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Austria Center Vienna

2019年2月05日 (火) 午前 7:00 - 2019年2月07日 (木) 午後 5:00

Bruno-Kreisky-Platz 1, 1220 Vienna, Austria

DIA EUROPE 2019

The Eurasian Union - Reflection on the Changes in Regulatory and Ways of Working

Session Chair(s)

Susanne  Ausborn, PHD

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)

Rustam  Abdussalamov, MPA

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

Dmitriy  Goryachev, DrMed, PHD

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

Elena  Popova, DrMed

Panel Discussion

Elena Popova, DrMed

Association of International Pharmaceutical Manufacturers (AIPM), Russian Federation

Senior Director Regulatory Affairs & Healthcare Policy

Florent  Hartmann, PHARMD, MS

Panel Discussion

Florent Hartmann, PHARMD, MS

Novartis Pharma AG, Switzerland

Regulatory Sub-Region Head

Tomas  Salmonson, DrMed, PHD

Panel Discussion

Tomas Salmonson, DrMed, PHD

Critical Path Institute, Netherlands

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