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Handling Clinical Trial Materials in Russia

The years when Russia was a 'blind-spot' on the clinical trials world map are now far away. Before Perestroika, there was neither good clinical practice nor regulations of clinical trials in Russia and Eastern Europe; one could not find copiers because it was illegal; long-distance phone calls were made through switchboard operators, there were no fax machines, nor were there computers or the Internet - people knew hardly anything about clinical studies.

The situation has been dramatically changing over the past 15 years. Some Eastern European countries are becoming European Union members and ICH GCP rules are now part of their legislation. Russian regulations now include:

A Russian-language version of ICH GCP which has become an industry standard since 1999 (1)
Rules of Clinical Practice which went into operation 19th June 2003 (2)
The Federal Drug Law of 1998 (3) establishing an authorities system which manages all the governmental activity in respect to drugs circulation


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By Sergei Varshavsky, MD, PhD, Chairman and CEO, Anna Ravdel, MBA, Director of Marketing and Business Development, Pyotr Platonov, MD, PhD, Scientific Director, Svetlana Timofeeva, MD, PhD, is Head of the Moscow Representative Office, and Nadia Nurutdinov, Account Manager, at Evidence Clinical and Pharmaceutical Research

Sergei Varshavsky MD, PhD is Chairman and CEO of Evidence Clinical and Pharmaceutical Research, a global CRO, conducting multinational clinical trials in Russia and Eastern Europe. Sergei received his medical training at the First Medical School and Postgraduate Medical School, St Petersburg in Russia and began his career as a Researcher at Research Institute of Cardiology in St Petersburg. Over the past 13 years, Sergei has been directly involved in all clinical trials conducted by Evidence. He has been a National Co-ordinator for large multicentre studies. Sergei shares his expertise in more than 40 publications in international scientific journals. He was the first clinician to conduct a quality of life study in Russia


Anna Ravdel, MBA is Director of Marketing and Business Development at Evidence Clinical and Pharmaceutical Research. Anna received her MBA degree in Israeli affiliate of Manchester University in 2001. She joined Evidence CPR in Russia in 2002 and became familiar with local regulations and drug legislation before moving to the US, where she is directly involved in global business development and marketing projects.


Pyotr Platonov MD, PhD is the Scientific Director at Evidence Clinical and Pharmaceutical Research. A Cardiologist by training, Pyotr graduated from Pavlov's Medical University in St Petersburg (Russia) in 1994 and worked at St Petersburg Research Institute of Cardiology for several years combining clinical medicine with research. He earned his PhD in the field of Cardiac Electrophysiology at Lund University, Sweden in 2001. He joined the Evidence team in 1997. Since then he has been involved in the management of clinical operations and GCP consulting and training, before becoming Scientific Director.


Svetlana Timofeeva, MD, PhD is Head of the Moscow representative office at Evidence Clinical and Pharmaceutical Research. Dr. Timofeeva joined Evidence CPR in 1998 as Head of Moscow representative office. Since then she has been directly involved in all Evidence clinical trial activities, including regulatory submissions and customs clearance in multiple international clinical trials. She gained medical experience as a Cardiologist at Institute of Preventive Cardiology and as an Echocardiography Specialist at State Research Center for Preventive Medicine in Moscow.


Nadia Nurutdinov is an Account Manager at Evidence Clinical and Pharmaceutical Research. Nadia joined the Evidence team in California in February 2001. In her current position she is involved in all financial and accounting issues, including financial relationships with regulatory authorities in Russia.





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Sergei Varshavsky
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Anna Ravdel
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Pyotr Platonov
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Svetlana Timofeeva
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Nadia Nurutdinov
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