Pharmacovigilance. Services, science, education. The main legal acts in PV

Сентябрь 8, 2022

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Pharmacovigilance. Services, science, education. The main legal acts in PV

Содержание

2. Good Pharmacovigilance Practice (GVP) of the Eurasian Economic Union, approved by the Decision of the Council
3. Structure of National Pharmacovigilance Research Center
4. PHARMACOVIGILANCE SERVICES
5. More than 30 companies – drug manufacturers 60% - Russian manufacturers 40% - representatives of foreign
6. Experienced pharmacovigilance specialists, clinical pharmacologists, Expert Advisory Body; Responding to the Good Pharmacovigilance Practice requirements of
7. Grant from the Federal State Budgetary Institution National Medical Center for Pharmacovigilance Research Results of 2017-2018
9. Webinars
10. Literature Monitoring Program
11. QPPV Survey Data in the Russian Federation What hinders the pharmacovigilance system development in your enterprise?
12. Unique software product processing data on undesirable reactions
13. Examples of unloading from automated security data processing WHO, Rawlins&Thompson, Will&Brown, DoTS, Cramer classifications
14. Functions of Expert Advisory Body Examination of Serious Adverse Reactions Issuance of independent peer review findings
15. Our possible points of interactions Getting a membership Development of pharmacovigilance initiatives in the Russian Federation
17. Скачать презентацию

Слайд 2

Good Pharmacovigilance Practice (GVP) of the Eurasian Economic Union, approved by

the Decision of the Council of the Eurasian Economic Commission No. 87 of 03/11/2016 (entered into force on 06.05.2017)
Federal Law No. 61-FZ of April 12, 2010, About the Circulation of Medicinal Products (Chapter 13)
Law of the Ministry of Health of Russia No. 682n of 09/07/2016 “On approval of the form of the document containing the results of monitoring the effectiveness and safety of medicinal products for medical use, carried out by the holder or owner of the registration certificate of the medicinal products or an authorized legal entity”
Order of Roszdravnadzor No. 1071 of February 15, 2017 “On Approval of the Procedure for the Implementation of Pharmacovigilance”
Order of the Ministry of Health of Russia dated 07.09.2015 No. 5539 “On approval of the procedure for the implementation of selective quality control of drugs for medical use”

The Main Legal Acts in PV

Слайд 3

Structure of National Pharmacovigilance Research Center

Слайд 4

PHARMACOVIGILANCE SERVICES

Слайд 5

More than 30 companies – drug manufacturers
60% - Russian manufacturers
40% -

representatives of foreign companies

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Experienced pharmacovigilance specialists, clinical pharmacologists, Expert Advisory Body;
Responding to the Good

Pharmacovigilance Practice requirements of the EEU Pharmacovigilance System;
Economic benefits for marketing authorization holders in pharmacovigilance system organization on a “turn-key” basis;
Experience with more than 450 drugs.

>20

>450

Drugs in work

> 150

PBRERs written

Results of 2017-2018

>30

Clinical pharmacologists

Experts

Advantages of Pharmacovigilance
National Scientific Center

Scientific works

>3000

Adverse Drug Reactions analyzed

>15

International meetings

Слайд 7

Grant from the Federal State Budgetary Institution National Medical Center for

Pharmacovigilance Research

Results of 2017-2018

Poster on anaphylactic shock prevention for medical organizations

Participation of the Innovation Center ”Skolkovo” projects

Слайд 8

Слайд 9

Webinars

Слайд 10

Literature Monitoring Program

Слайд 11

QPPV Survey Data in the Russian Federation
What hinders the pharmacovigilance system

development in your enterprise?

Assess your level of expertise in pharmacovigilance
on a 10-point scale (1 is the smallest, 10 is the highest)

What factors serve as barriers to the pharmacovigilance system organization in your enterprise?

Conclusions:
The main problems of pharmacovigilance system:
Lack of qualified personnel;
Low level of special knowledge and understanding of what is required from marketing authorization holders.

Слайд 12

Unique software product processing data on undesirable reactions

Слайд 13

Examples of unloading from automated security data processing
WHO, Rawlins&Thompson, Will&Brown, DoTS,

Cramer classifications

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Functions of Expert Advisory Body
Examination of Serious Adverse Reactions
Issuance of independent

peer review findings
Coordination and development of recommendations for pharmacotherapy
Proposals on pharmacovigilance to regulatory authorities
Management of research in the field of pharmacovigilance

Слайд 15

Our possible points of interactions
Getting a membership
Development of pharmacovigilance initiatives in

the Russian Federation

Representation of interests in the Russian region

Access to Drug Safety Databases

Pharmacovigilance. Services, science, education. The main legal acts in PV

Содержание

Good Pharmacovigilance Practice (GVP) of the Eurasian Economic Union, approved by

Structure of National Pharmacovigilance Research Center

PHARMACOVIGILANCE SERVICES

More than 30 companies – drug manufacturers60% - Russian manufacturers40% -

Experienced pharmacovigilance specialists, clinical pharmacologists, Expert Advisory Body;Responding to the Good

Grant from the Federal State Budgetary Institution National Medical Center for

Webinars

Literature Monitoring Program

QPPV Survey Data in the Russian FederationWhat hinders the pharmacovigilance system

Unique software product processing data on undesirable reactions

Examples of unloading from automated security data processingWHO, Rawlins&Thompson, Will&Brown, DoTS,

Functions of Expert Advisory BodyExamination of Serious Adverse ReactionsIssuance of independent

Our possible points of interactionsGetting a membershipDevelopment of pharmacovigilance initiatives in

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