| 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drugs in the light of the new CHMP anti-cancer guideline (CHMP/205/95 Rev. 4 and appendices) and the new FDA draft guidance on expedited programs for serious conditions *** |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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| 2014 |
Dr. Anke Webler-Messenger |
The Company Core Data Sheet: From CIOMS to the implications of the new Pharmacovigilance Legislation *** |
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| 2014 |
Britta Weingarten |
Current drug safety measures for thalidomide and their national implementation in Germany
and the UK *** |
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| 2014 |
Frauke Wellhausen |
Challenges in the regulatory requirements for homeopathic medicinal products in Canada
and the European Union with Germany and Belgium as examples under special
consideration of recent developments *** |
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| 2014 |
Dr. Susanne Weyel-Schnurrer |
Comparative Presentation of the Procedure of Active Substance Master File & Certificate of Suitability and the Implication on the Marketing Authorisation Dossier *** |
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| 2014 |
Dr. Uta Wrackmeyer |
The process of implementing Directive 2010/63/EU into German law |
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| 2014 |
Jing Yuan |
Comparison of Medical Devices Regulations in the EU and the People's Republic of China-Current situation and possible implications of the new Chinese Medical Device Guideline (2014) |
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| 2014 |
Dr. Yuan Zhao |
The regulatory process of electronic submission and its optimization |
|
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| 2013 |
Dr. Heidrun Albrecht |
Experiences with PIPs and their required revisions on the critical path of the development of medicines in indications for adult patients *** |
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| 2013 |
Dr. Martina Arnold |
Better Medicines for Older People - The EMA Geriatric Medicines Strategy |
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| 2013 |
Dr. Fatima Bicane |
Abuse Deterrent Formulation: The new approach to reduce prescription drug abuse in the United States *** |
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| 2013 |
Jochen Bierlein |
Specific requirements of the new Pharmacovigilance legislation on the development and compilation of a dossier for a generic medicinal product (new application and life cycle management acitivities) |
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| 2013 |
Guido Bockler |
The new Directive 2010/63/EU and its implementation in the European Economic Area (EEA): an Overview |
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| 2013 |
Clelia Bonadei |
Obligations of economic operators, traceability, vigilance and market surveillance of medical devices as foreseen by the EU Commission Proposal for a Regulation on Medical Devices of 26 Sept. 2012: comparison with existing requirements and evaluation *** |
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