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Tuesday, June 29 • 10:00am - 11:00am
#219 SL: Advancing Medicines’ Regulation in Europe: Key Strategies to 2025

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-568-L04-P; CME 1.00; IACET 1.00; RN 1.00

The session covers the EMA regulatory science strategy and the European Medicines Agencies network strategy to 2025 and discusses how they contribute to address upcoming innovations and regulatory challenges in view of EU public health priorities. Join the Good Clinical Practices & Quality Assurance Community for a follow up round table discussion (session #251 RT L) on Tuesday, June 29, 3:00PM - 4:00PM EDT.

Learning Objectives

Discuss the importance of having a regulatory science strategy in Europe and the main areas expected to advance medicines’ regulation to 2025; Identify the six strategic focus areas for the European Medicines Agencies Network Strategy (EMAN)to 2025; Describe how the EMAN can help deliver the priorities of the regulatory science strategy (RSS) and of the wider network’s priorities.


Jordi Llinares Garcia, MS


Key Priorities of the European Medicines Agencies Network Strategy (EMANS) 2025
Karl Broich, DrMed

Regulatory Sciences: Leveraging Big Data and Real-World Evidence
Peter Richard Arlett, MD, FFPM, FRCP

Clinical Trial Regulation and Advances in Clinical Trials
Fergus Sweeney, PhD

avatar for Peter Arlett

Peter Arlett

Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Dr Peter Arlett - Head, Data Analytics and Methods Task Force, European Medicines Agency. Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College... Read More →
avatar for Karl Broich

Karl Broich

President, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees. Current research: clinical trials methodology CNS, biomarkers in drug... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Research and Innovation, European Medicines Agency, Netherlands
Dr Jordi Llinares is currently the Head of Research and Innovation at the European Medicines Agency (EMA). At the Agency he has had different posiitons including Head of Orphan Medicines, Scientific Support Development and, and Scientific and regualtory management between 2009 and... Read More →
avatar for Fergus Sweeney

Fergus Sweeney

Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands
Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing... Read More →

Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum
  • Beginner Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking
  • Featured Topics Regulator Thinking
  • Tags Forum