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New Approaches to International Collaboration Between Regulators (Part 1 of 2)

Track:
Global Regulatory

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
121

Room Number:
6F

Level:
Intermediate

Type:
Forum

Title:
New Approaches to International Collaboration Between Regulators (Part 1 of 2)

Chair(s):
Emer Cooke, MBA
Head of International Affairs
European Medicines Agency, European Union, United Kingdom

Description:
Starting with the original ICH partners, this forum will explore how the model of regulatory collaboration is evolving from traditional harmonization and information sharing models to strategic coalitions and work-sharing initiatives. It will examine emerging efforts to avoid duplication and increase mutual reliance between regulators and their impact on industry.

Part 2 will take place on Monday at 11:00 AM (Session #144).

Learning Objective(s):
Discuss the current challenges facing international regulators including how this impacts the pharmaceutical industry and patients; Describe emerging international regulatory initiatives.

Presentation(s) & Speaker(s):
Panelist
Sandra L. Kweder, MD, FACP
Deputy Director, Office of New Drugs, CDER
FDA, United States

Panelist
Guido Rasi, MD
Executive Director
European Medicines Agency, European Union, United Kingdom

Panelist
Tatsuya Kondo, MD, PhD
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Panelist
Supriya Sharma, MD, MPH, FRCPC
Associate Assistant Deputy Minister of Health Products and Food Branch
Health Canada, Canada