ATMP Regulatory Affairs

Standalone Module - Spring 2026 - 3 ETCS - CHF 3'150

  

This module is held in collaboration with Swissmedic and gives an overview of different ATMP modalities and their regulatory aspects with respect to clinical trials and market authorization. It provides a basic introduction to ATMP related technologies as well as scientific and clinical aspects. This module is offered in collaboration with Swissmedic and knowledge is provided by experts specialized in inspection, quality, pre-clinical, clinical and post-marketing.

Learning objectives

  • You understand the basic science behind most common ATMP-related modalities such as cell therapies and gene therapies and tissue engineering products,
  • You are able to position the legislation and the regulatory processes of ATMP within the medicinal drug products regulation,
  • You can navigate in the classification of ATMP and distinguish those products from other medicinal drug products,
  • You are able to better appreciate the expectations of regulatory authorities for ATMP from first-in-human clinical trials to marketing authorizations,
  • You foresee regulatory solutions for future regulatory ATMP application based on real-world examples,
  • You are enabled to anticipate the new product developments in the field of ATMP such as CRISPR-Cas technologies.

Scope & duration

3 ECTS points
This is equivalent to roughly 75-90 working hours

Start

The module takes place in spring term each year.

📍On-site events take place at sitem-insel in Bern, Switzerland.

Please feel free to contact the School if you have any more detailed questions. 

Fee

This module can be attended as single course at a fee of CHF 3'150.-
👉 Contact the School if you are interested in this module as a single course.

Head of the Swissmedic ATMP Unit 3

PD Dr. Andreas Marti

Andreas Marti is head of the Swissmedic ATMP Unit 3 (nonclinical / clinical assessment) and he has more than 20 years of experience in the field of cell and gene therapy regulation. In addition to his tasks at Swissmedic, Andreas Marti is also a docent at the Institute of Cell Biology (University of Bern).

Nonclinical assessor in the ATMP division at Swissmedic

Michel Hauser

Michel Hauser is a nonclinical assessor in the ATMP division at Swissmedic, contributing to the review of clinical trial submissions and marketing authorization applications for advanced therapy medicinal products. His work centers on analyzing pharmacodynamics, pharmacokinetics, and toxicology data. In addition, he offers nonclinical and regulatory guidance to ATMP developers through the Swissmedic Innovation Office.