Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Standalone Modules

Module 10 - Combination Products

Content

Combination products include a combination of a medical device, and/or drug and/or biologic. Module 10 aims to provide participants with knowledge of the regulatory requirements for each component of a combination product including their similarities and differences. The module will additionally provide participants with an understanding of combination product market launch considerations.

Start & Duration

Module 10 starts in March each year.
The completion takes approximately 7 weeks.

Credits

3 ECTS

Fee

The cost of this standalone module is 3'150.– SFr.

Reference

03.010

Module Leaders

Global Head Regulatory Medical Devices, Combination Products & Precision Medicine at Novartis

Mike Wallenstein

Mike Wallenstein Global Head Regulatory Medical Devices, Combination Products & Precision Medicine at Novartis has more than 25 years of experience in various aspects of the MedTech industry.

Founder, Chairman and CEO of confinis ag (Switzerland and USA)

Beat U. Steffen

Beat Steffen, RAC, FRAPS, Founder, Chairman & CEO of confinis ag, (Switzerland and USA) holds a MSc in electrical engineering an executive MBA and has 25+ years of experience in medical device and combination product development/manufacturing/quality management/regulatory affairs. He founded confinis ag in 2005 and co-founded Medical Human Factors AG in 2016, a company specialized in evaluating the use-related safety, effectiveness and usability of medical products.