Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Harmonisation of the Quality Dossier by Means of the Worksharing Procedure: A Look at Execution and Advocacy from Applicant's Perspective ***

Alexander Dziambor (Abschlußjahr: 2020)

Summary
Language: English
In this thesis an overview is given on the subject of worksharing and the voluntary harmonisation of Module 3 of nationally authorised medicinal products.
It not only focuses on the question of the execution and the advocacy of the method, but also addresses the question why not more worksharing is conducted by the pharmaceutical industry.
The thesis presents a detailed legal background, recent statistics on worksharing, the decision-making process, pre-submission activities, the step-by-step execution of the procedure, the post-authorisation phase as well as an analysis of procedural fees and national approvals.
in order to ascertain the experiences of pharmaceutical companies with the conduction of worksharing in general and Module 3 harmonisation in particular, an online questionnaire was created and distributed with the help of the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie, BPI). The results are evaluated graphically as well as compared by company size, number of marketing authorisations and location of headquarters.
The results are discussed and amended by other points to consider when applying for an alignment of the quality dossier. Suggestions for improvement are also provided that may prove to be helpful when in doubt before and during the procedure.
This thesis may help to guide marketing authorisation holders that want to apply for a harmonisation of Module 3 but are not yet familiar with the procedure or for applicants that wish to know what the advantages and obstacles are.
Pages: 76