This program provides the essential education in biopharmaceutical-related regulatory affairs. It meets the requirements of the pharmaceutical industry and of the agencies regulating medicinal products, in particular biopharmaceuticals and advanced therapy medicinal products (ATMPs). They are in need to recruit specifically trained staff due to the increasing role of biopharmaceutical medicinal products including ATMPs and biosimilars. The program provides knowledge on the European procedures but also on regulations and procedures of other regions of the world such as USA, Japan, Switzerland, China.
Lecturers are distinguished experts from health authorities, from the Universities of Strasbourg and Freiburg, from the European Directorate for the Quality of Medicines (EDQM) and from global and local pharmaceutical and biotechnology companies.
The lectures impart relevant knowledge, case studies are presented and discussed and interactive presentations allow the attendees to comment and discuss. By this the course is very lively, the participants benefit from the exchange between the group and the speakers. Presentation techniques are also trained as the results of the group work on case studies or home work are presented as part of the course.
Parcours : Regulatory Affairs for Biopharmaceuticals
The program is for both,
* MSc graduates in pharmacy, biology, biochemistry, medicine, biotechnology, who wish to start a career in Regulatory Affairs
* Pharmacy MSc students who want to take some of the seminars as part of their MSc degree
An application is to be sent to EUCRAF, all details on the documents to be submitted can be found on the website http://www.eucraf.eu. The Scientific Course Committee decides on the approval to participate.
10 seminars of 2 to 4 days with one additional day, i.e. Saturday, for group work, case studies and exam. Can be started any time.
1. European pharmaceutical regulatory environment (September 2016)
2. Regulatory procedures for clinical trial applications, marketing authorisations, variations in the EU, USA, Japan, Switzerland and China (December 2016)
3. Registration of blood products, vaccines and ATMPs (March 2017)
4.1. Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier (May 2017)
4.2. Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements (2017)
5. Paediatrics, specific considerations for the development of medicinal products for children (December 2017)
6. Pharmacovigilance - Post-authorisation surveillance standards to meet regulatory requirements for product safety (Febuary 2018)
7. The roles of the supervising authorities and the essential characteristics of quality systems (May 2018)
8. Scientific advice, regulatory strategy and health technology assessment (July 2018)
9. Good regulatory affairs practice: communication skills, project management and tools for the daily practise (October 2018)
This training course is an « action d'adaptation et de développement des compétences » (ref. French law). A certificate of attendance is delivered after the course. An evaluation measures the trainees' satisfaction and the achievement of learning objectives.
M. Jean-Yves Pabst, Professor at the Faculty of Pharmacy Strasbourg
Mme Gabriele Dallmann, PhD, Biopharmaceutical expert, EUCRAF Munich, Germany
10 modules de 2 à 4 jours au rythme choisi par le candidat
En 2016/2017 :
Référence : FCS17-0684
FREIBURG and MÜNICH, GERMANY
Possibility of reduction for individual or academics (please contact us)
Contact EUCRAF (European Centre for Regulatory Affairs):
Phone: +49 (0)761 13734424
Fax: +49 (0)761 1373444
(+German VAT, 19%)
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