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Session 6: Challenges of Non-Interventional Study Disclosure
Session Chair(s)
Kathleen Ormiston, MS
Global Head of Trial Transparency
Sanofi US Inc, United States
With increasing focus on real world evidence from non-interventional studies for regulatory decision-making, should organizations disclose their non-interventional studies beyond the current requirements and if so, which ones? This session will share the experience of 2 pharma companies in setting up and implementing processes for systematic non-interventional study disclosure. Challenges in visioning and operationalizing the work will be explored, as well as current trends on the disclosure landscape. Solutions and insights based on disclosing a range of non-interventional study categories, global and local, will be highlighted, with Q&A at the end of the session
Speaker(s)
Overview of Non-Interventional Study Disclosure
Kathleen Ormiston, MS
Sanofi US Inc, United States
Global Head of Trial Transparency
Operationalizing Non-Interventional Study Disclosure Within a Company - Sanofi
Ranjita Mishra, MA, MSc
Sanofi US, United States
Trial Transparency Senior Manager
Operationalizing Non-Interventional Study Disclosure Within a Company - GSK
Priya Pavithran, MSc
GSK, Belgium
Senior Director, Head - Clinical Trial Transparency and Data Sharing