Gene therapy

Let us guide you through the Gene therapy topic and get the necessary knowledge and skills to do it right

  •  Award
  •  180 min workload

This course aims to review the current pharmacovigilance requirements for Gene Therapy

  • Clinical development and long-term follow-up
  • Pharmacovigilance complexities with regard to different type of Gene Therapy as described within FDA guidance
  • Understand EU perspective for development of ATMP
  • High level understanding of ethical consideration

What will you learn

At the end of the course, you will be able to understand the view of the US regulators on Gene Therapy and EMA perspective of the advance therapies. In addition, it will provide you with an understanding on Pharmacovigilance and ethical complexities associated with them.

What’s included

  • Videorecorded lectures
  • Lecture slides and supplemental reading materials
  • Continuous individual progress assessments
  • Final exam quiz
  • Certificate of Completion for the course Gene therapy issued by the Am2P partners

Within which Am2P Certificate

Pharmacovigilance for Biologics

Pharmacovigilance for Biologics

  •  Degree
  •  3 ects
  •  Intermediate

Who made this course

Nasop Experts Group

ISoP's North American chapter
Dr Sepideh Habibi

CRISPR Therapeutics

How does it work

  • Sign up with minimal personal information, or sign in if you already have an account
  • Register to this course immediately and get access for 12 months
  • Follow the different course activities at your own pace
  • At the end of the course, you will pass a final examination and, upon success, you will get a Certificate of Completion for the course Gene therapy!
  • In case of failure, you can review course activities and retake the final examination quizzes, as long as your 12 months active period is on!


Register now and get access to the course for 12 months!

Plan Price
Individual 300 € / 350 $
Groups Please contact us (price discounts based on group size)