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Medical Device and IVD Regulations in Russia, CIS, CEE and Turkey

Update on regulation for medical devices and IVD in Russia, CIS, CEE and Turkey

Don't miss this opportunity to get critical updates from top regulator and industry speakers on regulation in Russia including an update on the new updoming medical device regulations in Russia, Also a crucial regulatory update from CEE countries (including the Balkan States, Croatia, Serbia and Bosnia). Also a fantastic opportunity to gain practical advice on registration in Russia, CIS countries and CEE countries.

Hear an essential update on harmonisation including the Customs Union of Russia, Belarus and Kazakhstan.

Also gain practical advice on effective strategy for dealing with distributors and local representatives in Russia and CIS countries and assessing language challenges for submissions and labelling within CEE countries.

2012 Conference Highlights: Latest updates on regulation and market access in Russia, CIS, CEE and Turkey

Critical update on the new medical device regulations in Russia as well as a comprehensive overview of Russia's current regulatory system

Essential regulatory update from key CEE countries (including the Balkan States, Croatia, Serbia and Bosnia) - hear from the Croatian Agency for Medicinal Products and Medical Devices and also the Medicines and Medical Devices Agency of Serbia

Exploring harmonisation in Russia and CIS countries, including an update on the Customs Union of Russia, Belarus and Kazakhstan

Essential insight and real life case studies on registration in Russia  and practical advice for medical device approval in Russia including practical advice on how to deal with the new medical device regulations

Essential insight into the Country of Origin requirements in Russia and other CIS countries

Practical advice on dealing with distributors and local representatives in Russia and other CIS countries

Exploring language challenges for submissions and labelling in CEE countries

Expert Speaker Panel

Sinisa Tomic, European Affairs Counsellor, Croatian Agency for Medicinal Products and Medical Devices, Croatia

Branislav Radivojevic, Professional Assessor, Medical Devices Department, Medicines and Medical Devices Agency of Serbia, Serbia

Alexander Schapovalov, MHS – Foreign Affairs, TÜV SÜD Product Service GmbH, Germany

Dmitry Zubarev, General Director, The Center of Certification and Declaring, LLC, Russia

Enrico Schuur, Director Regulatory Affairs International, Medtronic International Trading Sarl, Switzerland

Kristina Mumber, Head of Regulatory Affairs EMEA, Novartis Vaccines and Diagnostics, Switzerland

Anna Firstova, Regulatory & Quality Manager, Zimmer CIS, Russia

Claudia Pres, Regulatory Affairs Manager EMA, Becton Dickinson, Germany (tbc)

Pavel Henčl, General Manager CIS Region, Gambro, Germany

Maria Obreztchikova, Sr. Regulatory Affairs Specialist, St. Jude Medical, USA

Alexander Berezin, Country Manager Russia and CIS, Edwards Lifesciences, Russia

Olga Orekhova, Regulatory Affairs Director Russia and CIS, GE Healthcare, Russia

Ondina Grigorescu, Regulatory Affairs and Quality Assurance Manager EEMEA, C. R. Bard GmbH, Germany

Tom Ståhlberg, Director, Government Affairs, Regulatory and Clinical Affairs, PerkinElmer, Finland

Andrey Ivanov, Group STM LLC, Russia

Keith Summerhayes, Managing Director & Clinical Affairs Consultant, MDCRQ Solutions Ltd., UK

 



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Workshops and Evening Seminar

PRE-CONFERENCE SYMPOSIUM

Monday 8 October 2012

Success in the Turkish market: Regulatory update and effective market access

Olgun Sener, Education Expert/Public Administration Expert, Ministry of Health, Turkey

Gozdem Delipinar, Quality Assurance and Regulatory Affairs Manager, Alvimedica. Turkey

POST-CONFERENCE SYMPOSIUM

Thursday 11 October 2012

Success in the Middle East: Regulatory Updates and Effective Market Access

Norbert Stuiber, Operations Manager MHS, TUV SUD Middle East, Saudi Arabia

Claudia Ising, Head of Regulatory Affairs, Lohmann & Rauscher, Germany

EVENING SEMINAR
Tuesday 9 October 2012

Essential clinical considerations in Russia and other CIS countries

Keith Summerhayes, Managing Director & Clinical Affairs Consultant, MDCRQ Solutions Ltd., UK

Victoria Cavendish, Senior Clinical Projects Manager, Reckitt Benckiser Healthcare, UK

Who Should Attend?

Directors/Senior Managers/Managers/Head of/Team Leader/Specialist/Officer:

  • Regulatory Affairs
  • Vigilance
  • Compliance
  • Quality Assurance
  • Quality Control
  • Clinical Affairs

 

 

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Dates and Venues

09 Oct 2012 - 10 Oct 2012

Continental Zara Hotel, Budapest, Hungary

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