WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Russia: Understanding the Regulatory Environment, Challenges & Benefits
March 13, 2012
|Speakers for this Event:
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy of Head of Clinical Trials Control Department,|
Federal Service for Surveillance in Healthcare and Social Development
Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
This first webinar in our series will examine the advantages and disadvantages of conducting clinical trials in Russia, the clinical studies cycle, regulatory environment, and impact of the new Drug Law in Russia on the clinical trials.
What do companies look for when considering conducting their clinical trials in emerging markets? The most common answer is high quality, high speed, and low costs.
Why Russia? We will discuss why the "Russian Troika" makes Russia 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 meets the challenge by combining these three basic qualities in clinical trials
Regulatory environment (Drug Law of September 10, 2011): We will discuss the influence of the Drug Law on the clinical trials market in Russia and review basic changes from the old law. Special attention will be paid to registration and bio-equivalence studies, as well as the new insurance rules which have been modified since the Law went into effect in 2011.
New Law No. 323-FZ (the fundamentals of protection of public health): We will discuss this law how it affects the marketing approaches being taken by pharmaceutical companies.
Russia as a case study: At the end of the webinar we will review and discuss the results the 2011 clinical trials market in Russia (Orange Paper).
Please join us for a unique opportunity to learn about the challenges on 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
For pharmaceutical and biotechnology companies
||Evgeny (Eugene) Rogov, MD, PhD, JD,|
Deputy of Head of Clinical Trials Control Department,
Federal Service for Surveillance in Healthcare and Social Development (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.
|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 email@example.com