| 2007 |
Seval Tangut |
New Regulatory Environment in Turkey |
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| 2007 |
Dr. Dagmar Theis |
Legal Framework for Compassionate Use in the European Union - Comparison of the Implementation of Compassionate Use Programmes by Means of Selected European Member States |
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| 2007 |
Sabine Wägele |
The Global Marketing Authorisation according to Article 6 of Directive 2001/83/EC, as amended |
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| 2007 |
Dr. Nicole Wagner |
International Nonproprietary Names (INNs) - A Critical Issue For Biological Medicinal Products |
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| 2007 |
Dr. Michael Walser |
Analytical Method Validation: Compilation of Relevant Legislation, Guidelines, and Literature |
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| 2007 |
Johanna Walter, (geb. Bleicher) |
The new CMD(h) - a chance for reaching agreement in MRP and DCP? |
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| 2007 |
Martin Watzl |
The New Paediatric Regulation in the EU - Development, Implications and Comparison with US Experiences in Paediatric Drug Development |
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| 2007 |
Tanja Weber |
A Step Beyond Module 3 of Biodegradable Implants |
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| 2007 |
Dr. Tong Zhang |
Audit Check List for Sterile Active Pharmaceutical Ingredients |
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| 2007 |
Dr. Stefan Zwilling |
Monoclonal antibodies developed as anticancer drugs: EU clinical trial application with focus on IMPD requirements |
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| 2006 |
Anne Althoff |
Demarcation of Herbal Borderline Products Medicinal Products or Food Supplements? |
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| 2006 |
Dr. Tatyana Benisheva-Dimitrova |
Challenges For The Pharmaceutical Legislative Implementation In Terms Of An Accelerated Market Access After October 2005 |
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| 2006 |
Dr. Markus Beßeling |
European decentralised procedures for marketing authorisation Differences and similarities between applications of veterinary and human medicinal products |
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| 2006 |
Dr. Reinhard Bogan |
Regulatory requirements for quality management systems in preclinical research and development with special emphasis on the principles of Good Laboratory Practice |
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| 2006 |
Dr. Ursula Bonsmann |
Biowaivers Based on the BCS Only for Class I |
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| 2006 |
Thurid Buch, geb. Fassbender |
The (European) Public Assessment Report as an extended part of the European application procedure - Regulatory background and practical considerations |
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| 2006 |
Dr. Sabine Drechsler |
The re-evaluation regulatory assessment procedure for old herbal medicinal products in Germany, focussing on clinical aspects |
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| 2006 |
Monika Frei |
Parallel import of generic medicinal products - Possible impacts of the Kohlpharma Case |
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| 2006 |
Dr. Hans-Joachim Gamperl |
Drug Risk Management from an Industry Perspective - a Task for the Life Time of a Medicinal Product |
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| 2006 |
Ellen Güttler |
Extended Role of Scientific Advice as a Consequence of the New Medicines Legislation in the EU including a Comparison to the Situation in the USA |
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