The subject area Regulatory Affairs ensures that the proof of the quality, safety and efficacy of the medicinal product is demonstrated to be in line with legal requirements for the purposes of marketing safe and efficacious medicinal products solely in the interests of public health.

The unique Seminar Programme "Regulatory Affairs for Biopharmaceuticals including ATMPs" provides with nine Seminars key education in biopharmaceutical-related regulatory affairs. This Seminar Programme also allowing to receive a specialised degree based on the attendance of the whole course is available for the first time in Europe. It meets the requirements of the pharmaceutical industry and of the agencies regulating medicinal products, in particular biopharmaceuticals and advanced therapy medicinal products (ATMPs). It focuses on biopharmaceutical-related Regulatory Affairs relevant for European procedures but also offers knowledge on regulations and procedures valid outside the EU.

The Programme is for individuals who are about to start a career in Regulatory Affairs or who want to continue their training in this special field. The principles of drug development and regulatory affairs 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 Seminar Programme provides this know-how and thus meets current needs of companies developing new biopharmaceuticals and agencies in charge of their authorisation. Both are in need to recruit specifically trained staff due to the increasing role of biopharmaceutical medicinal products.

FACTS

Post-graduate MSc

• One-year programme of 9 Seminars of 2-4 days each (Freiburg, Strasbourg and Langen)
• Can be expanded to 2-3 years
• Pre-reading, Home-work, Case studies, interactive lectures, presentation skills, use of modern communication technique
• Exam for each Seminar, Master Thesis
• Costs: 9000 Euro + VAT (early bird fee) for industry, 7000 Euro + VAT for private persons
• Modern high-quality 4-Star accommodation at attractive costs
• Start: anytime
• New cycle starts each September
• Course language is English

Single Seminars can be booked any time. Company arrangements for Seminar fees are offered.

The Programme focuses on EU but covers the essential details for the systems in US, Japan, Switzerland and other regions such as China.

First-hand expertise is provided by the distinguished speakers of the programme from:

• Health Authorities
• Universities Freiburg and Strasbourg
• European Directorate for the Quality of Medicines & HealthCare (EDQM)
• Global and EU pharmaceutical and biotechnology companies

Innovative training concept

• First-hand experience lectured with focus on practise and cases
• Group work on practically relevant cases
• Interactive discussion
• Development of relevant skills by team work and role play

Study Regulation see here

Entry Regulation see here

Examination Regulation see here