New post-graduate course on biotech-related regulatory affairs

Specific biopharmaceutical course could facilitate entry into an attractive career

Biopharmaceuticals represent a growing proportion of newly developed medicinal products, so for the first time in Europe, the European Centre of Regulatory Affairs in Freiburg (EUCRAF) is offering a post-graduate course on biotech-related regulatory affairs.

The course focuses on biopharmaceutical-related Regulatory Affairs relevant for European procedures but also offers knowledge on regulations and procedures valid outside the EU. The programme has been developed with the support of health authorities and pharmaceutical companies who have an increasing interest in experts with this distinctive knowledge.

Internationally renowned experts from Health Authorities, the Universities of Freiburg and Strasbourg, the European Directorate for the Quality of Medicines & Healthcare (EDQM) and pharmaceutical and biotechnology companies such as Roche, Pfizer, Cellerix, Novartis and Morphosys will act as course leaders and speakers.

The course consists of nine seminars that can also be booked separately and will take place in Freiburg in Germany and Strasbourg in France. They are offered to graduates or professionals with a degree in pharmacy or medicine or another relevant life science or health subject. The groups are small to allow for an interactive exchange between attendees and speakers.

The course has been devised by Dr Gabriele Schäffner-Dallmann, who has been in charge of antibody-containing medicines at the Paul-Ehrlich-Institut, the German regulatory authority for vaccines and biomedicine, who comments: ‘Biologicals potentially deliver up to 50% of new medicines in the future. They are special and require a particular know-how to be developed successfully.

‘The EUCRAF course provides the necessary know-how and uses practice-orientated didactics. The internationally relevant content is lectured by renowned speakers.’

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