| 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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| 2003 |
Dr. Antje Wallstab |
Effective Change Control Management of Product Information Texts |
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| 2002 |
Dr. Ulrike Bodesheim |
Review of the European variation regulation and the impact on changes in manufacturing and control of medicinal products |
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|
| 2002 |
Dr. Andrea Derix |
Intellectual Property Rights for Medicinal Products in an Enlarged European Union |
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|
| 2002 |
Gerd Dievenich |
Elektronisches Rezept und elektronischer Gesundheitspass im Rahmen von Telematikentwicklungen in Gesundheitswesen |
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|
| 2002 |
Peter Frank Eggen |
The Regulation 21 CFR Part 11 and Aspects of Computer Systems Validation for Pharmaceutical Companies |
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| 2002 |
Eva Eisenhut |
Comparison of In Vitro Drug Release and In Vivo Data (Bioavailability) of Prolonged Release Oral Dosage Forms - Introduction to Basic Techniques |
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| 2002 |
Doris Göllner |
The organisation of a mutual recognition procedure by a pharma consulting company with Germany as RMS and all other EU member states including Norway and Iceland as CMS - experience and suggestions for practical implementation |
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| 2002 |
Birgit Haas-Heinrich |
Critical assessment of the stability section of an Ibuprofen sample dossier: relevance from a scientific point of view |
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| 2002 |
Tanja Heinrich |
A Regulatory Guide through Mutual Recognition Procedure for a Medicinal Product, Germany acting as concerned Member State from a German Drug Regulatory Affairs Manager's point of view |
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| 2002 |
Dr. Stefan Hock |
Electronic Submissions - The German AMG-Submission Ordinance and its technical implication on the legal environment |
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| 2002 |
Miriam Hoffmann |
Advantages and disadvantages of the changes intended in the "Review 2001" with regard to Renewals of Marketing Authorisations and the impact on post-marketing surveillance |
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| 2002 |
Wolfram D. Hummel |
Quality Management Systems (QMS) in the Context of Planning for and Controlling the Quality of Drugs |
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| 2002 |
Uta Kästner |
Arzneimittelsicherheit Aut-idem eine Gratwanderung zwischen therapeutischem Anspruch und finanziellen Zwängen |
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| 2002 |
Dr. Christian Krezdorn |
Project Report on: Theory and Reality of Multiple Applications in National Procedure, MRP and CP Demonstrated by Practical Case Reports |
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| 2002 |
Dr. Angelika Leinweber |
Regulatory Requirements concerning Process Validation: Differentiation of the Requirements for Registration Purpose in Comparison with the Requirements according to GMP |
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| 2002 |
Patricia Lüer |
Alternative methods for animal testing in the drug regulatory environment |
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| 2002 |
Dr. Hans-Jürgen Mika |
GMP Relating to Medicinal Products - Quality Instrument or Regulatory Burden |
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