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Thursday, February 7 • 10:45 - 11:45
#S0806: The Eurasian Union - Reflection on the Changes in Regulatory and Ways of Working

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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

Chair

Susanne Ausborn, PhD

Speaker

Implementing the Eurasian Regulatory System - Where Do We Stand and How Do We Prepare for the New Developments Addressing Unmet Medical Need
Rustam Abdussalamov, SR, MPA

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

Panel Discussion
Elena Popova, DrMed

Panel Discussion
Florent Hartmann, PharmD, MS

Panel Discussion
Tomas Salmonson, PhD


Speakers
avatar for Rustam Abdussalamov

Rustam Abdussalamov

Chief Development Officer, National Center For Expertise of Medicines, Medical Devices and Medical Equipmen
avatar for Susanne Ausborn

Susanne Ausborn

Regulatory Policy Lead, Hoffmann-La Roche Ltd
M.Sci. in Analytical Chemistry, PhD in Biophysical Chemistry with Roche since 2001 currently Head Regulatory Policy & International Operation EEMEA, extensive experience with global filings, strong advocate for global regulatory convergence, engaged in numerous workshops/ meetings... Read More →
avatar for Dmitriy Goryachev

Dmitriy Goryachev

Director, Center of Expertise and Quality Control of Medicinal Products, Moh Russian Feder
I graduated from the Moscow Sechenov Medical Academy in 1995. I worked as a research doctor at the Institute of Rheumatology of the Russian Academy of Medical Sciences. Since 2003 - employee of the Center of expertise. The main area of work was related to the evaluation of painkillers... Read More →
avatar for Florent Hartmann

Florent Hartmann

Regulatory Sub-Region Head, Novartis Pharma AG
Florent Hartmann is currently Regulatory Sub-Region Head at Novartis, responsible for regulatory oversight of Region Europe countries including Eurasian Economic Union. He is a pharmacist with over 12 years of experience in global Regulatory Affairs, including drug development, clinical... Read More →
avatar for Elena Popova

Elena Popova

Senior Director Regulatory Affairs & Healthcare Policy, Association of International Pharmaceutical Manufacturers (AIPM)
Elena has broad experience in R&D, RA, business development, and healthcare policy. She graduated from Russian State Medical University, holds PhD degree in medicine, and eMBA degree in Strategic Management from University of Antwerp, Belgium. Elena in her role in AIPM is responsible... Read More →
avatar for Tomas Salmonson

Tomas Salmonson

Senior Scientific Advisor, Medical Products Agency (MPA)
Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency... Read More →

Thursday February 7, 2019 10:45 - 11:45
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  08 Regional Updates, Session
  • Featured Topics Regulatory Science
  • Tags Session