Course 2: Pharmacovigilance and Risk Management Planning
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
- Vice President, Global Head of Early Access and Risk Management
- IQVIA, United Kingdom
Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTP, Dip Pharm Med.VP, Global Head of Early Access & Risk Management, Real World Insights at IQVIA. Stella studied medicine at Cambridge and Guys and worked in hospital medicine before joining the pharmaceutical industry. She has worked in pharmacovigilance and pharmacoepidemiology for 30 years: in industry (11+ years) as a regulator (nearly 17 years) and CRO (3+ years).She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU policy on risk management, writing the EU guidelines on this topic and was part of the core team implementing the 2010 PhV legislation.
William Gregory, PhD
- Safety and Risk Management
- Pfizer Inc, United States
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.