| 2008 |
Oliver Klaas |
Process validation of a medicinal product: Compilation of relevant legislative, guidelines and literature |
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| 2008 |
Dr. Uta Klöcker |
Marketing authorization of placebos legal requirements and requirements to the dossier in accordance to the German drug law |
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| 2008 |
Dr. Christian Kutzleb |
Comparison of the Regulatory Environment to Authorise so-called Combination Products Consisting of a Drug and a Medical Device in the US and the EU |
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| 2008 |
Dr. Michael Lammers |
Environmental Risk Assessment - Part of the overall Risk / Benefit Assessment of veterinary medicinal products |
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| 2008 |
Dr. Karin Markgraf |
Biosimilars in the EU and in the US |
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| 2008 |
Beate Menkel |
License Application in India with Special Regard to Vaccines |
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| 2008 |
Dr. Beatrix Metzner |
Comparison of marketing authorization procedures for biotechnological products in the European Union (centralized procedure) and in Japan (J-NDA) |
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| 2008 |
Britta Neubauer |
CMC Documentation Contemplation on regulatory requirements in relation to the maintenance of drug products concerning life cycle and change management |
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| 2008 |
Stephanie Pick |
Die Packungsbeilage als Instrument der Verbraucherinformation im Wandel der Zeit |
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| 2008 |
Dr. Tatiana Reimer |
Impact of scientific advice on the outcome of marketing authorisation applications submitted to the CHMP between 2004 and 2007 |
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| 2008 |
Dr. Barbara Römer |
2001/20/EC - A European Directive? Major Regulatory Objectives for a real Harmonisation in Europe |
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| 2008 |
Jörg Schneidereit |
An Approach to Abbreviated New Drug Applications (ANDA) and Question based Review (QbR) |
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| 2008 |
Sandra Schneidereit, (geb. Nehlsen) |
The Escitalopram Case: A Comprehensive Strategy Allowing for Early Market Access of a Generic Drug |
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| 2008 |
Carola Seidel |
Das IQWiG als neuer Eckpfeiler bei der Entscheidungsfindung des Portfolios der Generikaunternehmen |
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| 2008 |
Dr. Patricia Stöhr |
The Regulatory Environment for Vaccine Development - a Challenge for Industry |
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| 2008 |
Florian Strohmaier |
Evaluation of the legal basis of biological and biotechnological product applications in Europe and US and discussion of consequences for similar biological medicinal product applications |
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| 2008 |
Dr. Sanjiv Verma |
The Regulatory Framework concerning the Import of Medicinal Products in India and in the European Union (e.g. Germany) |
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| 2008 |
Dr. Benita von Glahn |
Post marketing Activities in Japan compared to EU and USA |
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| 2008 |
Dr. Martin Wendland |
Regulatory guidance on comparability studies for biological products following changes to the manufacturing process and analytical procedures |
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| 2008 |
Frank Zimmermann |
The Centralised Procedure from the Micro, Small and Medium-sized Enterprise's Perspective and Specific Obstacles of SMEs |
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