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.

The results of previous conferences on this topic confirmed the relevance of the chosen scientific and practical direction. Delegates from the Russian Federation, countries of near and far abroad (the Republic of Belarus, the Republic of Kazakhstan, Armenia, Italy, Ukraine, France, Germany, the Netherlands, the USA) took part in the work of the forum in previous years. Russian participants represented Russian cities from different regions (Moscow, St. Petersburg, Volgograd, Tver, Kazan, Rostov, etc.). Among the active participants of the conference were representatives of pharmaceutical companies, government educational and scientific institutions, ethics committees, administrative and regulatory bodies, contract research organizations and insurance companies.

Each time following the results of the conference, representatives of regulatory authorities in the field of circulation of medicines and medical devices expressed their opinion on the high efficiency and fruitfulness of the event and pointed out the need to hold the conference on a regular basis.

Within the framework of the IX conference, it is planned to continue discussing issues related to topical issues of preclinical and clinical trials of drugs, biomedical cell products and clinical trials of medical devices, gene therapy and genome editing, immunoprophylaxis of respiratory infections, modern approaches to assessing data from real clinical practice, the state of pharmacovigilance, issues precision medicine, digitalization of clinical trials and trials, high-quality statistical practice, the problem of accelerated registration of medicines with breakthrough efficiency and early access to them. The assessment of the current state of clinical research in pediatrics, psychiatry and narcology deserves special attention. The platform of the proposed forum based on the experience of previous conferences is optimal for discussion of these issues by the professional community with the participation of the regulator.

Format of the conference for listeners:

The plenary session and the visiting session of the Council on Ethics of the Ministry of Health of Russia will be held in a classroom format with online broadcast.

The symposiums will be held in a hybrid mode with online broadcast on the platform https://webinar.ru, in-person attendance is provided for speakers and moderators of the symposiums. For listeners, full-time presence is possible only by agreement with the organizing committee.

Venue of the conference: FSBEI HE PSPbGMU im. I.P. Pavlov of the Ministry of Health of Russia, St. Petersburg, st. Leo Tolstoy, d. 6-8 (buildings 1, 2, 4).

Conference organizers:

• Ministry of Health of the Russian Federation
• FSBEI HE "First St. Petersburg State Medical University named after academician I.P. Pavlova"
• FSBI National Medical Research Center named after V.A. Almazov"
• Federal State Budgetary Scientific Institution "Research Institute of Pharmacology named after A.I. V.V. Zakusova"
• Russian Scientific Society of Pharmacologists
• St. Petersburg Branch of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 

The conference is included in the plan of scientific and practical events of the Ministry of Health of Russia for 2022 (Order No. 1216 dated December 30, 2021).

Conference working hours:

Monday, April 18, 2022

09:30 – 12:30. Plenary session (Hall of the Academic Council)

13:00 - 16:00. Symposia. Day session.

• Symposium No. 1 "Preclinical evaluation of drug safety: reality and trends" (Hall of the Academic Council)
• Symposium №2 "Pharmacovigilance" (Scientific Council Hall)
• Symposium No. 3 "Organization and conduct of preclinical studies of specific activity" (room No. 5)
• Symposium No. 4 “Risk-Based Approach in Planning Preclinical and Clinical Research. Issues of medical rating, quality assurance, project management” (Rector’s Office Hall No. 1)

16:00-18:00. Meeting of the Ethics Council of the Ministry of Health of Russia (Academic Council Hall)

Tuesday, April 19, 2022

10:00 - 13:00. Symposia. Morning session.

• Symposium №5 "Gene and Cell Therapy" (Hall of the Academic Council)
• Symposium No. 6 "Collective Research Data Collection and Processing" (Scientific Council Hall)
• Symposium No. 7 "RWD/RWE: Real Clinical Data" (Rector's Office Hall No. 1)

14:00 - 17:00. Symposia. Day session.

• Symposium №8 "Data Modeling in Clinical Research" (Scientific Council Hall)
• Symposium No. 9 "Peculiarities of conducting preclinical and clinical studies in pediatric oncology and hematology" (Hall of the Academic Council)
• Symposium No. 10 "Clinical research in infectology" (room No. 5)
• Symposium No. 11 "Clinical research in pediatrics" (Rector's office room No. 1)
• Symposium No. 12 "Actual issues of clinical research in psychiatry and narcology" (Rector's office room No. 2)

The work plan of the conference includes a plenary session, an off-site meeting of the Ethics Council of the Ministry of Health of Russia, 12 thematic symposiums. The conference program will be published on the website of the St. Petersburg State Medical University. acad. I.P. Pavlova www.1spbgmu.ru.

Heads of health authorities of the subjects of the Russian Federation, heads of medical and educational institutions involved in the organization and implementation of preclinical and clinical trials of medicines, clinical trials of medical devices, researchers, members of local ethical committees, representatives of pharmaceutical companies, companies - manufacturers of biomedical cell products and medical devices, contract research organizations.

Contact details of the Conference Organizing Committee:

FGBOU VO PSPbGMU im. I.P. Pavlov of the Ministry of Health of Russia, St. Petersburg, st. Leo Tolstoy, 6-8, www.1spbgmu.ru 

Executive Secretary Dey Galina Germanovna, (812) 338-6617; e-mail: gal-dej@yandex.ru 

https://www.1spbgmu.ru/nauka/konferentsii/5942-18-19-aprelya-sostoitsya-konferentsiya-aktualnye-voprosy-doklinicheskikh-i-klinicheskikh-issledovanij-lekarstvennykh-sredstv-biomeditsinskikh-kletochnykh-produktov-i-klinicheskikh-ispytanij-meditsinskikh-izdelij 

Participation in the conference is free.

To participate in the Conference, you need to get a link to access the conference as follows:

Create a personal account on the Prima Loko LLC website (when creating a personal account, you must confirm your email address).
In your personal account, select the conference you are interested in from the list, click the "Register" button and confirm your online participation.
After registration, you will see this conference in the "My registrations" section of your personal account.