Two Day Seminar: Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union (London, United Kingdom - March 1st-2nd, 2018)

This interactive meeting will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation, which came into force in 2016.

The aim of this meeting is to provide an overview of recent regulatory developments in pharmaceutical regulatory affairs in Russia and the Eurasian Union. This interactive meeting will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation, which came into force in 2016. The focus will be on practical aspects to assist in developing your regulatory strategy for product approval in these countries and the presentations will also give practical hints on the regulatory process where possible.

Who should attend?

This seminar will be of particular interest to:

After attending this programme you will:

Attending this programme will:

Agenda:

Introduction and welcome

Russia - competitive landscape

Clinical trials in Russia and CIS

Marketing authorisations in Russia

CIS - regional regulatory overview

Marketing authorisations in CIS

- administrative data
- translations
- CPP
- Dossier format
- local normative documents
- samples
- labelling

Country specific requirements for MAAs:
- Ukraine, Kazakhstan, Belarus, Moldova, Georgia, Armenia, Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan, Kirgizstan
Regional regulatory strategy

Workshop - CIS Regional Regulatory Strategy

Discussion will take place throughout the two days

For more information about this conference visit https://www.researchandmarkets.com/research/634lv2/two_day_seminar?w=5

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Research and Markets
Laura Wood, Senior Manager
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