Data Transparency with the EMA:
Monday 11 November 2019, 16:00 - 17:30
Data transparency has been a fast-evolving field since 2013 when the EMA sent out the first draft of Policy 0070 for public review and the EFPIA published the Principles for Responsible Clinical Trial Data Sharing. EMA Policy 0070 Phase 1, focusing on CSRs, has been effective since 1 January 2015 and about 140 Policy 0070 submissions were processed and published before it paused in August 2018 due to Brexit and the resulting EMA business continuity plan.
Health Canada’s equivalent policy has recently been finalised, and effective since 1 April 2019, while the FDA has been conducting pilots with industry to further define their approach to publications of CSRs (still not effective). None of the regulators have yet implemented policies around sharing of Individual Patient Data (IPD), but a number of initiatives (CSDR, Yoda, Project Data Sphere, etc.) have been active for five years or more to support secondary-purpose analyses using IPD based on research requests.
This session will feature a presentation on current efforts from regulators and other organisations to enable data sharing, and a presentation from the EMA on the status of Policy 0070, followed by a Q&A and panel discussion.
If you are unable to attend the entire PHUSE EU Connect (10th - 13th November 2019, €1175), but are interested in participating in this Discussion Club, a one day ticket just for the Monday is available (€595). For more information on the various tickets we have available, read our Registration Overview.
The Monday in particular will feature a keynote speaker, followed by the Real-World Evidence stream for the rest of the day until 4pm when the Discussion Clubs begins. To view the agenda overview click here.
Jean-Marc Ferran, Qualiance
Jean-Marc Ferran is an Independent Consultant based in Copenhagen with more than 15 years of experience in the Life Sciences industry. Prior to starting his company, Qualiance, he worked as a Statistician, Standards Manager and Director of Statistical Programming at Novo Nordisk and Ferring Pharmaceuticals. Jean-Marc also leads the PHUSE Data Transparency Working Group since 2014 and is a member of the EMA Technical Anonymisation Group and Health Canada Stakeholder Reference Group on Public Disclosure of Clinical Documents.
Anne-Sophie Henry-Eude, EMA
Anne-Sophie Henry-Eude is a doctor in pharmacy with post-graduate degrees in Regulatory Affairs and Pharmacovigilance & Pharmacoepidemiology. She worked in the pharma industry then joined EMA as product team leader for anti-infectives. She then worked on paediatric investigation plans in the HIV field. In 2013 she became Head of the new Access to Documents Service and with the implementation of the policy on Clinical Data Publication, she is now Head of Documents Access & Publication at EMA and a member of the EMA Technical Anonymisation Group.