| 2011 |
Dr. Liane Söllner |
The need for juvenile animal studies - a critical review *** |
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| 2011 |
Sebastian Strobl |
Counterfeit drugs in industrialized and developing countries - A comparison *** |
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| 2011 |
Dr. Verena Tautorat |
The end of an era: Implementing Variation Directive 2009/53/EC into German Drug Law *** |
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| 2011 |
Dr. Franz Thannberger |
A Step beyond Module 3 of "passive" Transdermal Therapeutic Systems *** |
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| 2011 |
Anja Then-Kania |
Postapproval CMC Changes in the United States with a Focus on Biopharmaceuticals - Current Status and an Outlook in the Pharmaceutical Development *** |
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| 2011 |
Kristina Tripp |
Case Study: Impact of a new German law ("AMNOG") to restructure the pharmaceutical market on a Generic Company |
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| 2011 |
Dr. Alexander Vuia |
First revision of the "Guideline on the Investigation of bioequivalence": BCS-based Biowaiver - opportunities and limitations |
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| 2011 |
Dr. Bettina Walter-Lorenzen |
Improvement of the workflow, quality and effective management of product information texts using a new database |
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| 2011 |
Dr. Günter Waxenecker |
The "Risk Based Approach" - an important tool for managing all the duties in Drug Regulatory Affairs *** |
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| 2011 |
Katrin Wengenroth |
Regulatory Challenges Due to Globalisation of Drug Development and Manufacture Focusing on the Quality of Medicinal Products *** |
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| 2011 |
Dr. Christian Wrehlke |
Development of a database concept for tracking and maintaining regional/country specific Product Information (PI) and PI requirements |
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| 2011 |
Frauke Zeller, (geb. Tuchalski) |
Development of a new medicinal product containing a NCE intended for global marketing taking national regulations and requirements in the MENA region into consideration |
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| 2010 |
Sigrun Adrian |
Die Entwicklung unterschiedlicher Rechtsvorschriften und deren Überwachung im Bereich der Sicherheit von Arzneimitteln und Medizinprodukten in Deutschland (Pharmako- und Medizinproduktevigilanz) |
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| 2010 |
Stanislaus Awrutski |
Drug Regulatory Affairs and Marketing Authorisation in the Post-Soviet countries. Focus: Russia, the Ukraine and Belarus |
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| 2010 |
Dr. med. Maria Ida Behrens |
Chances for children with rare diseases under the Regulation EC 1901/2006 |
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| 2010 |
Viktoria Behse |
Current experience with PIP approvals *** |
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| 2010 |
Dr. Anne Benzinger |
Regulatory requirements for preclinical development of bispecific antibodies *** |
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| 2010 |
Hanna Bölke |
Harmonisation of Product Information Texts of Generic Medicinal Products in EU And its Impact on the Necessity of User Testing and Bridging |
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| 2010 |
Romuald Braun |
White Spots in Document Management in the Life Sciences Industry |
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| 2010 |
Dr. Dieter Brazel |
Regulatory Life Cycle Management of Plasma Protein Therapeutics *** |
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