Skip to main content
ASCPT 2024 Annual Meeting Main banner
Back

Global Health (GH)

Regulatory Science (RS)

Expanding Regulatory Science: Regulatory Complementarity and Reliance

Friday, March 29, 2024
11:00 AM – 12:00 PM MDT

Session Description

This session will advance the notion that significant, untapped, asymmetric potential exists for novel regulatory insights to flow from regulators in low- and middle-income countries to regulators in high-income countries. Recognition and attention to these differences would strengthen the bidirectional flows between regulators across countries.

Learning Objectives

1. Upon completion, participants will be able to define the regulatory reliance policy that enables an authority in one country to leverage the regulatory work performed by a competent and trusted regulatory authority or institution in another country
2. Upon completion, participants will be able to define the advantages of recognizing and addressing differences in intrinsic and extrinsic factors across global contexts.
3. Upon completion, participants will be able to define the steps required to enhance the regulatory reliance policy and move toward regulatory complementarity.

Session Schedule

11:00 AM - 11:10 AM MT
Introduction to Regulatory Complementarity
Dan Hartman, MD

11:10 AM - 11:20 AM MT
FDA Perspectives on International Collaborations
Shirley Seo, PhD

11:20 AM - 11:30 AM MT
Reliance and Complementarity – Perspective from Uganda NDA
Helen B. Ndagije, PhD

11:30 AM - 11:40 AM MT
A Journey from Safety Signals to Risk Factors to Product Labeling
Jackson Mukonzo, PhD,

11:40 AM - 12:00 PM MT
Panel Discussion and Q&A
Moderators: David Wesche, MD, PHD and Ted Grasela, PharmD, PhD