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