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Wednesday, June 21 • 2:00pm - 3:15pm
#341: EMA Policy 0070: A Game Changer for Industry

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Robert Paarlberg, MS

Speaker

EMA Update
Marie-Helene Pinheiro, PharmD

EMA Policy 0070: Insights from the CRO Perspective
Dairine Dempsey, PhD, RPh

EMA Policy 0070: Industry Perspective
Julie G. Holtzople



Moderators
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global re... Read More →

Speakers
avatar for Dairine Dempsey

Dairine Dempsey

Vice President, Strategic Regulatory Affairs, ICON plc.
Dr. Dempsey is VP, Strategic Regulatory Affairs at ICON plc. She is a PhD pharmacist with over 15 years’ experience as a pharmaceutical regulator. She previously held senior positions in the Irish competent authority for medicines where she represented Ireland in the EU & inter... Read More →
JH

Julie Holtzople

Clinical Trial Transparency Operations Director, AstraZeneca
Prior to joining AstraZeneca’s Clinical Trial Transparency Office, Julie worked as a Management Consultant and IT Program Delivery Manager. Today Julie if focused on the end to end implementation of new policies, regulations, tools and the general best practices as they emerge... Read More →
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global re... Read More →
avatar for Marie-Helene Pinheiro

Marie-Helene Pinheiro

Industry Stakeholder Liaison, Corporate Stakeholders Division, European Medicines Agency, European Union
Graduated as Dr. of Pharmacy (1996, Paris). Worked 3 years in Pharma. Industry (Pfizer Central Research, UK) before joining EMA in 1996. Currently Principal Regulatory advisor to CHMP, CAT, VWP, CTWP, EMA ITF & Borderline activities, pandemic strategic group & vaccines & ATMPs RA... Read More →


Wednesday June 21, 2017 2:00pm - 3:15pm
N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616