2005 |
Dr. Joachim Gramberg |
Über die Abgrenzungsproblematik bei Repellents *** |
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2005 |
Dr. Markus Hartmann |
Impact of the new legislative framework within the European Union on non-commercial clinical research and investigator-initiated trials: a cross-European analysis with focus on oncology *** |
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2005 |
Dr. Andrea Klüting |
The Effects of the 12th Amendment to the German Pharmaceuticals Act on Clinical Trials in Academic Institutions and the Pharmaceutical Industry *** |
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2005 |
Dr. Daniela Lieder |
Evaluation and consideration of resistance data on the licensing process of antibiotics *** |
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2005 |
Dr. Boris Mey |
Marketing authorisation of medicinal products used to prevent the toxicity of chemical, biological, radiological or nuclear substances (MA of Anti-CBRN Drugs) *** |
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2005 |
Dr. Wolfgang Meyer |
Preclinical and clinical development of anticancer drugs - regulatory peculiarities |
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2005 |
Dr. Rainer Paffenholz |
Nonclinical assessment of immunotoxicity in the EU, United States, and Japan *** |
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2005 |
Dr. Karen Rosenkranz |
Regulatory strategies for life-cycle management of chemical defined cytostatic drugs with regard to the new pharmaceutical legislation *** |
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2005 |
Dr. Sabine Schiemann |
New aspects in comparability studies of biotechnological products subject to changes in the manufacturing process |
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2005 |
Ingrid Schulz |
Comparison of CMC requirements for Clinical Trials in the US and the European Union *** |
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2005 |
Dr. Karin Streso |
Demarcation of medicinal products and food in the European Union - Focus on food supplements *** |
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2005 |
Dr. Michael Sych |
Structure and implementation of an adequate quality assurance system in a pharmaceutical start-up company *** |
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2005 |
Ute Ukelis |
Replacement of In Vivo ATC Studies by In Vitro Cytotoxicity Methods |
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2005 |
Elke Wehres-Losch |
Die Anmeldung klinischer Prüfungen in Deutschland nach der 12. AMG-Novelle Erste Erfahrungen und kritische Aspekte aus Sicht der pharmazeutischen Industrie *** |
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2005 |
Dr. Bernhard Wenkers |
Balancing Regulatory and Economic Aspects in the Development of Generics a Business Case *** |
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2005 |
Dr. Arno Wiehe |
Data protection for the development of known drug substances - Changes with the review of EU legislation *** |
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2005 |
Matthias Wilken |
Empfehlungen zur Erstellung eines Maßnahmeplans unter Anpassung an die aktuellen gesetzlichen Vorgaben unter spezieller Berücksichtigung der 12. AMG-Novelle *** |
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2004 |
Dr. Christine Binninger |
Regulatory standards on clinical trials for medical devices and medicinal products in case of orthopedically used hyaluronic acid |
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2004 |
Dr. Ingeborg Cebulla |
Changes to biological medicinal products (Case Study: Vaccines) *** |
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2004 |
Dr. Ulrike Domack |
Regulatory Science on Orphan Drug Application within Paediatric Field *** |
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