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Monday, June 27 • 8:30am - 9:45am
#112: The Upcoming European Clinical Trials Regulation

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Limited Capacity seats available

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

This session will give an opportunity to understand the requirements of the new European Clinical Trial Regulation, the IT developments for its implementation, and to discuss the expectations and preparedness for implementation by global sponsors.

Learning Objectives

Recognize the requirements of the new clinical trial regulation; Discuss major information technology developments required for its implementation; Describe the impact of the regulation for the main stakeholders; Identify the expectations and challenges to be faced by global sponsors.


Anabela Marcal, PharmD


The EU Portal and Database: A Pillar of the Clinical Trial Regulation
Anabela Marcal, PharmD

Getting Ready for the Changes: A Sponsor Perspective
Nick Sykes, MS

Transparency in Clinical Trials: A European Update
Marie-Agnes Heine, MA

avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →

avatar for Marie-Agnes Heine

Marie-Agnes Heine

Head of Communication Department, Stakeholders and Communication Division, European Medicines Agency, European Union
Marie-Agnes Heine is Head of Communication Department at the European Medicines Agency, London. She is a senior external relations and communications specialist with 25 years of experience in communications strategy development and implementation, journalism, advocacy and media campaigns... Read More →
avatar for Nick Sykes

Nick Sykes

Senior Director, Worldwide Regulatory Strategy, Pfizer Ltd.
Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer for 17 years. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation. Previous employment includes SmithKline Beecham, Scrip... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session