2015 |
Stephan Hurtmanns |
European Union Article 31 referral procedures: a case study on the example of GVK Biosciences |
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2015 |
Katharina Illgen |
Non-human primates in research and safety testing |
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2015 |
Muhammad Zahid Iqbal |
The application of the quality by design approach for the analytical method development in the pharmaceutical industry |
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2015 |
Dr. Helene Kern |
How to develop a fictitious combined ATMP regarding non-clinical and early clinical phase: A possible SME Scenario *** |
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2015 |
Dr. Iris Krugmann |
The Role of Alcohol in Pharmaceutical Products *** |
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2015 |
Lucille Küng |
Phytopharmaceuticals: Analysis of the authorised landscape in the EU and resulting submission
opportunities and challenges from the view of a SME *** |
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2015 |
Lisa Kunzmann |
Interactions between Regulatory Affairs and Pharmacovigilance |
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2015 |
Dr. Christa Lamping |
The Applicability of Scientific Guidelines to Allergens of Biological and Biotechnological Origin - A User Manual *** |
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2015 |
Celine Lentrodt |
The new European Pharmacovigilance Legislation and its impact on the Generics Industry |
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2015 |
Dr. Elke Maneke |
Article 45 EU Worksharing Procedure conducted according to Paediatric Regulation (EC) 1901/2006: What has been accomplished for paediatric use? – A Retrospective Analysis *** |
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2015 |
Markus Meinhard |
The International Generic Drug Regulator Pilot (IGDRP) - A new approach to increase effectiveness in the field of marketing authorisations for generic medicines |
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2015 |
Dr. Maike Melullis |
Best practice of worldwide product variations regarding planning, conduct and implementation *** |
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2015 |
Dr. Madeleine Meusburger |
Die Zulassung von Arzneimitteln im Schweizer Heilmittelgesetz und seine Revision – ein Vergleich mit dem deutschen Arzneimittelgesetz *** |
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2015 |
Caroline Mohr |
Plant made pharmaceuticals (PMPs) as medicinal products for human use - a review of current regulatory issues and challenges to achieve a marketing authorisation in the EU *** |
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2015 |
Dr. Katrin Motejlek |
Pharmacodynamic data submitted for the marketing authorization of biopharmaceuticals in the European Union *** |
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2015 |
Anke Müller |
Regulatory requirements for Transdermal Drug Delivery Systems - A step forward to feasibility and harmonisation? |
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2015 |
Annette Mutschler |
Environmental risk requirements for human medicinal products in the EU: an outlook from an industries' perspective |
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2015 |
Dr. Olga Neumüller |
Factor VIII Concentrates and the AMNOG Early Benefit Assessment - Case Study Turoctocog alfa and Simoctocog alfa *** |
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2015 |
Sven Nisius |
Setting up a Regulatory Intelligence function - A thorough discussion on the process to initiate, develop, implement and maintain a trusted source of regulatory information |
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2015 |
Barbara Petri |
Aesthetic indications: How to bring aesthetic medicinal products to the market? |
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