 | Association of Health Technology Assessment Professionals, Association of Clinical Pharmacologists, St. Petersburg Branch of the International Society for Pharmacoeconomic Research and Scientific Analysis - ISPOR would like to express our deep respect to you and invite you to take part in the conference “RWD/RWE - Research Tools for Real Clinical Practice Today and Tomorrow”, Which will start at 9:30 am, September 16, 2021. |
The plenary session will discuss the tasks, current state, best world and domestic practices in the study of real clinical practice data (RWD) and their analysis (RWE). As part of the panel discussion, leading experts in the field of clinical research, healthcare organizations and high technologies will answer the most pressing questions that concern the medical community in the development of RWD / RWE in Russia. It is also planned to discuss the practical experience of healthcare professionals and representatives of scientific organizations in the field of RWD/RWE. The conference will be attended by leading experts in the field of clinical trials, health technology assessment, pharmacovigilance, pharmacoeconomics, practical health care, experts in the field of "Big Data", representatives of public and patient organizations, the pharmaceutical industry, the Ministry of Health of the Russian Federation, legislative and executive authorities, and also representatives of international organizations ISPOR, etc. The conference will be held at the Novotel Moscow Kievskaya hotel at the address: Moscow, st. Kievskaya, 2. For the convenience of the participants, an online broadcast will be provided. The technical organizer of the conference is Aston Consulting JSC. THEME "RWD/RWE - Research Tools of Real Clinical Practice Today and Tomorrow" The conference will demonstrate the relevance of collecting data from the real clinical world, as well as discuss the need to amend the current legislation in order to use RWD/RWE in clinical practice. ABSTRACTS - Real clinical data and its analysis (RWD/RWE) is a modern request of the healthcare system, the interest in which has grown significantly over the past years in most countries of Europe and the USA.
- The RWD/RWE topic is currently of great importance, since it helps to solve the problems of practical health care from the point of view of pharmacoeconomics, which makes it possible to rationally allocate limited resources, to plan activities with the lowest cost of funds. Thus, by influencing health policy, the RWD/RWE concept protects the public interest.
- The conference will be attended by leading experts in the field of pharmacoeconomics, practical health care, representatives of public and patient organizations, representatives of the Ministry of Health of the Russian Federation, legislative and executive authorities.
Participants: Plenary session: 9.30-11.35 | Introductory remarks, moderation | Kolbin A.S. | Head of the Department of Clinical Pharmacology and Evidence-Based Medicine of the First St. acad. I.P. Pavlova, MD, DSc, Professor | | Introduction | Petrov V.I. | President of Volgograd State Medical University, Doctor of Medical Sciences, Professor, Academician and Member of the Presidium of the Russian Academy of Medical Sciences, Academician of the Russian Academy of Sciences, Head of the Department of Clinical Pharmacology, Chief Freelance Specialist of the Ministry of Health of the Russian Federation | | The topic of the report is being specified | Glagolev S.V. | Deputy Minister of the Ministry of Health of the Russian Federation | | Evidence from real-world clinical studies in the clinical guideline paradigm | Omelyanovsky V.V. | General Director of the Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation, Clinical Pharmacologist, Doctor of Medical Sciences, Professor | | A systematic approach to assessing real clinical practice is the most important tool for developing competition in the pharmaceutical market | Nizhegorodtsev T.V. | Deputy Head of FAS Russia | | Problems of including RWD / RWE data in the justification for registration of a medicinal product | Rozhdestvensky D.A. | Eurasian Economic Commission
