| 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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| 2009 |
Dr. Frauke Hätzelt |
Vitamins as Medicinal Products Regulatory Considerations *** |
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| 2009 |
Dr. Thorsten Henning |
Rx-to-OTC switch Comparison of the Current Regulatory Approaches in Germany, in the UK, and in the USA *** |
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| 2009 |
Viola Hieble-Gerhard |
Risk-based management of GMP audits within the context of supplier relationships an approach for a medium-sized pharmaceutical company *** |
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| 2009 |
Dr. Angelika Hönlinger |
Referral procedures Overview, analysis and outlook *** |
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| 2009 |
Dr. Detelina Ivanova |
PDCO one year experience of the paediatric regulation |
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| 2009 |
Houmyra Kazimie |
European and national (German) databases with regard to clinical trials involving children |
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| 2009 |
Claudia Keupp |
Portfolio strategies of cytotoxic drugs current topics of regulatory economy *** |
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