This fourth webinar in our series will focus on the regulatory aspects of conducting clinical trials in Russia. The regulatory environment in Russia changes rapidly – new clinical trial regulations and restrictions are introduced almost every quarter.
Our panel of leading Russian industry and government experts will help you navigate successfully through the sea of changes. Don’t miss this unique opportunity to interact with one of the co-authors of new amendments to the Russian Federal Law on Circulation of Drugs.
The Russian Regulatory System Through the Eyes of a European Expert
Has there been an inspection of the competent bodies that regulate clinical trials in the Russian Federation? Dr. Yuri Afonchikov, Synergy’s VP for Regulatory Affairs, and former employee of regulatory authorities, will share his experience. He will discuss his experiences with European Union authorities who assessed Russian legislation for clinical trials and the activities of corresponding competent bodies. The lecturer will highlight the contradictions of the current Russian regulations in the field of clinical research and the ways to resolve these conflicts in terms of European legislation. This discussion is closely linked to the following discussion regarding the changes being made to the Federal law on the Circulation of Drugs (The Russian normative document regulating organization and conduct of clinical trials).
Preliminary Expertise of IMP Samples in Russia – To Be or Not To Be?
Since its entry into force on September 1, 2010, the federal law on the circulation of drugs does not cease to displease almost all participants of the Russian pharmaceutical market. Moreover, unfavorable modifications to the law have been made 5 times to date. Currently, the executive bodies from healthcare, professional associations and healthcare professionals are actively involved in the preparation of a new version of the law. What threatens the adoption of amendments to the law? Will there be biosimilars in Russia? How will pharmacovigilance be addressed in Russia? These topics will also be covered by Dr. Afonchikov.
Clinical Trials in Russia: Back on Track
Igor Stefanov, Synergy’s General Manager and a proponent of openness and transparency in the Russian CRO business, will analyze the current state of the clinical trial market in Russia and review the upcoming 2013 trends as well as historical data. His report will follow SynRG’s Orange Paper and will discuss how the new regulatory initiatives may affect the players and influence the future landscape of the clinical trial market in Russia. Figures and tables will provide valuable data for risk-benefit analysis and decision-making for international small and mid-size pharmaceutical and biotechnological companies.
Yuri Afonchikov, MD, PhD, Vice President, Regulatory Affairs, Synergy Research Group
Dr. Afonchikov received his medical degree at the 2-d Moscow Medical Institute n.a. Pirogov (currently – Russian State Medical University) in 1988, and his PhD degree in internal medicine and cardiology in 1993. Since 2003 Dr. Afonchikov joined the department of state quality control of medicines, medical devices and medical equipment for the Ministry of Health of the Russian Federation as a leading specialist. During 2004 and 2012 Dr. Afonchikov was working on different positions in the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) in the area of organization and control of clinical trials of drugs and medical devices. Before his voluntary termination of the state service in 2012, Dr. Afonchikov occupied the position of the Head of the Department of clinical trial control at Roszdravnadzor.
Igor Stefanov, 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. Mr. Stefanov 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.
Who Should Attend?
- Pharmaceutical and biotechnology companies (clinical research, budgeting, outsourcing and project managers)
- Contract research organizations (local and global)
- Government agencies controlling the health care and medical research costs
- Media and journalists writing on pharmaceutical market, health care and clinical research issues
- Clinical research vendors (investigators, CRAs, project managers, regulatory specialists, etc.)
- Clinical research professional associations and patient advocacy groups
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!