| 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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| 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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