| 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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| 2003 |
Frauke K. Stamm |
The Revision of the European Regulation 2309/93 - Comparison and Assessment of the Draft Version and the Results of the First Reading of the European Parliament |
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| 2003 |
Yuhong Sun |
Variation to marketing authorisations granted for medicinal products in Asia with focus on the Chemical Manufacturing and Control part based on the currently valid EU variation categories |
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| 2003 |
Julia Tillkes |
Limits of "Essential Similarity" regarding abridged marketing Authorizations |
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| 2003 |
Esther Timm-Kilian |
Development and implementation of measures in a pharmaceutical sales company to deal with drug-related complaints |
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| 2003 |
Dr. Adriana Ivanova Vladimirova |
Development of generics during patent protection. Legal and regulatory framework in the EU and North America /USA and Canada/, consequence for the Candidate countries |
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