Head of the Department for Coordination of Work in the Sphere of Circulation of Medicines and Medical Devices of the Department of Technical Regulation and Accreditation | | RWD as a decision-making tool when making changes regarding the safety / efficacy of a drug and when registering it for medical use | Merkulov V.A. | Deputy General Director of the Federal State Budgetary Institution "NTsESMP" of the Ministry of Health of the Russian Federation | | Panel discussion - methodology and decision making 11: 45-13: 25 | | Impact of the COVID-19 pandemic on microbial resistance in the Russian Federation | Kozlov R.S. | Corresponding Member of the Russian Academy of Sciences, Professor, Doctor of Medical Sciences, Director of the Research Institute of Antimicrobial Chemotherapy, Smolensk State Medical Academy, President of the Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy (IACMAC) | | Global Regulators Perspectives on RWD/E | Gracy Crane | International Regulatory Policy, RWD Lead, Roche | | Personalized Medicine Technologies: A Clinical Pharmacologist's Perspective | Sychev D.A. | Head of the Department of Clinical Pharmacology and Therapy, RMANPO, Ministry of Health of the Russian Federation, Doctor of Medical Sciences, Professor, Corresponding Member of the Russian Academy of Sciences | | The topic of the report is being specified | Namazova-Baranova L.S. | President of the Union of Pediatricians of Russia, Head of the Department of Faculty Pediatrics of the Pediatric Faculty N.I. Pirogov of the Ministry of Health of the Russian Federation, Chief Freelance Specialist for Children in Preventive Medicine of the Ministry of Health of the Russian Federation, Professor, Doctor of Medical Sciences, Academician of the Russian Academy of Sciences | | The growing importance of RWE. Global Perspectives | Spannheimer A., Blackwood M. | IQVIA Senior Vice President, Global Head of Proposals, Innovation and Partnerships, Real Estate Clinical Practice, Germany / VP Clinical Operations, Real Estate Clinical Practice, United Kingdom | | Reports: 13.35-14.50 | | Legal issues | Borzova M. | Counselor of the Trubor Law Office | | Digital technologies in the assessment of drug use practice | Khokhlov A.L. | MD, professor, Corresponding Member RAS, Head of the Department of Clinical Pharmacology, Yaroslavl State Medical Academy, Yaroslavl | | Pharmacokinetic studies in real practice as a tool for optimizing dosage regimens | Zyryanov S.K. | Head of the Department of General and Clinical Pharmacology, Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Doctor of Medical Sciences, Professor | | RWD as the basis of the platform of the Federal Project "Digital Technologies" | Artyomov A.V. | CEO of Aston-Health | Panel discussion - experience: 15.00-16.20 | | RWD / RWE real experience 2020 | Samsonov M.Yu. | Director of the Medical Department "R-Pharm" | | Identification of suspicions of orphan diseases based on the analysis of data from electronic medical records | Leer M. | Research and Medical Project Team Leader, Takeda | | Prospects for the implementation of an institute for researching data from real clinical practice at the EAEU level | Kukava V. V. | Executive Director of the Association of the world's leading innovative pharmaceutical companies "Infarma" | | ISPOR RWE Initiative | Prof. Richard Willke | ISPOR Chief Science Officer | | Closing session: 16.30-18.00 | | Development of personalized medicine in the Russian Federation, the role of real clinical practice data | Moretskaya V. | Business Leader Personalized Medicine and Integrated Genomic Profiling, Roche | | Assessment of the prospects and barriers to the use of electronic medical records as a source of data from real clinical practice | Gusev A.V. | Business Development Director, Ph.D., "Webiomed" | | Experience in collecting and processing real clinical practice data (RWD) during the COVID-19 pandemic | Galimov T.I. | Data Management 365 Executive Director | | AIPM RWE Working Group | Goldina T. | Sanofi Real Clinical Practice and Scientific Communication Data Manager | | Implementation of the principles of patient orientation in health care | Zhulev Yu.A. | President of the All-Russian Charitable Public Organization of the Disabled "All-Russian Society of Hemophilia" | | Towards Patient-Oriented Medicine: RWD Tools | Frolov M.Yu. | Head Laboratory of Pharmacoeconomics, Digital Medicine and Artificial Intelligence NCILS Volga State Medical University, Head of the Expert Group of the Association of Clinical Pharmacologists | Общая дискуссия |
Participants: Participation for individuals is free, there will also be an online broadcast for registered participants. Register To sponsors For questions related to the organization of the event, sponsorship and / or participation, please contact Alexander Ivanov, a.ivanov@aston-health.com, +7 (916) 669-73-39. |
