| 2009 |
Josephine Stiebler |
Maintaining compliance with GRP while changing the business process aiming to be able to submit new applications in electronic format (eCTD, paperless) appropriately by end of 2009 |
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| 2009 |
Petra Sulzer |
Requirements for and assessments of medical devices utilising animal tissues and their derivatives *** |
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| 2009 |
Edith Ueberschaer |
Regulatory Requirements for Electronic Expedited Reporting in the European and in the German Legislation with Examples to their Implementation in a Pharmaceutical Company *** |
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| 2009 |
Dr. Rüdiger Vallon |
Regulatory framework for advanced therapy medicinal products (ATMPs) according to the Regulation (EC) No 1394/2007 *** |
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| 2009 |
Dr. Susanne Vambrie |
Regulatory Requirements for the Clinical Development of New Therapies for the Treatment of Alzheimers Disease *** |
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| 2009 |
Dr. Christina Veiel-Fietzek |
Addition of a manufacturing site for a sterile medicinal product (lyophilisate) - Points to consider for transfer of manufacturing process to a contract manufacturer and impact of changes with regard to the registration dossier in the light of the current variation procedure *** |
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| 2009 |
Dr. Corinna Weidt |
A regulatory guidance on achieving and maintaining proof of compliance with an agreed PIP *** |
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| 2009 |
Dr. Kim Wuthold |
Regulatory requirements of the quality of traditional herbal medicinal products and the resulting challenge for the pharmaceutical industry *** |
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| 2009 |
Dr. Karolina Zientek-Lang |
Procedures following the Centralised, Mutual Recognition and Decentralised Procedure in case of a negative outcome of the assessment of the marketing authorisation application. Function of the CHMP and the CMD(h) *** |
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| 2008 |
N´djamawè Bah-Traore |
Drug Safety and Counterfeit Medicines |
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| 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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