spacer
home > pmps > autumn 2003 > handling clinical trial materials in russia
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

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


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.





spacer
Sergei Varshavsky
spacer
spacer
spacer
Anna Ravdel
spacer
spacer
spacer
Pyotr Platonov
spacer
spacer
spacer
Svetlana Timofeeva
spacer
spacer
spacer
Nadia Nurutdinov
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

CPhI expert forecasts ‘huge growth in Middle East manufacturing with Europe a medium-term target’

CPhI Middle East & Africa (CPhI MEA) expert Madhukar Tanna, Chief Executive Officer of Pharmax, a United Arab Emirates (UAE) based branded generic manufacturer, says favourable conditions in the UAE are resulting in a boom of pharmaceutical manufacturing throughout the region. Government incentive schemes to increase domestic production, coupled with a brand friendly environment and rising healthcare needs is fuelling surging demand – with many new companies and plants launching in the last two years alone.
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement