Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Walter E. Washington Convention Center

Jun 14, 2015 9:00 AM - Jun 14, 2015 5:00 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

#45: The Good Pharmacovigilance Practices in the EU: Global Applications

Speakers

Peter Richard Arlett, MD, FFPM, FRCP

Peter Richard Arlett, MD, FFPM, FRCP

Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

Saad  Shakir, DrMed, MD, FFPM, FISPE, FRCP

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Director, Drug Safety Research Unit, United Kingdom

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is a service provider and associate department of the University of Portsmouth. At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations. He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.

Steve  Jolley, MA

Steve Jolley, MA

Chief Executive Officer, SJ Pharma Consulting, LLC, United States

Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events. Steve has 30 years’ experience in drug safety and pharmacovigilance and has worked with over 100 clients in North America, Europe, Japan, India and China. He holds degrees in mathematics and computer science from Cambridge University, England. He is an Adjunct Professor at Rutgers University and teaches part of their Master’s degree in Drug Safety and Pharmacovigilance.

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.