戻る Agenda
The Eurasian Union Regulatory Framework - Now a Reality
Session Chair(s)
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Elena Popova, DrMed
Senior Director Regulatory Affairs & Healthcare Policy
Association of International Pharmaceutical Manufacturers (AIPM), Russian Federation
EAEU regional submissions procedures for alignment and new products have been kicked off in 2019 and regulators as well as companies have gained their first experiences. Where do we stand & what needs to be addressed to ensure smooth implementation?
Learning Objective : Familiarize with Medicines regulation in the EAEU and the implications Understand the challenges from regulators and industry perspective related to filings under the EAEU regulatory framework reflect on
Speaker(s)
Panelist
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Panelist
Dmitriy Rozdestvensky, MD, PhD
Eurasian Economic Commission, Russian Federation
Head, Division for Coordination of Common Market for Drugs and Medical Devices F
Panelist
Dmitriy Goryachev, DrMed, PhD
Center of Expertise and Quality Control of Medicinal Products, Moh Russian Feder, Russian Federation
Director
Panelist
Anna Igorevna Lakhtanova
LLC Novartis Pharma, Russian Federation
Head of Regulatory Department
Panelist
Vera Rozhnova
F.hoffmann-La Roche Ltd., Switzerland
Technical regulatory manager
Panelist
Representative Invited
Ministry of Health