Auswirkungen der Arzneimittelrabattverträge nach dem GKV-Wettbewerbsstärkungsgesetz auf den deutschen Generikamarkt |
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