by Jean-Marc Ferran | Aug 29, 2019 | Blog
What did the FDA put forward to enhance Transparency? Background On 16. January 2018, FDA Commissioner, Scott Gottlieb announced the FDA’s intention to evaluate how they could share Clinical Documents of Pivotal Phase III studies following a successful... 
by Jean-Marc Ferran | Aug 16, 2019 | News
Meet us at the PHUSE Utrecht SDE 2019 on 10 October Jean-Marc Ferran will be presenting with Bjarke Klein (Ferring Pharmaceuticals) on implementing a Life Cycle Management process for programs in LSAF on Thursday, 10 October: Managing Program Development Life... 
by Jean-Marc Ferran | Jun 28, 2019 | Data Anonymisation & Sharing
This presentation features the highlights of a review of 13 academic research reports, with the goal to better understand Data Utility in anonymised CSRs. Their different research purposes have been analysed and classified against the required data to support... 
by Jean-Marc Ferran | May 15, 2019 | News
Meet us at the 6th SAS CTDT Forum 2019 in Heidelberg on 26-27 June Jean-Marc Ferran will be presenting on (1) differences and synergies on Data Sharing requirements across agencies and (2) data utility in anonymised CSRs along with Sarah Nevitt (University of... 
by Jean-Marc Ferran | Apr 15, 2019 | News
Meet us at the PHUSE US CSS 2019 in Silver Spring (MD) on 9-11 June Jean-Marc Ferran will lead the Workshop for the PHUSE Data Transparency Working Group. The following topics will be tackled: Presentations from the FDA and Health Canada on their respective...
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