| 2015 |
Dr. Andrea Pinsker |
Proposal for a Regulation on Veterinary Medicinal Products in the EU – Comparison to the Existing Legislation and Evaluation of the Differences |
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| 2015 |
Dr. Franziska Pirkl |
The Clinical Development of Disease-Modifying Therapies for Multiple Sclerosis: Critical Overview of the Regulatory Requirements based on the Revised Guideline EMA/CHMP/771815/2011, Rev.2 *** |
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| 2015 |
Dr. Tim Rakemann |
A comparative study of the different approaches for approval of new HIV drugs according to guidelines of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) including possible implications on future drug development *** |
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| 2015 |
Agnès Raust-Sutils |
Changes in an excipient manufacturing location and process - an analysis of regulatory implications *** |
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| 2015 |
Saskia Reßmeyer |
Article 35 referral procedures of Directive 2001/82/EC - Evaluation of Article 35 referral procedures in the years 2001 – 2014 *** |
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| 2015 |
Carolina Rodriguez Beltran |
The Entry of New Oncological Medicinal Products in Colombia Concerning Patient, Government and Industry Interests and How the Quality in the Regulatory Affairs environment Can Be Used as a Tool for Ensuring Access to the Market of Innovative Medicines *** |
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| 2015 |
Dr. Fatemeh Samadi |
Regulatory requirements of medical devices in MENA countries *** |
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| 2015 |
Neha Sanghavi |
Quality by Design in Pharmaceutical Development and Manufacturing |
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| 2015 |
Stefanie Scheffel |
The Process of Implementation of Safety Changes in the Product Information for Medicinal Products nationally authorised in Germany – Responsibilities and Challenges for a Generic Company *** |
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| 2015 |
Reinhold Schilling |
Influence of the 2004/24/EC on the previously marketed Herbal medicinal products within the EU |
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| 2015 |
Dr. Peter Schneider |
Implications of the Revised EMA Clinical Trials Transparency Policy on Industry and Public Healthcare |
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| 2015 |
Dr. Barbara Siebertz |
Patient Registries as Specific Obligations for Marketing Approvals of Orphan Drugs in the European Community *** |
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| 2015 |
Simona Stratil |
Herbal Medicinal Products for Paediatric Population: Analysis of the Status quo in the European Union with Focus on Germany and Approaches to Improve the Situation *** |
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| 2015 |
Dr. Birgit Thome-Kromer |
Consequences of the switch of the intended use of medical devices from human to veterinary use in Germany/Europe *** |
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| 2015 |
PD Dr. med. Nalan Utku |
Usability of data obtained from clinical trials using immunomodulatory drugs in children |
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| 2015 |
Dr. Katharina Veltmann |
Applications for Marketing Authorization and for Registration of Herbal Medicinal Products in the Community - Different Views despite of European Harmonization *** |
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| 2015 |
Dr. Mareille Warnken-Uhlich |
Assessment of Multinational Clinical Trial Aplication within the European Union: Experience and Expectation of the Voluntary Harmonization Procedure *** |
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| 2015 |
Manon Waßmund |
New Conditions in the Pharmaceutical Regulation for Croatia with Accession to the European Union - Preparation, Implementation, Execution *** |
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| 2015 |
Nathalie Welter |
An insight into the post-approval safety surveillance of medicinal products in the three ICH regions (EU, Japan and USA) - with particular focus on the management of safety signals *** |
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| 2015 |
Anja-Simone Wiedemann |
The Impact of Measures Taken by the Federal Institute for Drugs and Medical Devices (BfArM) Regarding the Naming of Medicinal Products from 2010 to 2013 *** |
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