Understanding and Interpreting Studies Using Real-World Data

Prof Saad Shakir MB ChB, LRCP&S FRCP FISPE MRCGP
Director,Drug Safety Research Unit

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 in Southampton.

The DSRU is an academic unit associated with 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.  Saad serves as a Chairman or member of Safety Advisory Boards and Data Safety Management Committees. He is an author of many book chapters and publications in scientific journals on pharmacovigilance, pharmacoepidemiology and risk management and is a member of the editorial boards for the journals Drug Safety and Pharmacoepidemiology and Drug Safety.

Saad Shakir has led and co-ordinated many post graduate educational and training programmes including the MSc programme in Pharmacovigilance at the DSRU. He supervises post graduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London; a Fellow of the Faculty of Pharmaceutical Medicine; a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the UK.

Email: saad.shakir@dsru.org

Debabrata Roy
Head of Epidemiology, Drug Safety Research Unit

Debabrata is a Pharmacoepidemiologist and the Head of Epidemiology and Research at the DSRU, joining in 2015. He is also an Honorary Associate Professor in the School of Pharmacy and Biomedical Sciences at the University of Portsmouth. He has a pre-clinical research background and holds a BSc in Pharmacology (University College London), an MSc in Drug Discovery Skills (King’s College London) and completed his PhD in Neuroendocrinology from Imperial College London. He has trained in Epidemiology, gaining an MSc from Imperial College London and in Pharmacovigilance (PgD) from the University of Portsmouth.

Debabrata has oversight of and leads a team conducting Real-World Evidence (RWE) drug safety studies utilising Real-World Data. This includes study design, methodology and the statistical analysis of Post-Authorisation Safety Studies (PASS) involving Modified-Prescription Event Monitoring (M-PEM), Specialist Cohort Event Monitoring (SCEM), Active Surveillance, Registries and Clinical Practice Research Datalink (CPRD) database studies, as well as systematic Benefit-Risk assessments and systematic reviews.

Debabrata is also a Vaccine monitoring Collaboration for Europe (VAC4EU) Executive Board member, Associate Editor with Therapeutic Advances in Drug Safety and a CPRD Expert Review Committee member.

Samantha Lane
Senior Research Fellow (Research and Innovation) / Head of Research at the DSRU Institute for Pharmacovigilance and Pharmacoepidemiology Sciences, Drug Safety Research Unit, UK

Samantha is a Senior Research Fellow and Epidemiologist at the DSRU, having joined in 2017. She has a background in biomedical science and holds an MSc in Medical Microbiology (University of the West of England) and an MSc in Epidemiology (London School of Hygiene and Tropical Medicine). She has also completed the PgD in Pharmacovigilance from the University of Portsmouth.

Samantha is heavily involved in both methodological research and pharmacoepidemiological studies. She has experience with study design and data analysis, including the analysis of electronic health records data from the CPRD database, and has also been involved with conducting systematic benefit/risk assessments.