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Data and Evaluation Needed for Robust Evidence: Regulators' Challenges
Session Chair(s)
Yoshihiko Ono, RPh
Head of Regulatory Affairs
MSD K.K., Japan
In recent years, the use of information based on the analysis of various data sources has been proactively promoted in decision-making processes of regulatory agencies. In this session, we will discuss the recent achievements and future challenges of regulatory agencies, focusing on how to make robust evidence with the efficient utilization of various data. We will also discuss the impact through the life cycle of medicinal products and common regulatory challenges.
Learning Objective : Discuss regulatory frameworks utilizing various data sources to make robust evidence on benefit-risk of medicinal products.
Speaker(s)
PMDA Perspective: Challenges For Postmarketing Drug Safety Measures Using Electronic Health Care Database
Kaori Yamada, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Pharmacovigilance 1
EMA Perspective
Kevin Blake, MD, PhD
European Medicines Agency, Netherlands
Clinical Epidemiologist
FDA Perspective
Robert Ball, MD, MPH, MSc
FDA, United States
Deputy Director, Office of Surveillance and Epidemiology, CDER
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