Meet us at the
PHUSE US Connect 2019 in Baltimore on 24-27 February
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.
When & Where
The PHUSE US Connect 2019 conference will take place in Baltimore on 24-27 July 2019.
Date: 24-27 February 2019
Location: Baltimore Marriott Waterfront Hotel
Event Website: PHUSE US CONNECT 2019
US PHUSE Connect 2019
GET IN TOUCH
Please get in touch if you would like to meet at this occasion to discuss your projects!
OUR LATEST NEWS
Meet us at the PHUSE US Connect 2020 in Orlando on 8-11 March Jean-Marc Ferran will be presenting with Paul Vervuren (Danone Nutricia Research) on approaches and lessons learned from a recent LSAF implementation at Danone Nutricia Research: Migrating to LSAF –...
Meet us at the CBI Clinical Data Disclosure Conference 2020 in Coral Gables (FL) on 22-24 January Jean-Marc Ferran will be presenting on (1) differences and synergies on Data Sharing requirements across agencies and (2) data utility in anonymised CSRs: EMA, Health...
Meet us at the PHUSE EU Connect 2019 in Amsterdam on 10-13 November Jean-Marc Ferran will be presenting with Paul Vervuren (Danone Nutricia Research) on approaches and lessons learned from a recent LSAF implementation at Danone Nutricia Research on Tuesday 12....