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Virtual

Nov 16, 2020 3:00 PM - Nov 18, 2020 7:30 PM

(Central Europe Standard Time)

Global Clinical Trial Disclosure & Data Transparency Conference

Session 1: Latest developments and future perspectives from regulators on sharing of clinical documents

Session Chair(s)

Merete  Joergensen, MBA, MSc

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

EMA

Anne-Sophie Henry-Eude, PharmD

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

Nancy B. Sager, MBA

FDA/CDER: Globalization Perspective

Nancy B. Sager, MBA

FDA, United States

Director, Division of Information Disclosure Policy, ORP, CDER

Andre  Molgat, PhD

Health Canada

Andre Molgat, PhD

Health Canada, Canada

Head of Operations, Public Release of Clinical Information

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