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McCormick Place

2017 年 06 月 18 日 9:00 上午 - 2017 年 06 月 18 日 5:00 下午

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

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

Instructors

Kristina  Strutt, MD, MA, MRCP, FFPM

Kristina Strutt, MD, MA, MRCP, FFPM

Senior Vice President, Ipsen Biopharm Limited, United Kingdom

Kristina studied medicine at Cambridge and London Universities in the UK. She has 28 years Clinical Development and Drug Safety pharma experience in the UK, Switzerland and Germany. She lectures in pharmacovigilance on various courses in the UK, and is an examiner for the Faculty of Pharmaceutical Medicine. She is a Member of The Royal College of Physicians UK, a Fellow of The Faculty of Pharmaceutical Medicine, and holds specialist registration in pharmaceutical medicine with the GMC in the UK.

Shelley  Gandhi, MSc

Shelley Gandhi, MSc

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group, United Kingdom

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented the UK on EMAs EudraVigilance Expert Working Group. Shelley now supports clients with QPPV, Risk Management, Inspection Readiness and implementation of global PV systems.

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.

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