sitem Center for Translational Medicine and Biomedical Entrepreneurship

Standalone Modules

Module 9 - International Regulatory Affairs

 

Content

Module 9 provides an overview of international regulatory affairs with a particular focus on the US and Asian medical device regulations and path to market.

Learning objectives

Participants gain knowledge about the definition of a combination product, learn about the consequences of MDR and transition timelines and become familiar with the regulatory framework for combination products. They also get an understanding of the types of combination products and learn how to structure a technical documentation for combination products.

Learning content

Module 9 covers an introduction to combination products, the regulation of combination products in the US and EU and changes with the MDR, stakeholders, design controls and technical docu-mentation, general safety and performance requirements for combination products, and risk management for combination products. 
It also includes regulatory requirements for devices containing an ancillary medical product versus drug delivery devices, human factors and usability engineering for combination products, and lastly post-market surveillance (Pharmacovigilance versus Materio-vigilance).

Start & Duration

2020: 21 October 2021
2021: TBC

The completion of this module takes approximately 7 weeks.

Credits

2 ECTS

Fee

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

Reference

03.009

 

Module Leaders

Co-Founder and VP at confinis Corp (US) - Senior Consultant at confinis ag and med-HF (Switzerland)

Viky Verna

Co-Founder and VP at confinis Corp (US), and Senior Consultant at confinis ag and med-HF (Switzerland), providing regulatory affairs services to the medical device and pharmaceutical industries. Qualification supported by 10 years of experience in the field, including 6 years working at the US Food and Drug Administration (FDA - ORA and CDRH), and a solid education with a MS in Biomedical Engineering, MS in Pharmacy, Regulatory Affairs Certificate, and a Regulatory Affairs Certification (RAC Global).

Regulatory Consultant, confinis ag

Cherry Marty