Plenary: Pragmatic Pharmacoepidemiology: Innovative Clinical Evidence Supporting Regulatory Decision-making

Sunday, August 24, 2025

8:00 AM - 10:00 AM ET

Location: Ballroom AB

Presenting Author(s)

DR

Donna Rivera

Food and Drug Administration, United States
Meredith Y. Smith, PhD, MPA, FISPE

Senior Director
Evidera. Inc., PPD, a part of Thermo Fisher Scientific
Boston, Maryland, United States
PV

Patrice Verpillat, MD, MPH, PhD

Head of Real World Evidence
European Medicines Agency, Netherlands
DC

David Chambers
JB

Jeffrey S. Brown, PhD

Chief Scientific Officer
TriNetX
Needham, Massachusetts, United States
EG

Elizabeth Garrett-Mayer, PhD

Division Director
American Society of Clinical Oncology, United States

This plenary session will focus on innovative pragmatic designs that span the continuum from interventional to non-interventional studies. Pharmacoepidemiologists have an emerging role to play in the design and evaluation of the methodological elements of these pragmatic studies. Attendees will gain insights into the scientific, clinical, operational, and regulatory considerations involved in designing such studies, which seek to improve patient experience and access, increase representativeness, and generate evidence that more accurately reflects real-world health outcomes.