Market authorization in Russia | R&D and clinical trial regulations | state tenders | commercial value
俄罗斯上市许可|当地研发和临床试验法规|国家招标 |商业价值
俄罗斯上市许可|当地研发和临床试验法规|国家招标 |商业价值
June 20, 2024
9:30-13:00
Kerry Hotel Pudong
Shanghai, China
5-minute walk from CPHI China
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Russia-China Pharmaceutical Cooperation Forum 2024
The Pharmaceutical Research Forum 2024 aims to strengthen comprehensive strategic cooperation between China and Russia in the context of conducting clinical trials, market authorization and import and export of medicines. The conference will include, but not limited to: introduction to new marketing opportunities, state tenders, mandatory requirements for drug development, GMP inspections in Russia, regulatory authorities’ perspective on partnerships, and a detailed breakdown of why Eastern Europe has been the top-ranking region for patient enrollment over the past decade.
Description:
With the participation of:
Regulatory authorities
Decision makers
С-Suite executives
Pharmaceutical companies
Keynote Speakers
Eugenia Radkova
Head of MedSci Consulting and ExcellenceTM Department, MD, PhD
OCT Rus
Roman Ivanov
Director of the Scientific Center for Translational Medicine, Vice-Rector for Scientific and Technological Development
Sirius University of Science and Technology
Alla Trapkova
Deputy General Director, PhD in Biological Sciences
“Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of Russia
Kirill Kaem
Deputy Chairman for Innovations, Chief Managing Director
Skolkovo Foundation
Irina Petrova
Director of Clinical Operations
OCT Rus
Arina Privalova
Strategy Development Director
Nanolek
Aisylu Kamaletdinova
Deputy Director of the Department of Drug Supply and Regulation of Circulation of Medical Devices
Ministry of Health of the Russian Federation
Natalya Malykh
Vice President for Business Development
Pharmasyntez
Victoria Galkovskaya
Deputy Head
Federal Service for Intellectual Property
Dr. Shun Luo
Chairman and President
Thousand Oaks Biologics and JS Biosciences Co., Ltd.
Ekaterina Prieszheva
The Deputy Minister of Industry and Trade of the Russian Federation
Ministry of Industry and Trade of the Russian Federation
Kayla (Yuan) Xue
Partner
LSV capital
Vladislav Shestakov
Director of the State Institute of Drugs and Good Practices
Ministry of Industry and Trade of the Russian Federation
Kira Zaslavskaya
R&D Director
Promomed
Liu Wei
Secretary General of the Russian Institute, Tsinghua University, Director of the Chinese Russian Center for Standardization and Technologies Transfer Center in Healthcare
II Russian-China Pharmaceutical Cooperation Forum
June 20, 2024, Shanghai, China
Registration, Welcome Coffee
Session 1
Fundamentals of Industrial Collaboration Between Russia and China: Strategic Aspects of Cooperation
Fundamentals of Industrial Collaboration Between Russia and China: Strategic Aspects of Cooperation
Coffee Break
Session 2
Practical Aspects of Cooperation
Practical Aspects of Cooperation
Pitch sessions presented by pharmaceutical companies from Russia and China:
- OCT Rus
- JSBio
- Chemrar
- Promomed
- BioEngine
- SinoArch
Session 3
Pitch Sessions
Pitch Sessions
Coffee Break
8:30-9:30
9:30-11:00
- The Russian pharmaceutical market: regulatory system, mechanisms and the “Pharma-2030” strategy;
- Current needs of local markets for medicines, technological solutions, raw materials and components for their production;
- Key aspects of state regulation of medicines in the Russian Federation;
- Regulatory aspects of localization of Chinese drug manufacturers in Russia;
- Interaction in the field of innovative pharmaceuticals;
- Harmonization of the requirements for conducting clinical trials established by the legislation of the member states of the Eurasian Economic Union with the requirements of the EMA and FDA;
- Intellectual property protection in the pharmaceutical field in Russia and China: general and specific approaches;
- Preparation of the registration dossier and the procedure for obtaining the GMP certificate of the Eurasian Economic Union.
11:00-11:30
- Practical solutions to overcome barriers to entry of foreign pharmaceutical products into the Russian market.
- Current regulatory requirements for clinical trials and registration of drugs in Russia;
- Practical aspects of planning and conducting international and local clinical trials in Russia;
- Preparation of the registration dossier and the procedure for obtaining the GMP certificate of the Eurasian Economic Union;
- Issues of transfer of high-tech drugs;
- Ways to expand cooperation between Chinese and Russian pharmaceutical companies in the field of biotechnological drugs, including biological medicines and Advanced therapy medicinal products (ATMPs);
11:30-13:00
13:15-14:00
13:00-13:15
Organizers
Corporate Communications
Event management, consulting and marketing holding
OCT Rus
A leading contract research organization in Eastern Europe
Past conferences overview
Russia-China Pharmaceutical Cooperation Forum 2023
Media coverage
Binnopharm group
JSBio
BioEngine
Center for Healthcare Quality Assessment and Control of the Ministry of Health of Russia
FSBI ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of Russia
LSV Capital
Federal Antimonopoly Service
Ministry of Industry and Trade
of the Russian Federation
With the participation of:
Key Partners and Sponsors
Platinum Partners
Partners
With the participation of:
Official Partners
JSBio
Ministry of Industry and Trade
of the Russian Federation
FSBI ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of Russia
Skolkovo Foundation
Rospatent
Pharma United
Dear organizers,
Thanks for organizing such a wonderful forum. I am writing to you for the slides presented on the forum. Really appreciate it if you could share them.
Thanks for organizing such a wonderful forum. I am writing to you for the slides presented on the forum. Really appreciate it if you could share them.
It is very, very important to come here, especially because of the high-rank level of speakers and decision makers on the panels. This event will definitely strengthen comprehensive strategic cooperation between businesses in China and Russia within the context of conducting clinical trials, market authorization, import and export of medicines.
With this forum held successfully, we learned a lot of market information about China and Russia. Thanks for your efforts!
OCT Rus
Pharma representative
Alex Sun, Corporate Strategy,
CStone Pharmaceuticals
CStone Pharmaceuticals
Commendations from participants
Attend the Pharmaceutical Research Forum 2024 in Shanghai!
DON'T MISS A THING!
Register and interact with distinguished national and international speakers. Discover new opportunities and comprehensive strategic partnerships and find out why Eastern Europe has been the top-ranking region for patient enrollment over the past decade.
Venue
Kerry Hotel Pudong, Level 3, Pudong Ballroom 567
1388 Huamu Road, Century Park, Pudong New Area, Shanghai
Venue address:
Have a question or request? We’re here to help!
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Organizers
info@oct-rus.ru
