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REGULATORY HARMONISATION AND REGULATORY CONVERGANCE - AN UPDATE

Track:
Globalisation/Inspections

Day & Time:
March 26, 9:00AM - 10:30AM (Central European Standard Time)

Session Number:
1001

Room Number:
Room LM

Type:
Session

Title:
REGULATORY HARMONISATION AND REGULATORY CONVERGANCE - AN UPDATE

Chair(s):
Lembit Rago, MD, PhD
Head, Regulation of Medicines and other Health Technologies
World Health Organization (WHO), Switzerland

Description:
Regulatory harmonisation and convergence initiatives continue to be very active throughout the globe. In this session, we have brought together speakers who are able to provide experience from different regions and perspectives.

Presentation(s) & Speaker(s):
Current status and challenges of bilateral/multilateral meetings
Junko Sato, DrSc, PhD
Director, Division of Regulatory Cooperation, Office of International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Experience of Accession
Viola Macolic Sarinic, DrSc, MD, MSc
Head of Agency
Agency For Medicinal Products & Med. Devices (HALMED), Croatia (Hrvatska)

Regulatory Harmonisation and Convergence – An Update from Low- and Middle-Income Countries
Murray M. Lumpkin, MD, MSc
Deputy Director, Regulatory Affairs, Global Health and Integrated Development
Bill and Melinda Gates Foundation, United States