HTGF Academy

HTGF Academy Online-Workshop: Get ready for first in human studies – what is needed to get approval for testing in humans

04.04.2022 4-6pm CET

Parexel in cooperation with High-Tech Gründerfonds would like to invite you to our workshop “Get ready for first in human studies – what is needed to get approval for testing in humans”.

Date: 06 Apr 2022 4-6pm CET online


  • Introduction of all Subject Matter Experts (SMEs)                approx. 1hour
      • Major pitfalls in early (preclinical) Drug Development- reaching first in human trials
      • “Unbeauty” of accelerated pathways
  • Case Studies
      • Parexel Case Studies
      • Your Case Studies
  • Open discussion

During our 2 hours free of charge virtual session, Parexel’s Subject Matter Experts Dr. Matthias Grossmann (Vice President, Principal Consultant Early Phase),  Simona Stankeviciute (Regulatory Affairs) and Michelle McDonald-Alexis (Principal Regulatory Affairs Consultant) will provide valuable insights in pitfalls and challenges in early (preclinical) Drug Development and accelerated pathways.

Our SMEs will kick off the session providing a 2 case studies.

Participating companies will have the opportunity to layout their development path and being challenged by our experts – similar to  an authorities meeting.

We offer a free 1hour follow-up session with our SMEs for companies presenting their case.

To streamline the needs of our audience and to drill down the topics, we would like to learn more about your Company.

Please take 2 minutes to complete the survey latest by 20 Mar 2022.

We are looking forward meeting with you.


Datum: 04.04.2022
Dauer: 4-6pm CET



Dr. Frank Hensel

Principal / Prokurist