Lecture Series - Regulatory Science and Translational Research - Part 5

"Interaction with regulators, e.g. in preparation of a first clinical study"

Event information
  •  – 
  • Zoom Video Lecture

Speaker:

Dr. Christian K. Schneider, MD

VP & Chief Medical Officer, Clinical Development Services
PharmaLex Cencora

Part 5:  “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?

 

(The lectures will be held in English)