Regulatory Affairs Pharma
Pharmaceutical products are developed, manufactured, controlled and distributed in compliance with strict statutory regulations to make sure that they are safe, effective and of high consistent quality. In this CAS you will achieve the key skills to work in this highly regulated environment and learn how to act as a liaison person between companies and regulatory authorities.
- is aimed at people who are planning to work in the field of regulatory affairs in the pharmaceutical industry or who are currently working in the areas of development, manufacturing, quality management or regulatory affairs,
- provides the knowledge to successfully operate in this environment,
- teaches the general framework: structure and function of EU bodies, marketing authorization procedures and legal framework, labelling, GXP, life cycle management.
- Degree/Certificate Certificate of Advanced Studies (CAS)
- Duration Week 43 to week 14
- Application deadline Deadline: One month before the start of the semester
- ECTS credits 12 ECTS credits
- Costs CHF 7500 / as part of a DAS/MAS/EMBA: CHF 6600
- Teaching language English
- Location Bern Wankdorf
- Department Engineering and information technology
- Next session Autumn semester 2021
- You are planning to work in the field of regulatory affairs in the pharmaceutical industry.
- You are currently working in the areas of development, manufacturing, quality management or regulatory affairs and want to improve your knowledge.
- General framework (structure and function of EU bodies, marketing authorization procedures and legal framework, labelling, GXP, life cycle management)
- Clinical development, safety
- Quality (control of drug substance, data requirements and practical guidance, control of medicinal product)
- Market (market access, promotion, parallel import)
- Special regulation for different product classes e.g. biologics, Advanced Therapy Medicinal Products ATMP, blood products
A university degree and practical experience are usually required. People with a high vocational training can apply provided they have sufficient professional experience and prior scientific and methodological knowledge.
Degree + Title
Certificate of Advanced Studies (CAS) in «Regulatory Affairs Pharma»