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

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.