International Harmonization & Regulator Forum

Thursday, September 19, 2024

4:30 PM – 5:30 PM PDT

Location/Room: 104 C

Moderator(s)

Olga Van Grol-Lawlor, MPHIL

Sr. Global Regulatory Intelligence & Advocacy Manager
Boston Scientific, Netherlands

Slides

Presenter(s)

Jasjit Baveja, PhD

Associate Director, Policy
Medical Technology Association of Australia, Australia
Tshetsana Senau

Research Officer- Clinical Trials and Research
Botswana Medicines Regulatory Authority, Botswana

Presenter (Remote)(s)

PW

Paulyne Wairimu

Chair of the African Medical Devices Forum
Pharmacy and Poisons Board, Kenya

Panelist (Remote)(s)

Faiza Alzadjali

Presenter(s)

Stephen Lee

Director of Diagnostics & Digital Regulation
ABHI, United Kingdom

In this session you will have the opportunity to hear updates on the latest developments from three different continents, a rare insight into Europe, Australia and Africa. We will delve into the progress made by programs such as the International Medical Device Regulators Forum (IMDRF) in advancing international regulatory harmonization and convergence for medical devices. With increasing international interest in reliance practices, the session will explore the opportunities and challenges presented by greater regulatory reliance. Panelists will share concrete examples of the benefits of regulatory reliance, discuss the benefits and further potential of programs such as the Medical Device Single Audit Program (MDSAP), and examine the evolving role of global regulatory convergence & harmonization in their regions. Come hungry for information and come prepared with your own questions!

Learning Objectives:

Describe the progress made by programs such as IMDRF in advancing international regulatory harmonization and reliance
Understand the challenges and opportunities presented by greater regulatory reliance
Discuss concreate examples of regulatory reliance (e.g. MDSAP) and the evolving role of regulatory convergence and harmonization in various global regions