Designing, approval and conducting of ATMP clinical trials
A course offered by the National ATMP Research School - 1.5 ECTS
This course is offered by Uppsala University and will provide students with a comprehensive understanding of the design, approval, and conduct of ATMP clinical trials in Sweden, Europe, and internationally.
Course Content:
After completing the course, participants will be familiar with the regulatory framework for clinical studies involving ATMPs in Sweden, internationally and within the EU, and will understand all the steps from a laboratory discovery to an early clinical trial.
Students will learn:
• Which regulatory frameworks apply to clinical trials involving ATMPs and how they differ from other clinical trials
• How to write a clinical trial protocol and what it must include
• Requirements for a "first-in-human" study within ATMP
• Requirements for complying with regulations concerning GMOs
• Requirements for the manufacturing of ATMPs according to GMP (Good Manufacturing Practice)
• How to design a Phase I study for ATMPs regarding doses and toxicity
• How authorities (the Medical Products Agency and the Ethics Review Authority) view applications within ATMP
Course Design
A one-week digital (online) course including lectures and group activities
Course Details
Course Dates:
- The course will be held in week 11, 9-13 March 2026
Course Lecturers:
Gunilla Enblad, professor, Department of Immunology, Uppsala University, and other lecturers.
Host University:
Eligibility Requirements
TBA
Quick Facts:
Dates: Week 11, 9-13 March 2026
Format: Online
Host University: Uppsala University
Registration Deadline: TBA
Contact:
TBA