| 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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| 2009 |
Christine Kriete |
Peculiarities and Challenges of Herbal Medicinal Products - Assessment of Herbal Medicinal Products within the Regulatory Environments of the European Community and the United States |
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| 2009 |
Dr. Susanne Lange |
The new Variation Regulation. A major step forward? |
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| 2009 |
Dr. Susanne Manhart |
Development of a New Active Substance for Treatment of Alzheimers Disease Development from Preclinical Testing to Proof-of-Concept |
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| 2009 |
Dr. Uta Maucher |
Product Quality Review: New requirements related to medicinal products |
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| 2009 |
Dr. Nicole Max |
Legal proposal to allow pharmaceutical companies to provide information to patients on prescription-only medicines a controversial discussion |
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| 2009 |
Dr. Annette Mayer |
Evaluation and safety assessment of botanical preparations intended for the use in food supplements |
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| 2009 |
Dr. Stephanie Mondabon |
The European Commissions "Pharmaceutical Package": An Analysis |
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| 2009 |
Dr. Christel Neiteler |
Classification Issues on the Borderline between Medical Devices and Medicinal Products - Review of the Current Regulatory Discussions and Decisions |
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| 2009 |
Anna Paulina Paul |
The Polish Pharmaceutical Law Strenghts and Weaknesses 5 Years after Accession to the European Union. Analysis. |
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