| 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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| 2003 |
Dr. Beate Hötzl |
Biotechnological generics - a matter of science or science fiction? |
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| 2003 |
Claudia Koritke |
Essential Aspects of Quality Assurance in Outsourcing Production and Purchase of Active Pharmaceutical Ingredients |
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| 2003 |
Rika Kremmer |
Regulatory Enviroment for Traditional Herbal Medicinal Products in the European Union |
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| 2003 |
Dr. Roland Kröger |
Pharmacovigilance Critical Assessment of Current Regulatory Issues with Special Regard to Urgent Safety Restrictions |
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| 2003 |
Dr. Christof Krummeich |
Regulatory and pharmaceutical demands on irradiated medicinal products in Germany and Europe |
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| 2003 |
Dr. Ursula Malter |
Regulatory Requirements for Generic Applications within the EU Chemically Defined Drugs versus Biotechnology-Derived Products |
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| 2003 |
Dr. Anja Mecklenburg |
Strategies for Carcinogenicity Testing of Human Pharmaceuticals |
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| 2003 |
Heike Mödinger |
Variation Procedures of Marketing Authorisations Granted via MRP versus Marketing Authorisations Granted According to National Law in German Speaking Countries (Germany, Austria, Switzerland) Comparison and Discussion of Advantages and Disadvantages |
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| 2003 |
Birgit Moetamedi |
Comparison and assessment of the current EU-Variation Regulations 541/95 and 542/95 and the revised new EU-Variation Regulations 1084/2003 and 1085/2003 |
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| 2003 |
Michael Riesenberger |
Legal and regulatory aspects of manufacturing, quality control and release of 2-[18F]Fluro-2-desoxyglucose ([18F]-FDG) as an example for short-lived radiopharmaceuticals in reflection of relevant regulations, directives and guidelines |
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| 2003 |
Karin Rudolph |
Preparation and realization of variation type I + II in a multinational company with regard to a fictive example (change of manufacturer) in consideration of scientific and administrative aspects |
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| 2003 |
Dr. Isabel Schemainda |
EU Enlargement on 1 May 2004: Implications on Existing Marketing Authorizations in the Candidate Countries: Practical Aspects |
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| 2003 |
Nadine Schliecker |
Challenges for the SmPC Harmonisation of Generics in Mutual Recognition |
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| 2003 |
Dr. Cornelia Schmidt |
Medicines for Children, a Regulatory Target! |
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| 2003 |
Maren Seip |
Biopharmaceutics Classification System - State of the Art in Development and Practice |
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