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Russia and the Eurasian Union – Regulatory Challenges and Opportunities

Track:
Hot Topic/Stand Alone

Day & Time:
April 18, 4:00PM - 5:30PM (Central Europe Standard Time)

Session Number:
S1003

Room Number:
Shanghai 1-2

Type:
Session

Title:
Russia and the Eurasian Union – Regulatory Challenges and Opportunities

Chair(s):
Susanne Ausborn, PhD
Lead Regulatory Policy EEMEA
Hoffmann-La Roche Ltd, Switzerland

Description:
The regulatory landscape in Russia and the “single market” of the Eurasian Union are rapidly evolving. Experts will share their perspectives on recent developments in the region and discuss the challenges we are facing with sometime very unique regulatory requirements. Examples for constructive dialogue between industry and regulators will be shared which is critical to bring and safe and efficacious drugs of high quality as fast as possible to the patients and maintain them on the market.

Presentation(s) & Speaker(s):
Regulatory Harmonisation within the Eurasian Union – Where Do We Stand?
Dzmitry Razhdzestvenski, MD, PhD
Head, Division for Coordination of Common Market for Drugs and Medical Devices F
Eurasian Economic Commission, Russian Federation

Regulatory Harmonisation within the Eurasian Union – Where Do We Stand?
Sergey Glagolev
Deputy Chief, Division for State Control of Medical Products
Federal Service for Supervision in Health Care (Rosdravnadzor), Russian Federation

Establishing EEU Guidance - Driving Towards Regulatory Convergence - Industry Perspective
Elena Popova
Senior Director Regulatory Affairs & Healthcare Policy
Association of International Pharmaceutical Manufacturers (AIPM), Russian Federation

Recent Developments and Challenges in Russia - Industry Perspective
Andrey Bulimov
Head of RA Partner Business CEE & LATAM
Vifor Pharma , Switzerland