Pharmacoepidemiological safety studies using real world observational data are essential to drug development. This presentation will begin by defining the ways in which pharmacoeidemiology can support a broader risk assessment and pharmacovigilance environment in a pharmaceutical industry setting. It will discuss the specific reasons why observational data are critical, in addition to clinical trial data, for the assessment of drug safety, for example for continued assessment of drug safety beyond the launch of a product, study of patients not included in the clinical trial populations, and the study of relatively rare or long-time-to-onset safety outcomes. Finally, a real-life case study will be presented which will provide an example of a non-interventional post-authorisation drug utilisation and safety study (PASS) for a new second generation antipsychotic, and will discuss where the results of this will lead us.
Shreya Davé is Director of Pharmacoepidemiology (Global Pharmacovigilance) at Takeda Development Centre Europe, where she provides epidemiological and risk management support for drug safety. Prior to this, she was Senior Research Associate at United BioSource Corporation, and held several academic research posts including at University College London, The UK Medical Reasearch Council and The University of Hertfordshire. She has worked in various therapeutic areas, but has a particular interest in mental health, and has extensive experience of research using large observational healthcare databases. Shreya has a PhD in Primary Care and Population Health from University College London (UCL), an MSc in Medical Demography from the London School of Hygiene and Tropical Medicine, and a BSc (Hons) in Biochemistry from King’s College London.