| 2004 |
Dr. Wolfgang Meder |
Rx-to-OTC Switch - Opportunities And Risks With Focus On Statins |
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| 2004 |
Viraj Mehta |
Trade Related Aspects of Intellectual Property Rights and Pharmaceuticals: The Impact of Extended Protection on India |
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| 2004 |
Monika Merfels |
The new regulatory framework for authorisation and reevaluation of feed additives by the European Food Safety Authority in the European Union |
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| 2004 |
Bettina Missner |
National and International Information Exchange through Vigilance Reports |
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| 2004 |
Dr. Ursula Moosbauer |
The Impact of Stereoisomerism on the Regulation Procedure on the Example of Antibiotics |
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| 2004 |
Barbara Ost |
Accreditation of a control laboratory for testing of medicinal products |
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| 2004 |
Dr. Beate Preuss |
Quality related changes during the life-cycle of a medicinal product marketed in the EU and their impact on the pharmaceutical documentation (CTD module 3) |
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| 2004 |
Dr. Jan Richter |
Scientific and regulatory concepts for the development of molecular targeted anti-cancer drugs |
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| 2004 |
Anja Kirsten Schiefer |
Comparison of the requirements in the registration and marketing authorisation procedure of human homoeopathic medicinal products within the EU with regard to specific requirements in Germany, Austria, the Netherlands and Switzerland as a Non-EU-country |
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| 2004 |
Dr. Elmar Hermann Schmitt |
Regulatory background in the development of medicinal products for human use produced by transgenic animals - current situation in the EU and USA |
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| 2004 |
Heike Strutzenberger |
The regulatory requirements of EU-Directive 2001/20/EC and transposition into national legislation of the Member States |
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| 2004 |
Verena Stumpf |
Switch from CFC-containing to CFC-free metered dose inhalers - current status and regulatory aspects |
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| 2003 |
Dr. Robert Alz |
Antimicrobial Drug Resistance - Impact on the Pre- and Postlicensing Process of Veterinary Medicinal Products in the European Community |
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| 2003 |
Sandra Baghestani, geb. Strohhöfer |
Generic applications in the EU and in the USA - a comparison |
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| 2003 |
Dr. Christine Bautz |
The legal status of medicinal products: Potential problems arising in case of a compulsory harmonisation as discussed in the current revision of the EU legislation |
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| 2003 |
Dr. Michael Berntgen |
Exploring Paediatric Indications for Off-patent Drug Substances - Strategic Input of Regulatory Affairs |
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| 2003 |
Loneliese Canali |
The different regulatory requirements for conducting clinical trials in the EU and the consequences for multinational studies. How will these procedures be changed by implementation of the Clinical Trial Directive 2001/20/EC? |
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| 2003 |
Leonor Enes |
A comparative study of generic medicinal products in Europe |
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| 2003 |
Veronika Etges |
CMC - Variation in a Globally Operating Pharmaceutical Company |
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| 2003 |
Dr. Kirsten Hiebenthal-Millow |
Test procedures in the specifications for herbal medicinal products according to CPMP / CVMP-guidelines compared with those for chemically defined medicinal products |
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