Regulatory Affairs in Life Sciences
The CAS Regulatory Affairs in Life Sciences will provide you with the necessary tools and skills to enable you to operate in the regulated environment of medical device technology and the pharmaceutical industry.
- Target audience: you are planning to work in a regulated environment in the medical device – or in the pharmaceutical industry.
- This CAS will provide you with knowledge of the regulatory requirements of medical devices, active pharmaceutical ingredients and regulatory requirements for combination products.
- You will be familiar with the objectives of the Swiss Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA).
- You will be familiar with the good manufacturing practices (GMP) for active pharmaceutical ingredients and EU GMP requirements for medicinal drug products.
- Provides you with the knowledge for qualification and classification of medical software (Software as a Medical Device, SaMD).
- Degree/Certificate Certificate of Advanced Studies (CAS)
- Duration calendar week 43 to calendar week 14
- Schedule Friday
- Application deadline One month before the start of the semester
- ECTS credits 12 ECTS-Credits
- Costs CAS: CHF 7500 / Part of a DAS/MAS/EMBA: CHF 6600
- Teaching language German, English
- Location Biel, Aarbergstrasse 46
- School School of Engineering and Computer Science
- Next session Autumn 2023