Regulatory Affairs – esp. Biopharmaceuticals

Organisation:: EUCRAF Ltd.
Ort, Bundesland, Land:: Freiburg, Baden-Württemberg, Germany
Typ:: Part-time
Certificate:: M.B.R.A.
Duration:

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Programme

The Postgraduate Master Course "Regulatory Affairs for Biopharmaceuticals" (RABio) is for individuals who are about to start a career in Regulatory Affairsor or drug development and who have a particular interest in biopharmaceuticals. A new course starts in very September/October but it is possible to start with any seminars.

The regulatory principles applicable to biopharmaceuticals are basically the same as those for common medicinal products. However, various specific requirements are adapted to biopharmaceuticals due to their particular nature. The understanding of these distinct requirements is essential for successful development and authorisation of biopharmaceuticals.

The course provides this know-how and thus meets current needs of companies developing new biopharmaceuticals and of agencies in charge of their authorisation. Both are in need to recruit specifically trained staff due to the increasing role of biopharmaceutical medicinal products.

The programme had been developed by experienced and renowned experts from agencies, the EDQM, companies and universities Strasbourg and Freiburg.

The nine Seminars of the course can be booked individually.

For the Postgraduate Master degree "Regulatory Affairs for Biopharmaceuticals", issued from University Strasbourg, course students attend the lectures, conduct exams and group work on case studies and need to prepare a thesis on a practically relevant topic.

Gabriele Dallmann
Study Director

Target audience

The objective of the practice-oriented, Postgraduate Master Course is to acquire or further develop the expertise and experience required for a Regulatory Affairs professional with focus on biopharmaceuticals.

By participating in the course, while using new media and collaborating in practice-orientated case studies, the attendees will gain expertise and skills enabling themselves to fulfill the role of a Regulatory Affairs’ professional.

Emphases/Curriculum

The lectures are given in 9 thematic Seminars. Seminars, group work and case studies are scheduled in nine organizational blocks for those students who attend the whole course.

Units in Freiburg:

European pharmaceutical regulatory environment
Regulatory procedures valid for:
- Clinical trial applications
- Marketing authorisations
- The life cycle of authorisations
Specific considerations for the development and authorisation of medicinal products for children
Principles of drug discovery and drug development of biopharmaceuticals
Particulars of authorisation of biopharmaceuticals including biosimilars and advanced therapies
Regulatory strategy and health technology assessment to bridge drug discovery and regulatory affairs efficiently
Essential skills of and tools for the Regulatory Affairs professional:
- communication and interaction
- project management
- media tools

Units in Strasbourg:

Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety
The essential characteristics of quality systems

Practical relevance

The selection of course leaders and speakers is very well balanced and solely driven by the intention to provide a course of high quality and practical relevance. Specific didactics help the attendees of the course to learn the scientific armamentarium, but also to develop the practically relevant techniques and soft skills important for a successfully acting Regulatory Affairs' professional. This includes interaction with experts from agencies and companies who give the lectures and case study exercises simulating important aspects of daily work of a Regulatory Affairs' professional.

Admission/Entrance requirements
Part-time:
Number of participants max.:	30
Number of applicants:	n.a.

Fee: The course fee for the attendance in the whole course is 11,000 Euros + German VAT (19%). Early Bird booking rate for the whole course is 9,000 Euros + German VAT (19%) for booking until 31 July 2011. This includes the lectures of all nine Seminars, all lecturing materials, examination registration and participation fees, catering. Entry requirements: Candidates for the Postgraduate Master Course "Regulatory Affairs esp. Biopharmaceuticals" must hold a degree from a recognised institution in either pharmacy or medicine or another relevant life science or health subject. Candidates whose first language is not English must also prove knowledge of written and spoken English sufficient to enable them to undertake the course. Exceptions may be made on an individual case basis. Application: A new course starts in September of each year. Application deadline for the 2011 course is 31 July 2011.

Languages
Language(s) of instruction:	English
Going abroad:	possible

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Miscellaneous:

Organisation

EUCRAF is an initiative of Dr. Gabriele Dallmann, an internationally recognized expert in biopharmaceutical regulatory affairs and ex-regulator of the German Regulatory Agency Paul-Ehrlich-Institut, Prof. Dr. Andreas Bechthold, Pharmaceutical Faculty of University Freiburg, Director of Department Pharmaceutical Biology and Biotechnology and Dr. Gertrud Thormann-Huber, who has unique and long-standing industry expertise in Regulatory Affairs of biopharmaceuticals.

Pharmaceutical industry and agencies continuously need to recruit new staff in Regulatory Affairs and increasingly search for professionals with the distinctive knowledge required to handle biopharmaceuticals adequately.

EUCRAF provides the opportunity of a specialized education in the area of biopharmaceutical-related Regulatory Affairs.

EUCRAF is independent, does not endorse, recommend or privilege particular companies or establishments, products, services, or technologies.

Study in Freiburg

The course will mainly take place in Freiburg, a town in the so-called Tuscany of Germany, located in the Southwest of Germany.

These two cities are located in the three-country-corner France, Germany and Switzerland. Here you find accumulated pharmaceutical industry, research institutions and scientific excellence by the universities Freiburg, Basel and Strasbourg making this area a highly attractive region for life science industry and institutions.