Menu Back toSession-1-Access-to-Regulatory-Clinical-Documents-Hear-from-the-Regulators
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Clinical Trial Disclosure and Data Transparency Conference
Session 1: Access to Regulatory Clinical Documents: Hear from the Regulators
Merete Joergensen, MBA, MSc
- Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure
- Novo Nordisk A/S, Denmark
This first session on Access to Regulatory Documents will focus on the regulators’ perspectives while highlighting similarities and differences among the different approaches in EU, US, and Canada. A proactive approach to access to regulatory clinical documents submitted under the centralized procedure has been implemented by EMA’s launch of a specific website. EMA has issued further guidance on the implementation of its Policy 0070 - EMA/240810/2013, and EMA/90915/2016. In March 2017 Health Canada published its intent of a similar approach in the Public release of Clinical Information in Drug Submissions and Medical Device Applications.
Learning Objective :
Anne-Sophie Henry-Eude, PharmD
- Head of Documents Access and Publication Service
- European Medicines Agency, Netherlands
Andre Molgat, PhD
- Head of Operations, Public Release of Clinical Information
- Health Canada, Canada
Nancy B. Sager, MBA
- Director, Division of Information Disclosure Policy, ORP, CDER
- FDA, United States
Q&A Panel Discussion
- All Session Speakers, United States