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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, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, 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)
EMA
Anne-Sophie Henry-Eude, PharmD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department
FDA/CDER: Globalization Perspective
Nancy B. Sager, MBA
FDA, United States
Director, Division of Information Disclosure Policy, ORP, CDER
Health Canada
Andre Molgat, PhD
Health Canada, Canada
Head of Operations, Public Release of Clinical Information
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