| 2008 |
Dr. Edda Ballweber |
In vitro equivalence criteria of orally inhaled products (OIPs) and role of in vitro data in the overall therapeutic equivalence program - A comparison between Europe, Canada and the U.S. |
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| 2008 |
Mariela Becker |
Experiences with the New Decentralised Procedure Changes, Limits, Perspectives |
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| 2008 |
Ines Becker-Schnoor |
Sunset Clause- Implementation within the EU and its influence on regulatory strategies |
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| 2008 |
Dr. Ursula Beikert, (geb. Tammler) |
REACH How does it affect the pharmaceutical industry? Consideration of the issue for a medium-sized enterprise |
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| 2008 |
Dr. Janina Julia Bielefeldt |
Evaluierung der deutschen und europäischen Rechtsprechung hinsichtlich des Risikos für Arzneimittelfälschungen |
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| 2008 |
Rainer Brunschier |
Generic Drug Submissions in Japan from a Global Players Point of View |
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| 2008 |
Dr. Matthias Dormeyer |
Regulatory Strategies and Practical Aspects for the Development and Authorisation of Orphan Medicinal Products in the European Union |
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| 2008 |
Dr. Theodore L. Drell IV |
Defining the regulatory strategy for the rapid implementation of a multinational, global clinical trial in an oncological indication |
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| 2008 |
Bettina Geng |
"Die Nachzulassung" Legal requirements and regulations regarding the pharmaceutical quality of medicinal products from the notification of 1978 until today |
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| 2008 |
Dr. Christine Gillen |
Could the Global Harmonization Task Force guidance of a standardized harmonized documentation format succeed in global harmonization? |
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| 2008 |
Dr. Derk Eldert Görich |
One Step beyond the eCTD: Update of the Dossier by electronic Variations In Europe and Germany |
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| 2008 |
Dr. Andreas Grummann |
Strengthening and Rationalising the European Pharmacovigilance System |
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| 2008 |
Nadine Herzog |
Optimisation of Master File Procedures for Biologics: Comparison of Master File Procedures - EU and USA |
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| 2008 |
Dr. Monika Hitzl |
Global regulatory requirements and how to reflect them in the process control system of pharmaceutical industry - Implementation of Process Analytical Technology |
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| 2008 |
Heli Hulkkonen |
Generic Medicinal Products A Comparison of Regulatory Framework between Germany and Finland |
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| 2008 |
Susanne Igl |
Quality of Medical Devices Incorporating a Medicinal Substance Having Ancillary Action in the EU Requirements According to Medical Device Regulations and According to Medicinal Products Regulations |
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| 2008 |
Rita Jochum |
Necessity of consultation procedures on medical devices incorporating a medicinal substance |
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| 2008 |
Dr. Astrid Kaufmann |
Is Readability Testing an adequate procedure to improve the legibility of package leaflets? A European comparison including German and British liability aspects |
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| 2008 |
Saskia Kissel |
Gibt es eine Zukunft für die Standardzulassung in Deutschland? |
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| 2008 |
Petra Kist |
Pharma-Mittelstand - Drug Regulatory Affairs Portfoliostrategie |
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