Valérie Salentey
Company: Sensorion
Job title: Director of Regulatory Affairs & Quality Assurance
Seminars:
Chair’s Closing Remarks 4:15 pm
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
Clarifying the Differences in Orphan Drug Designation Between the EMA & FDA 9:30 am
Highlight the key strategic differences between the two bodies for success in gaining Orphan drug designations Explore the main incentives related to Orphan designations Understand the concept of similarity for Orphan drug exclusivityRead more
day: Day Two
Chair’s Opening Remarks 8:50 am
day: Day Two