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Walter E. Washington Convention Center

2015 年 06 月 14 日 9:00 上午 - 2015 年 06 月 14 日 5:00 下午

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

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

讲演嘉宾

Peter Richard Arlett, MD, FFPM, FRCP

Peter Richard Arlett, MD, FFPM, FRCP

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

Dr. Peter Arlett leads the Data Analytics and Methods Taskforce at the European Medicines Agency (EMA), overseeing clinical evidence, real-world data, AI, and safety reporting. He chairs the EMA Data Board and co-chairs several key groups, including the HMA-EMA Big Data Steering Group and the Vaccine Monitoring Platform. Before joining EMA in 2008, Dr. Arlett worked at the European Commission, served as a UK delegate to the European Committee for Human Medicinal Products, and held roles at the MHRA. He trained as a physician in Oxford and London, holds a medical degree from University College London, and is Honorary Professor at the London School of Hygiene and Tropical Medicine.

Saad  Shakir, MD, FFPM, FISPE, FRCP

Saad Shakir, MD, FFPM, FISPE, FRCP

Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, 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. 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. Saad will start a new stage in his career as a consultant in Pharmacovigilance and Pharmacoepidemiology on 1 June 2025

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.

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