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REGULATORY STRATEGIES AND PRACTICAL …
REGULATORY STRATEGIES AND PRACTICAL ASPECTS FOR THE DEVELOPMENT AND AUTHORISATION OF ORPHAN medicinal PRODUCTS IN THE EUROPEAN UNION Wissenschaftliche Pr fungsarbeit zur Erlangung des Titels Master of Drug REGULATORY Affairs der Mathematisch-Naturwissenschaftlichen Fakult t der Rheinischen Friedrich-Wilhelms-Universit t Bonn vorgelegt von Dr. Matthias Dormeyer aus Hagen Bonn 2008 - 2 - Betreuer und 1. Referent: Markus Ambrosius Zweiter Referent: Dr. Rembert Elbers - 3 - Experiences after more than 500 orphan medicinal product designations and nearly 50 authorized orphan drugs. - 4 -TABLE OF CONTENTS ABBREVIATIONS .. - 7 - - 9 - - 11 - GENERAL - 11 - Requirements for Orphan medicinal Product - 11 - Orphan Condition and Orphan medicinal Products .. - 11 - Pros and Cons for Orphan Drug Designation.
regulatory strategies and practical aspects for the development and authorisation of orphan medicinal products in the european union wissenschaftliche prüfungsarbeit
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Investigational, Investigational medicinal, Medicinal, Guideline, INVESTIGATIONAL MEDICINAL PRODUCT, INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER FOR, Investigational Medicinal Products IMP, Clinical development of medicinal products intended, TO ICH E11: CLINICAL INVESTIGATION, TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL