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2022-07-13

Experts of Raevsky clinics: oncopsychology is necessary in cancer treatment

On June 30, 2022, an online conference "Treatment of oncology with integrative methods" was held as part of the All-Russian Scientific and Educational Project. It was conducted by the staff of Dmitry Raevsky's network of integrative medicine clinics. They spoke about the need to include oncopsychology in the complex treatment of oncological diseases.

2022-07-01

Moscow hosted the 9th annual conference "Health Technology Assessment", dedicated to improving the drug supply strategy

In the new economic conditions, the issue of increasing the efficiency of organizing and financing the healthcare system to ensure the quality and accessibility of medical care both at the federal and regional levels is extremely acute. 

 

2022-06-02

Results of the V Annual All-Russian Scientific and Practical Conference with International Participation "Safety of Pharmacotherapy: Noli nocere!"


On May 19, 2022, the V Annual All-Russian Scientific and Practical Conference with international participation “Safety of Pharmacotherapy: Noli nocere!” was held at the RMANPE, which was held as part of the XIII All-Russian Meeting “Actual Issues of Clinical Pharmacology and Drug Supply”.

 

2022-06-01

IX INTERNATIONAL SCIENTIFIC AND PRACTICAL CONFERENCE "HEALTH TECHNOLOGY ASSESSMENT: IMPROVING THE DRUG SUPPLY DEVELOPMENT STRATEGY"


On June 21-22, 2022, Moscow will host the IX International Scientific and Practical Conference "Health Technology Assessment: Improving the Strategy for the Development of the Drug Supply System".

 

2022-05-19

Innovative doctors at a free conference will talk about psychotherapy in the treatment of oncology

The free online conference "Psychotherapy in Oncology" will be held on May 26.

 

2022-04-27

Russian Pharmaceutical Forum named after Semashko: the main meeting place for the pharmaceutical market acquires a new name

The Russian Pharmaceutical Forum has been the main platform for meeting the entire Russian pharmaceutical market and discussing the most pressing and pressing issues of the pharmaceutical industry for 28 years. The rich history of the Forum and the challenges that the national drug supply system is currently facing turned the attention of the Forum organizers to the historical experience of building and forming a unique model of the national healthcare system built by the outstanding healthcare organizer Nikolai Semashko.

2022-04-15

Overuse of short-acting beta-2-agonists in bronchial asthma in Russia

The international scientific journal Journal of Asthma and Allergy published an article "SABA abuse in Russia - burden and possible causes: analysis of the Russian population included in the SABINA III study", which highlights the results of a study of real clinical practice of Russian patients with bronchial asthma (BA), receiving therapy with SABA (short-acting beta-2-agonists). The study showed that in Russia there is a high level of excessive prescription of SABA, which may be correlated with the problem of inadequate control of the course of bronchial asthma and the occurrence of frequent severe exacerbations. The frequency of SABA overuse was not associated with disease severity.

2022-04-15

A systematic review of real-world clinical practice data in COVID-19: non-interventional studies

As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research.

2022-04-14

CONFERENCE “REAL-WORLD DATA IN A CHANGING WORLD. CHALLENGES AND SOLUTIONS” IN SEPTEMBER 2022

The Association of Specialists in the Field of Health Technology Assessment, the Association of Clinical Pharmacologists, the St. Petersburg Division of the International Society for Pharmacoeconomic Research and Scientific Analysis - ISPOR express their deep respect and invite you to accept participation in the work of the III annual scientific and practical RWD / RWE conference: “Real-world data in a changing world. Challenges and Solutions”, which will take place in September 2022, on September 15 or 22.

2022-04-12

On April 18-19, the conference "Actual issues of preclinical and clinical trials of drugs and clinical trials of medical devices" will be held

First St. Petersburg State Medical University named after Academician I.P. Pavlov invites you to take part in the IX All-Russian Conference with international participation "Actual issues of preclinical and clinical trials of drugs, biomedical cell products and clinical trials of medical devices", which will be held in St. Petersburg on April 18 and 19, 2022.

2022-04-01

Symposium dedicated to the 80th anniversary of the birth of Professor, Corresponding Member of the Russian Academy of Sciences, Yuri Borisovich Belousov

04/04/2022 from 12:15 - 15:00 immediately after the Grand Opening of the Congress and the Report of the President of the Congress Alexander Chuchalin, a SYMPOSIUM DEDICATED TO THE 80TH ANNIVERSARY OF THE BIRTH OF PROFESSOR, CORRESPONDING MEMBER OF THE RAS, YURI BELOUSOV

 

2022-03-30

The concepts of RWD and RWE are officially introduced in the EAEU

Within the framework of the Eurasian Economic Union (EAEU), since March 27, 2022, the concepts of "real-world data" (RWD) and " real-world evidence" (RWE) have been officially introduced.

2022-03-09

ISPOR Launches “About Real-World Evidence” Content

The Professional Society for Health Economics and Outcomes Research (HEOR) in partnership with the Bristol Myers Squibb-Pfizer Alliance announced that it has launched a new “About Real-World Evidence” microsite. This introductory content is designed for the broader healthcare audience toward the goal of engaging healthcare professionals in advancing best practices for the use of real-world evidence (RWE) in clinical decision making.

2022-02-17

EU ramps up collection of public health data to improve drug reviews

The European Medicines Agency has set up a new centre to collect and mine more public health data from EU member states to improve the review of new drugs and provide them more quickly to patients.

2022-02-05

NICE signals commitment to greater flexibility in its evaluation of promising new health technologies and making patient access fairer

Changes to the way medicines and other health technologies are evaluated by NICE for use in the NHS were approved by its Board 19 January 2022.

2022-01-20

RWD as a tool for making decisions when making changes regarding the safety / efficacy of a medicinal product in the instructions for medical use and during registration

Please, see the report by "RWD as a tool for making decisions when making changes regarding the safety / efficacy of a medicinal product in the instructions for medical use and during registration", V. Merkulov, Deputy General Director of the Federal State Budgetary Institution "NCESMP" of the Ministry of Health of Russia, MD, Professor.

2022-01-20

Assessment of the prospects and barriers to the use of electronic medical records as a source of data for real clinical practice

Please, see the report by "Assessment of the prospects and barriers to the use of electronic medical records as a source of data for real clinical practice", Gusev AV, Director of Business Development, Ph.D., Webiomed.

2022-01-20

Technologies of personalized medicine: the view of a clinical pharmacologist

Please, see the report by "Technologies of personalized medicine: the view of a clinical pharmacologist", DA Sychev, Head of the Department of Clinical Pharmacology and Therapy, Rector of the RMANPO of the Ministry of Health of the Russian Federation, Doctor of Medical Sciences, Professor Corresponding Member of the Russian Academy of Sciences

2022-01-11

RWD / RWE and pediatric routine - is there a connection?

Please, see the report by "RWD / RWE and pediatric routine - is there a connection?" Namazova-Baranova L.S., President of the Union of Pediatricians of Russia, Head of the Department of Faculty Pediatrics, Faculty of Pediatrics, N.I. Pirogov of the Ministry of Health of Russia, Chief Freelance Specialist for Children in Preventive Medicine of the Ministry of Health of Russia, Professor, Doctor of Medical Sciences, Academician of the Russian Academy of Sciences.

2022-01-11

Impact of the COVID-19 pandemic on microbial resistance in the Russian Federation

Please, see the report by "Impact of the COVID-19 pandemic on microbial resistance in the Russian Federation", RS Kozlov, Corresponding Member of the Russian Academy of Sciences, Professor, Doctor of Medical Sciences, Rector of the Smolensk State Medical University of the Ministry of Health of the Russian Federation. Chief freelance specialist of the Ministry of Health of the Russian Federation in clinical microbiology and antimicrobial resistance. Head of the WHO Collaborating Center for Strengthening Capacity in Antimicrobial Resistance Surveillance and Research.

2022-01-11

Digital technologies in assessing the practice of drug use

Please, see the report by "Digital technologies in assessing the practice of drug use", Khokhlov AL, Head of the YSMU Department of the Ministry of Health of Russia, Chief Clinical Pharmacologist of the Yaroslavl Region and the Central Federal District of the Russian Federation, Professor, Doctor of Medical Sciences, Corresponding Member of the Russian Academy of Sciences.

2022-01-11

RWD in the paradigm of clinical guidelines

Please, see the report by "RWD in the paradigm of clinical guidelines", O. Sukhorukikh, Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation

2021-12-30

AIPM RWE Working Group

Please, see the report by «AIPM RWE Working Group», T. Goldina, Head of Real Clinical Practice Data and Scientific Communication, Sanofi

2021-12-29

Research of real clinical practice in the field of Pulmonary arterial hypertension

Please, see the report by "Research of real clinical practice in the field of Pulmonary arterial hypertension", Ryazhenov V.V., Head of the Department of Regulatory Relations in the field of circulation of medicines and medical devices of the First Moscow State Medical University named after THEM. Sechenov. "

2021-12-29

Problems of including RWD / RWE data in the justification for registration of a medicinal product

Please, see the report by "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, Department of Technical Regulation and Accreditation

2021-12-29

RWD / RWE real experience 2020

Please, see the report by "RWD / RWE real experience 2020", Samsonov M.Yu., Director of the medical department "R-Pharm"

2021-12-24

Digital solutions for collecting and analyzing data from real clinical practice - advantages and barriers

Please, see the report by “Digital solutions for collecting and analyzing data from real clinical practice - advantages and barriers”, Leer M., Head of Research and Medical Projects Group, Takeda

2021-12-24

Prospects for the implementation of the institute for research of real clinical practice data in the context of the EAEU

Please, see the report by "Prospects for the implementation of the institute for research of real clinical practice data in the context of the EAEU", V. Kukava, Executive Director, Association "Infarma"

2021-12-24

A systematic approach to assessing real clinical practice is the most important tool for developing competition in the pharmaceutical market

Please, see the report by "A systematic approach to assessing real clinical practice is the most important tool for developing competition in the pharmaceutical market", T.V. Nizhegorodtsev, Deputy Head of the Federal Antimonopoly Service of Russia.

2021-12-21

Review of research in real clinical practice on the example of spinal muscular atrophy

Please, see the report by "Review of research in real clinical practice on the example of spinal muscular atrophy", 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", MD, Professor.

2021-12-18

MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

This document provides an introduction to the MHRA’s real-world data (RWD) guideline series, and points to consider when evaluating whether a RWD source is of sufficient quality for the intended use.

2021-12-18

Collection and processing of RWE / RWD data in clinical trials from an IT point of view

Please, see the report by “Collection and processing of RWE / RWD data in clinical trials from an IT point of view”, O. Loginovskaya, executive director of Flex Databases.

2021-12-16

Experience in collecting and processing real clinical practice data (RWD) during the Covid-19 pandemic

Please, see the report by “Experience in collecting and processing real clinical practice data (RWD) during the Covid-19 pandemic”, TI Galimov, Executive Director of Data Management 365.

2021-12-15

Implementation of the principles of patient-centeredness in healthcare

Please, see the report by “Implementation of the principles of patient-centeredness in healthcare”, Yu.A. Zhulev, President of the All-Russian Charitable Public Organization of Disabled People “All-Russian Society of Hemophilia”.

2021-12-15

The Ministry of Health appointed the first deputy responsible for digitalization and compulsory medical insurance

Russian Prime Minister Mikhail Mishustin has appointed Vladimir Zelensky as First Deputy Minister of Health of the Russian Federation. Vladimir Zelensky graduated from the Academy of Budget and Treasury of the Ministry of Finance of Russia, is a candidate of economic sciences. He held a number of positions in the Ministry of Finance of the Russian Federation, worked in the Ministry of Health and Social Development of the Russian Federation, and also headed the Moscow City MHI Fund.

2021-12-14

RWD / RWE in the practice of an endocrinologist

Please, see the report by "RWD / RWE in the practice of an endocrinologist", Galstyan G.R., Deputy Director of the Institute of Diabetes, Head of the Department of Diabetic Foot.

2021-12-10

Current and projected approaches to regulating the collection, analysis and use of data from real clinical practice in the EAEU

Please, see the report by "Current and projected approaches to regulating the collection, analysis and use of data from real clinical practice in the EAEU", M. Borzova, Trubor Law Office.

2021-12-09

Epidemiological characteristics of diabetes mellitus in the Russian Federation: clinical and statistical analysis according to the Federal diabetes register data of 01.01.2021

One of the priority directions in the development of the health care system is to reduce the medical and social damage caused by the increase in the prevalence of diabetes mellitus (DM). From this point of view, the development of a diabetes register is very important as the main information and analytical platform for clinical and epidemiological monitoring of diabetes in the Russian Federation (RF).

2021-12-09

ISPOR RWE Initiative

Please, see the report by "ISPOR RWE Initiative", Prof. Richard Willke, ISPOR Chief Science Officer

2021-12-09

Pharmaceutical industry experts on trends in clinical trials

Changes to the EAEU rules, which introduce the concepts of RWD and RWE, may be considered by the Board of the Eurasian Economic Commission at the beginning of next year. It is planned that at the first stage it will be possible to use the RWE data when making changes to the registration dossier for the drug.

2021-12-09

RWE data will be possible to use when making changes to the registration dossier for a drug in Russia

Changes to the EAEU rules, which introduce the concepts of RWD and RWE, may be considered by the Board of the Eurasian Economic Commission at the beginning of next year. It is planned that at the first stage it will be possible to use the RWE data when making changes to the registration dossier for the drug.

2021-12-07

All-Russian Scientific and Practical Conference "Ethical Problems of Artificial Intelligence Application in Health Care"

TsNIIOIZ held on November 29, 2021 a scientific and practical conference "Ethical problems of the use of artificial intelligence in healthcare", to which leading experts were invited and various aspects of the ethical development and implementation of AI in medical practice were discussed.

2021-12-07

Global Regulators Perspectives on RWD/ E

Please, see the report by "Global Regulators Perspectives on RWD/ E", Gracy Crane, International Regulatory Policy, RWD Lead, Roche

2021-12-07

Interaction between the state and business in the development of RWD / RWE in the healthcare of the Russian Federation

Please, see the report by "Interaction between the state and business in the development of RWD / RWE in the healthcare of the Russian Federation", A. Artyomov, CEO, Aston Health.

2021-12-07

The growing importance of RWE. Global Perspectives

Please, see the report by “The growing importance of RWE. Global Perspectives ”, Spannheimer A., IQVIA Senior Vice President, Global Head of Proposals, Innovation and Partnerships, Clinical Practice Practice, Germany / Vice President Clinical Operations, Clinical Practice Practice Unit, United Kingdom.

2021-12-07

CIOMS WG XIII: Real-World Data and Real-World Evidence in Regulatory Decision Making

Please, see the report by "CIOMS WG XIII: Real-World Data and Real-World Evidence in Regulatory Decision Making". Juhaeri JUHAERI, Ph.D., Head, Epidemiology and Benefit-Risk Evaluation, Sanofi.

2021-12-01

On the way to patient-centered medicine: RWD instruments

Please, see the report by "On the way to patient-centered medicine: RWD instruments", Frolov M.Yu., Head of the Laboratory of Pharmacoeconomics, Digital Medicine and Artificial Intelligence, NTSILS Volgograd State Medical University, Head of the Expert Group of the Association of Clinical Pharmacologists.

2021-11-24

An electronic recipe platform will be launched in the Kursk region

The administration of the Kursk region has decided to launch an electronic recipe platform in the Kursk region. It is expected that by the beginning of 2022 it will be possible to prescribe digital prescriptions in all public clinics in the region. The project will be launched on the Electronic Prescription platform from Medicata, and Rostelecom will become the operator of the project in the Kursk region.

2021-11-19

Real-World Data / Real-World Evidence: Role in Pharmacoeconomics and Health Technology Assessment

COLLEAGUES, as part of the XXV RUSSIAN ONCOLOGICAL CONGRESS, the 12th symposium "Pharmacoeconomics in Oncology" was held on the topic: "Real World Data / Real World Evidence (RWD / RWE): Role in Pharmacoeconomics and Health Technology Assessment" (https://rosoncoweb.ru/news/society/2021/11/15-1/).

2021-11-19

The Second Annual Scientific-Practical Conference in St. Petersburg, Russia

The Association of Health Technology Assessment Professionals, Association of Russian Clinical Pharmacologists, ISPOR Russia St Petersburg Chapter co-organized the II annual scientific-practical conference “RWD/RWE – Tools for Real Clinical Practice Research: Today and Tomorrow” on September 16, 2021. The conference brought together experts from academia, government, pharmaceutical industry, regulatory, and clinical trials from Russia and other countries to discuss about RWD/RWE. ISPOR Chief Science Officer Dr Richard Willke was invited to give a presentation on ISPOR’s RWE transparency initiative and related efforts. More than 300 people participated in this event. 

2021-11-11

The arrival of innovative personalized technologies requires a shift to value-based purchasing and pricing models

The collection of data from real-world data (RWD) is of great importance for making a decision on the inclusion of innovative personalized technologies - cell, gene therapy, complex genomic profiling (NGS-diagnostics) - in the system of state funding, noted Nuria Musina, Advisor to the Head of the Federal State Budgetary Institution "CECCMP" of the Ministry of Health Russia at the Russian Cancer Congress.

