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The Eurasian Union - Reflection on the Changes in Regulatory and Ways of Working
Session Chair(s)
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
The first EEU regional submissions procedures have been kicked off and regulators as well as companies are gaining their first experiences. Where do we stand and what needs to be addressed to ensure smooth implementation of procedures and guidelines? We will outline the EEU regulatory framework and recent changes / challenges within EEU and Russia regulations Illustrate experience gained during first submissions/approvals by sharing regulators and industry perspective Identify what to do better and how
Speaker(s)
Implementing the Eurasian Regulatory System - Where Do We Stand and How Do We Prepare for the New Developments Addressing Unmet Medical Need
Rustam Abdussalamov, MPA
National Center For Expertise of Medicines, Medical Devices and Medical Equipmen, Kazakhstan
Chief Development Officer
Implementing the Eurasian Regulatory System - Where Do We Stand and How Do We Prepare for the New Developments Addressing Unmet Medical Need
Dmitriy Goryachev, DrMed, PhD
Center of Expertise and Quality Control of Medicinal Products, Moh Russian Feder, Russian Federation
Director
Panel Discussion
Elena Popova, DrMed
Association of International Pharmaceutical Manufacturers (AIPM), Russian Federation
Senior Director Regulatory Affairs & Healthcare Policy
Panel Discussion
Florent Hartmann, PharmD, MS
Novartis Pharma AG, Switzerland
Regulatory Sub-Region Head
Panel Discussion
Tomas Salmonson, DrMed, PhD
Critical Path Institute, United States
Partner
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