| 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 *** |
|
|
| 2003 |
Dr. Isabel Schemainda |
EU Enlargement on 1 May 2004: Implications on Existing Marketing Authorizations in the Candidate Countries: Practical Aspects |
|
|
| 2003 |
Nadine Schliecker |
Challenges for the SmPC Harmonisation of Generics in Mutual Recognition *** |
|
|
| 2003 |
Dr. Cornelia Schmidt |
Medicines for Children, a Regulatory Target! |
|
|
| 2003 |
Maren Seip |
Biopharmaceutics Classification System - State of the Art in Development and Practice *** |
|
|
| 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 *** |
|
|
| 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 |
|
|
| 2003 |
Julia Tillkes |
Limits of "Essential Similarity" regarding abridged marketing Authorizations *** |
|
|
| 2003 |
Esther Timm-Kilian |
Development and implementation of measures in a pharmaceutical sales company to deal with drug-related complaints *** |
|
|
| 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 |
|
|
| 2003 |
Dr. Antje Wallstab |
Effective Change Control Management of Product Information Texts *** |
|
|
| 2002 |
Dr. Ulrike Bodesheim |
Review of the European variation regulation and the impact on changes in manufacturing and control of medicinal products *** |
|
|
| 2002 |
Dr. Andrea Derix |
Intellectual Property Rights for Medicinal Products in an Enlarged European Union *** |
|
|
| 2002 |
Gerd Dievenich |
Elektronisches Rezept und elektronischer Gesundheitspass im Rahmen von Telematikentwicklungen in Gesundheitswesen |
|
|
| 2002 |
Peter Frank Eggen |
The Regulation 21 CFR Part 11 and Aspects of Computer Systems Validation for Pharmaceutical Companies *** |
|
|
| 2002 |
Eva Eisenhut |
Comparison of In Vitro Drug Release and In Vivo Data (Bioavailability) of Prolonged Release Oral Dosage Forms - Introduction to Basic Techniques *** |
|
|
| 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 *** |
|
|
| 2002 |
Birgit Haas-Heinrich |
Critical assessment of the stability section of an Ibuprofen sample dossier: relevance from a scientific point of view *** |
|
|
| 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 *** |
|
|
| 2002 |
Dr. Stefan Hock |
Electronic Submissions - The German AMG-Submission Ordinance and its technical implication on the legal environment |
|
|
