Jean-Marc Ferran will be presenting on differences and synergies of Data Sharing requirements across agencies on Tuesday 26. February at 11:00-11:30 in Harbor C room:

SA01: EMA, Health Canada and FDA: Three Agencies Tackle Data Sharing. Synergies and Differences

Abstract: The EMA and then Health Canada have respectively launched separate data transparency policies around sharing of Clinical Study Reports (CSRs). The 2 regulators are providing additional guidance to help with implementation of their policies and have each formed stakeholders’ groups.

These two stakeholders’ groups include a variety of professionals and representatives across Life Sciences and focus on topics around data anonymisation, risk of re-identification and data utility while Health Canada’s Reference Group also addresses scope and processes related matters.

This presentation will detail the approaches, goals and achievements of these two stakeholders’ groups and reflect on the EMA and Health Canada’s Data Sharing processes and requirements and where they overlap and differ from each other. In addition, the recent initiative and pilots from the FDA will be discussed. The author will also reflect on their experience participating in both stakeholders’ groups and lessons learned that could benefit other Industry committees.