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EMA Policy 0070: A Game Changer for Industry
Session Chair(s)
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
EMA Policy 0070 is changing how clinical study reports (CSRs) and clinical data summaries are being written. EMA went 'live' with the public website on October 20, 2016, proactively posting CSRs as well as clinical information contained in a Marketing Authorization Application (MMA) following either a positive or negative decision by the CHMP on the MAA. EMA says it expects to publish 4,500 clinical reports per year. In March 2016, EMA published an external guidance on the implementation of Policy 0070. EMA revised the guidance in December 2016 which clarifies the agency’s expectations for the data required for submission. EMEA has stated that this external guidance is a ‘living document’. Phase II of Policy 0070 will include disclosure of Individual Patient Data (IPD).
Join Medical Writing Community for a follow up Round Table discussion at 4:00pm in the Community Corner.
Learning Objective : Identify those areas within an organization impacted by Policy 0070; Discuss approaches companies are taking to comply with the policy; Discuss the challenges of Policy 0070; Describe EMA’s perspective on the external guidance; examine areas where changes will continue to evolve with Policy 0070.
Speaker(s)
EMA Update
Marie-Helene Pinheiro, PHARMD
European Medicines Agency, Netherlands
Industry Stakeholder Liaison, Corporate Stakeholders Department
EMA Policy 0070: Insights from the CRO Perspective
Dairine Dempsey, PHD, RPH
ICON plc., Ireland
Vice President, Strategic Regulatory Affairs
EMA Policy 0070: Industry Perspective
Julie Holtzople
Holtzople Consulting, United States
Independent Consultant