sitem Center for Translational Medicine and Biomedical Entrepreneurship

Translational Medicine and Biomedical Entrepreneurship

Module 4 - Regulatory Affairs

 

Content

The role of the different regulatory authorities along the translational pathway and the product specific requirements are presented.

Learning objectives

After this module, participants understand the legal framework and elements relevant for the registration of biomedical products. They also know about new and innovative regulatory processes and have learned about strategic planning of regulatory activities.

Learning content

Regulatory Affairs covers the legal framework for drugs and medical devices, the regulation of drugs, the certification of medical devices and diagnostic tools, and the regulation of particular medical products, such as orphan drugs. 
The module further contains the regulation of combination products and pharmacovigliance and materiovigliance.

Lecturers

Various experts from industry, such as meditec Consulting and PhACT, academia and public institutions including the University of Basel and World Health Organization.

Start & Duration

2020: 8 September 2021
2021: TBC

The completion of this module takes approximately 9 weeks.

Credits

5 ECTS

Fee

The cost of this standalone module is 5250.– SFr.

Reference

01.004

 

Module Leaders

Senior Drug Regulatory Affairs Expert and Managing Director of Phact GmbH

Dr. Barbara Jentges

Barbara is a Senior Drug Regulatory Affairs Expert with more than 28 years of experience in the area of Drug Regulatory Affairs. Her professional focus is on supporting companies in developing optimal registration strategies for their newly developed medicinal drug products. Special attention is given to support the implementation of science-and risk-based principles according to ICH Q8 to Q11.

Founder of meditec Consulting

Sandra Soniec

Sandra Soniec holds a degree in Biomedical engineering and has 20+ experience in the healthcare and life sciences regulatory environment, providing technical and expert support to start-ups and global players. In 2004, Sandra founded meditec Consulting, a consulting firm providing regulatory affairs and quality affairs services and solutions with focus on medical devices, in vitro diagnostics and combination products.