Medicines and Healthcare products Regulatory Agency
Puja Myles

Director, Clinical Practice Research Datalink at Medicines and Healthcare products Regulatory Agency

  Canary Wharf, London E14 4PU, United Kingdom

About me

Puja Myles is Director of the Medicines and Healthcare products Regulatory Agency’s (MHRA) specialist real world data research service, the Clinical Practice Research Datalink (CPRD). She is a public health specialist and epidemiologist. Prior to joining CPRD, was a public health academic at the University of Nottingham, UK. She is a fellow of the Faculty of Public Health (UK), a senior fellow of the Higher Education Academy (UK) and has a doctorate in epidemiology. Her current research covers real world data, data quality and AI regulatory policy including topics like AI explainability, synthetic data, in silico trials and concept drift in AI.

Schedule

My Session

Pharmacoepidemiology and Real-World Evidence (RWE) Generation
  • The role of real-world evidence in the evaluation of drug safety and effectiveness in diverse patient populations
  • The practical applications of real-world evidence in informing regulatory decisions, clinical guidelines, and healthcare policies
  • The challenges in utilizing real-world evidence, such as data quality, bias, and standardization
  • Emerging trends and innovations in pharmacoepidemiology and RWE generation for evidence-based healthcare with a focus on target trial emulation

Puja Myles

Director, Clinical Practice Research Datalink at Medicines and Healthcare products Regulatory Agency


Data management & Analytics
Post-Marketing Surveillance
Patient Safety
Panel Discussion - Leading Pharmacovigilance in a Changing Landscape: What Needs to Evolve Next?

A discussion on how leadership in pharmacovigilance is evolving in response to increasing data, regulatory expectations, and technological change.

  • What are the biggest shifts you’re seeing in pharmacovigilance today?
  • How is the role of PV leaders changing within organisations?
  • What capabilities will future PV teams need to succeed?
  • Where should organisations focus to stay ahead in this evolving landscape?

Quality Assurance
Patient Safety
Global Pharmacovigilance
Adverse Drug Reactions

Michael Ramcharan

Managing Director at Reumat Consulting

Puja Myles

Director, Clinical Practice Research Datalink at Medicines and Healthcare products Regulatory Agency

Joanne Rogerson

Director of Operations at Resolver

Sandra Reda

Senior Pharmacovigilance Specialist at Newbridge Pharmaceuticals

Jean-Marc C. Haeusler

Global Head International Patient Safety at Roche

Aliki Taylor

Executive Director, RWE TA Head - Oncology at Gilead Sciences