Gunilla Enblad

Department of Immuno-oncology, Genetics and Pathology

2026-03-09 -- 2026-03-13

Digital course

5 days

After completing the course, participants will be familiar with the regulatory framework for clinical studies involving ATMPs in Sweden and internationally/EU, and will understand all the steps from a laboratory discovery to an early clinical trial.

• To understand the specific conditions surrounding the conduct of clinical studies within ATMP (Advanced Therapy Medicinal Products): 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

• 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

Not specified

Presentation of group assignement.

Scientific papers in the field according to litterature list.

Gunilla Enblad
Professor in Oncology
Department of immunology, genetics and pathology
gunilla.enblad@igp.uu.se

Erik Yngve
PhD oncology
Akademiska sjukhuset
erik.yngve@igp.uu.se

Course administrator: Marie Pettersson marie.pettersson@igp.uu.se,
Phone: 018-6116324