5th Lecture 18-05-2017

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?