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WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets

Part 2
Conducting Clinical Trials in Russia and Kazakhstan

October 12, 2012

Speakers for this Event:
  • Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department
        (ROSZDRAVNADZOR)   Learn More
  • Igor Stefanov, Director, General Manager, Synergy Research Group   Learn More
  • Anna Ravdel, Director of Business Development, Synergy Research Group   Learn More

  • This second webinar in our series will examine the the advantages and disadvantages of conducting clinical trials in Russia and Kazakhstan.

    This region offers the benefits most pharmaceutical and biotechnology companies most commonly search for when outsourcing their clinical trials process: high quality, high speed, and low costs.

    Why Russia and Kazakhstan? We will discuss why the "Russian Troika" makes these 2 countries an ideal choice for location.  “Troika” meaning “three horse team” in Russian refers to

    • Horse # 1 – Quality
    • Horse #2 – Speed
    • Horse # 3 – Costs

    We will discuss how Russia and Kazakhstan meet the challenge by combining these three basic qualities in clinical trials

    Clinical Trials in Russia (including an update for 2012): Igor Stefanov will analyse the current state of the clinical trial market in Russia, upcoming trends and a comparison with historical data. His report will follow SynRG's Orange Paper plus coverage of new developments in the first nine months of 2012. Mr. Stefanov's presentation will include valuable figures, tables and pictures covering various aspects of the Russian clinical trials market.

    Clinical Trials in Kazakhstan:  A long time has passed since Western pharmaceutical and biotechnology companies began exploring other counties as locations for conducting clinical trials. The worldwide map of possible locations is expanding almost on a daily basis - In addition to traditional “emerging market players”, such as Eastern European countries and Russia, other former USSR countries have entered the game, and among them Kazakhstan, a large country with great potential in this area. Anna Ravdel will discuss Kazakhstan's regulatory and logistics environment, site qualification and PI training challenges, and how Kazakhstan can deliver on a clinical trial though high quality, high speed, and low costs.

    Legal and Organizational Details of the Clinical Trial Application Process in Russia: Evgeny Rogov will present an overall picture of the study application in Russia from the official point of view, and explain in detail the step-by-step process of the clinical trial application. Mr. Rogov will cover required legal documents and timelines, providing concrete examples of the forms and documents as well as typical errors and possible bottlenecks.

    Please join us for a unique opportunity to learn about the challenges of the Russian regulatory environment from a high ranking Ministry of Health executive.

    THIS PROGRAM IS INTENDED FOR:
    • Senior level executives involved in the decision making process for clinical trials placement/location
    • Project Managers and Regulatory Managers who are or will be involved in conducting clinical trials in Russia, Kazakhstan or Eastern Europe

    For pharmaceutical and biotechnology companies

    ABOUT OUR SPEAKERS

    Evgeny (Eugene) Rogov, MD, PhD, JD,
    Deputy of Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)

    Dr. Evgeny Rogov received his Medical degree and PhD in Public Health from the Russian State Medical University and his Juris Doctor degree from the Lomonosov Moscow State University. Currently Dr. Rogov is a Deputy of Head of Clinical Trials Control Department, Federal Service for Surveillance in Healthcare and Social Development (ROSZDRAVNADZOR).

    Before this position, Dr. Rogov was Secretary of Ethic Committee of Russian State Medical University (Moscow) from 2001 (a full-board member of this committee from 2003) and a Member of Federal Ethic Committee of Russian Federation (Ethic Committee by Federal service on surveillance in healthcare and social development of Russian Federation) from 2007 to 2010. From 2006 to 2009 he was Head of Department of Innovations in Russian State Medical University (Moscow). From 2008 – a Board Member of Western IRB (Olympia, WA, USA).

    Igor Stefanov, Director, General Manager, Synergy Research Group

    As General Manager, Mr. Stefanov is responsible for providing leadership that positions the company at the forefront of the clinical trial industry in Russia. With more than 15 years of experience in business consulting and general management, Mr. Stefanov has focused his energies on developing strategic plan to advance the company's mission and objectives and to promote revenue, profitability and growth of Synergy Research Group as an organization. Igor oversees company operations to ensure production efficiency, quality, service, and cost-effective management of resources.

    Prior to joining Synergy Research Group in January 2007, Mr. Stefanov was General Manager of Smartlock, the Russian biometric company and was recognized as Entrepreneur of the Month by the Russian edition of Forbes magazine in May 2005. With an MBA in Economics and a strong local expertise Mr. Stefanov has been providing business consulting services to large multi-national companies including Pfizer, J&J, GlaxoSmithKline, F.Hoffmann-La Roche and others in Russia since 1993.

    Anna Ravdel, Director of Business Development, Synergy Research Group

    Anna Ravdel graduated from the University of Manchester with an MBA degree, and worked as a marketing and sales director in various international companies. Prior to joining SynRG, Ms. Ravedel worked as a Director of Business Development at Evidence Clinical and Pharmaceutical Research (Russia/USA), and Director of Business Development, Eastern Europe, at a global CRO Worldwide Clinical Trials.

    In her current position, Ms. Ravdel’s responsibilities include elaboration of business development strategies, including development of key goals and methods to achieve them. In cooperation with operational departments, Ms. Ravdel is in charge of development of budget and proposal tools to meet client needs, as well as mechanics for minimization of turnaround time from request for proposal to ready-to-send document. Ms. Ravdel also works out marketing programs, including web-site content and update policy, participation in trade-shows, publishing in professional journals, and creation of advertisement policies.

    WEBINAR SERIES

    Part 1 – Russia: Understanding the Regulatory Environment, Challenges & Benefits
    March 13, 2012 (archive available)
    Click here for more information

    Part 3: Cutting the Cost of Clinical Research: The Solution Comes from Russia
    February 25, 2013 (archive available)
    Click here for more information

    Part 4 – Regulatory Affairs: The Key to Russia
    April 10, 2013 (archive available)
    Click here for more information

    OUR  XTALKS PARTNER FOR THIS EVENT

    Synergy Research Group (SynRG™) is a leading Russian Contract Research Organization (CRO) successfully assisting pharmaceutical and biotechnology companies, as well as global CROs in conducting clinical trials in Russia and the Commonwealth of Independent States (CIS) since 2002.

    SynRG was established as an answer to the growing demand for clinical trials in Eastern Europe. We are committed to provide high quality services capitalizing on our in-depth knowledge of international and local regulations, long-term relationships with central and peripheral medical institutions, and a broad network of investigators with vast clinical research experience in various therapeutic areas.

    SynRG is a client-oriented company with emphasis on true partnership relations with the client. Our collaborative effort is based on a mutual respect for one another's expertise, knowledge, and skills; through close cooperation we eliminate territorial issues, communicate efficiently and work proactively among team members to ensure success of the project. With SynRG you will feel like our only client!

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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