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Session 1: Latest developments and future perspectives from regulators on sharing of clinical documents
Session Chair(s)
Merete Joergensen, MBA, MSC
Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark
The COVID-19 pandemic has increased the demand for global access to clinical information. In this session we will hear from regulators from EU, US and Canada on their take of the growing importance of sharing access to clinical documents. What impact the COVID-19 situation might have on the already available processes of clinical document sharing, and plans for the future including considerations for the future process and benefits from global collaboration. What are the pros and cons seen from a regional/country regulatory perspective of an added global collaboration?
Speaker(s)
Anne-Sophie Henry-Eude, PHARMD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
EMA
Nancy B. Sager, MBA
Director, Division of Information Disclosure Policy, ORP, CDER, FDA, United States
FDA/CDER: Globalization Perspective
Andre Molgat, PHD
Head of Operations, Public Release of Clinical Information, Health Canada, Canada
Health Canada
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