Amanda Rivière

Company: Genethon

Job title: Manager Regulatory Affairs

Seminars:

Case Study: Navigating Temporary Halts Through a Collaborative Approach Between Sponsors 10:00 am

Discuss the challenges presented with temporary halts on gene therapy clinical trials How to successfully co-operate with regulatory agencies to renew proceedings What impacts do these halts have on the patient rare disease community? A collaborative approach: A mechanism to mitigate risks in gene therapy development programmesRead more

day: Day Two

Roundtable: Insight on Case-by-Case Reviews of Various Regulatory Submissions 1:00 pm

There are currently over 209 companies in Europe developing regenerative medicines and ATMPs. In lieu of this however, there are only 11 EMA-approved gene therapies in the market. To gain an insight into best practices navigating regulatory hurdles during various stages of the gene therapy development process, we will dive deeper into some gene therapy…Read more

day: Day Two