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Tuesday, June 18 • 1:15pm - 2:15pm
#244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-582-L04-P; CME 1.00; RN 1.00

This session will discuss the recent shifts in evidence-based regulatory decision-making, to include types of evidence used to support decisions. Future requirements for evidence generation to support regulatory decision-making will be considered.

Learning Objectives

Describe the need for evidence generation to support regulatory decision-making; Discuss the changing evidence landscape supporting regulatory decision-making; Identify what is needed in the future.

Chair

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Speaker

Industry Update
Andrew Bate, PhD, MA

Industry Update
Jeremy Jokinen, PhD, MS

Trends in Evidence Use During Pharmacovigilance Evaluations
Samantha Lane, MSc


Speakers
avatar for Saad Shakir

Saad Shakir

Director, Drug Safety Research Unit, United Kingdom
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... Read More →
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Samantha Lane

Samantha Lane

Head of Research, Centre of Pharmacovigilance Sciences, Drug Safety Research Unit, United Kingdom
Samantha Lane is a Senior Research Fellow and the Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit. Samantha leads study design and statistical analysis and has experience with the CPRD electronic health records database. She has a background... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session