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Bethesda North Marriott Hotel and Conference Center

2023 年 02 月 05 日 9:00 上午 - 2023 年 02 月 05 日 5:00 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Short Course: Pharmacovigilance and Risk Management Planning

This is a In-Person Pre-Conference Short Course in conjunction with the Global Pharmacovigilance and Risk Management Strategies Conference

Instructors

Stella  Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

Strategy , Consultant, United Kingdom

Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTM, Stella studied medicine at Cambridge and Guys, working in hospital medicine before joining the pharma industry. She has worked in PhV and pharmacoepi for 35 years: in industry (11+ years) as a regulator (16+ years) and CRO (9 years). Following her MSc in Epidemiology from LSHTM, she co-developed their course in PhV and Pharmacoepi. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU strategy and policy on risk management, was lead writer on the EU guidelines on this and was part of the core team implementing the 2010 PhV legislation and ENCePP. She is/was on the CIOMS IX/XI/XIII working parties and is a member of the CIOMS Executive Committee.

Sarah  Frise, PhD, MS

Sarah Frise, PhD, MS

Global Head Safety Epidemiology and Risk Management, AstraZeneca, Canada

Sarah holds a Masters Degree in Physiology and Phd in Epidemiology. Sarah holds the position of the Global Head Safety Epidemiology and Risk Management at AstraZeneca. She is an active member of many Pharmacovigilance and Safety epidemiology working groups including Beyond Covid Monitoring (BeCOME), ISPE BRACE, IMI Gravitate. In addition to pharmacoepidemiologic methods related to the conduct of Safety Epidemiology studies, she has a special interest in designing and implementing Risk Minimisation/Mitigation Interventions and assessing the effectiveness of these interventions.

Alie  Banner Simpson

Alie Banner Simpson

Scientific Assessor, Benefit and Risk Management Group, Unit 1, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

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