2021-11-10

Ethics Committee Guidelines "Ethical Review of Biomedical Research"

Ethics Committee Guidelines for Ethics Review of Biomedical Research released. The guide is intended for daily use by members of Ethics Committees for peer review in biomedical research; specialists engaged in such research; working in clinics, pharmaceutical companies, contract research organizations, leaders of scientific and clinical projects, representatives of regulatory bodies, research institutes, higher certification commissions. The presented material will help researchers, graduate students who plan to start or are already conducting biomedical research in accordance with international requirements.

2021-11-03

Within the framework of the XXV RUSSIAN ONCOLOGY CONGRESS will be held the 12th symposium "Pharmacoeconomics in Oncology"

Main topic - Real World Data / Real World Evidence (RWD / RWE): Role in Pharmacoeconomics and Health Technology Assessment.

2021-10-22

FORUM: Clinical Trials in Russia 2021

On November 30 - December 1, 2021, the Clinical Research in Russia 2021 forum will be held, which will discuss the registration of clinical trials according to the general rules of the EAEU, trends in the field of digitalization, the development of RWE in Russia, as well as conducting clinical trials during a pandemic.

2021-10-14

Start your week of health care with Biohacking Conference Moscow 2021!

Biohacking Conference Moscow 2021 will soon take place, where experienced biohackers, doctors and scientists will tell you how to improve health, prolong youth, achieve longevity and become the best version of yourself..

2021-10-13

Moscow schoolchildren will be tested for COVID-19 by express tests of a Skolkovo resident

In Moscow, starting tomorrow, free express testing of students for COVID-19 will begin at 10 schools. The check will be carried out every two weeks using express tests of the Rapid BIO company, a Skolkovo resident (in coordination with VEB.RF). Rapid BIO tests help to determine the probability of the presence of a virus in less than 10 minutes, the reliability of the result is 96%.

2021-09-28

Experts discuss tools for researching data from real-world practice

The II annual scientific-practical conference with international participation "RWD/RWE - Research Tools for Real Clinical Practice Today and Tomorrow" was held on September 16.

 

2021-09-02

We invite you to take part in the conference "RWD/RWE - Research Tools for Real Clinical Practice Today and Tomorrow" and the exhibition "RWD/RWE - prospects and opportunities": September 16, 2021, Moscow

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.

2021-08-17

Artificial intelligence in the field of drug circulation

The International Coalition of Medicines Regulators (ICMRA), in a published report, has outlined recommendations to help regulators address the challenges posed by the use of artificial intelligence (AI) for global drug regulation.

2021-08-15

Luteinizing hormone-releasing hormone agonists for prostate cancer patients: routine clinical practice of Russian cancer urologists

Despite the recent amendments to the guidelines for the treatment of metastatic hormone-sensitive prostate cancer (PCa) implying standard use of luteinizing hormone-releasing hormone (LHRH) agonists in combination with chemotherapy or androgen inhibitors, androgen deprivation therapy (ADT) remains an essential component of treatment for advanced PCa. Testosterone target castration level of 20 ng/dL implies routine measurement of testosterone levels along with prostate-specific antigen (PSA) levels during ADT. It is particularly interesting to evaluate the frequency of achieving castration testosterone level in routine clinical practice. 

2021-08-15

COVID-19 accelerating development & use of real-world data sources

Many challenges in using routinely collected real-world data (RWD) to support the development of health technologies exist. Few data sources have national coverage, leading to concerns regarding the extent to which findings can be generalized to a country-wide setting. In addition, governance around accessing data can also introduce significant inefficiencies and lead to prohibitively long timelines. This is a particular issue in Europe where due to the nature of the health systems, the data providers are often state or state-funded bodies rather than commercial entities. This is a key hurdle in the context of initial health technology assessment (HTA), where the timeframe for generation of RWD is typically limited to the period between obtaining positive trial results and the time of HTA consideration.

2021-08-15

US FDA approves new Prograf use, supported by real-world evidence

The US FDA has announced its approval of tacrolimus (brand name Prograf) for use in combination with other immunosuppressant drugs to help prevent organ rejection in adult and pediatric populations receiving lung transplants. The approval is significant as it was supported by real-world evidence from an observational study of the effectiveness of the drug for the new use.

2021-08-15

Preparing for the season of acute respiratory viral infections

The season of acute respiratory viral infections and influenza is just around the corner! Let's figure out how to treat this disease?

2021-08-12

Causes, Predisposing Factors and Prevention Directions of Drug-induced Bradycardia (Based on the Results of the Hospital Register of Oardiac Medications Overdoses STORM)

Analysis of drug-induced bradiarrhythmia (DIB) causes and predisposing factors, followed by the development of recommendations for practitioners on its prevention.