#43: The Good Pharmacovigilance Practices in the EU: Global Applications
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
- 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
- Drug Safety Research Unit, United Kingdom
Saad Shakir is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications on pharmacovigilance and pharmacoepidemiology.