| 2014 |
Diana Jung |
Management of Worldwide Regional Regulatory CMC Requirements - An Approach by Creation of a CMC Database |
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| 2014 |
Dr. Johanna Kuhlmann-Gottke |
Regulatory requirements regardings cell-based medicinal products for human and veterinary use in Germany and Europe - a comparison *** |
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| 2014 |
Laura Liekmeier |
Best way to market for generics (DCP or CP) and the limitations due to a multi-brand marketing strategy |
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| 2014 |
Dr. Klaus Löchner |
Inclusion of the German purely national marketing authorisations in the scope of the Variations Regulation and use of the new Classification Guideline of 2013 in practice compared to the previous guideline and the former national German variation system *** |
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| 2014 |
Dr. Tina Lübbehüsen |
Real Time Release Testing - Challenges and Opportunities for the Pharmaceutical Industry |
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| 2014 |
Natalie Lubrich |
Einfluss von DRA auf das Tendergeschäft in Deutschland – Strategien eines mittelständischen Generikaunternehmens |
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| 2014 |
Dr. Sybille Meyer |
Animal Health market in the BRIC countries and comparison of its regulatory requirements for veterinary medicinal products with EU legislation *** |
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| 2014 |
Dr. Margarita Muiños Gimeno |
Regulatory Submission: from paper submissions to RPS *** |
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| 2014 |
Kolmal Musa |
Regulatory Intelligence in the Development of OTC Products *** |
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| 2014 |
Sandra Rauch |
Impact analysis respective the switch from NtA or CTD submissions (paper or NeeS) to eCTD submissions for medicinal products for human use in the EU being newly applied or already authorized– exemplified for Germany (BfArM) *** |
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| 2014 |
Melanie Rosslan |
Regulatory Strategy for an efficient launch of medical devices - a distinct focus on BRICS and MIST countries *** |
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| 2014 |
Nahid Roushanaei |
The New Regulation 536/2014 on Clinical Trials on Medicinal Products for Human Use –
Opportunities and Challenges for European Clinical Research *** |
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| 2014 |
Dr. Anna Schnitger |
The Hospital Exemption, a regulatory option for unauthorised advanced therapy medical products *** |
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| 2014 |
Dr. Alexandra Schubert |
The Regulatory Environment in Nanomedicine: A Comparison between US, EU, Canada and Australia in Assessment of Anticancer-Therapies *** |
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| 2014 |
Dr. Melanie Schüppel |
Educational material as important risk minimisation measure and procedure of agreement with the competent authority *** |
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| 2014 |
Lennart Seidler |
ICH Q3D and related impurities in antibiotics – new requirements for Active Substances in Europe *** |
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| 2014 |
Dr. Awinder Sohal Kauselmann |
Comparison of the labelling processes of human and veterinary medicinal products with an emphasis on the development and post-marketing maintenance activities of labelling |
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| 2014 |
Dr. Stephanie Sommer |
Regulatory acceptability of clinical surrogate endpoints for accelerated (US) or conditional (EU) approval of haematological anti-cancer drugs in the light of the new CHMP anti-cancer guideline (CHMP/205/95 Rev. 4 and appendices) and the new FDA draft guidance on expedited programs for serious conditions *** |
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| 2014 |
Dr. Silvia Specker |
Global Regulatory Registration Plan for a Fixed-dose Combination in the Indication of Hypertension in the European Union, the Unite States of America and selected Emerging Markets *** |
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| 2014 |
Dr. Georg Tschank |
The Impact of the EMA-EUnetHTA Collaboration on Drug Development *** |
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