5th Lecture 18-05-2017
Title: "Interaction with regulators, e.g. in preparation of a first clinical study"
- What are the possibilities?
- How does one plan this interaction optimally? What to do as an academic group?
- Which special possibilities does one have when developing „Advanced Therapies“ (gene therapies, cell therapies, tissue engineering products)?
- From practice: How does a Scientific Advice meeting with regulators look like? What happens there? How to prepare?