Biopharmaceuticals (includes Biologics)
This is a current topic that all CROs, Global Sponsors of clinical trials and Global Regulatory Managers are dealing with. The session will discuss the history of regulations in this area, key differences based on regional requirements, the growing trend in reliance on global clinical data for marketing authorizations and case studies that have led to successful strategies in global clinical development. This session will also include possible approaches taken by different Sponsors that will serve as learning points for clinical operations, planning, and regulatory professionals. The trend shows that more European countries are going to hop on to the wagon of not conforming to US-based regulation and this could result in a planning nightmare for global Sponsors. Highlighting the difficulties and brainstorming/resolving this issue proactively is of utmost importance.