1. Interconnection of good practices: from development to distribution
Romanov Boris Konstantinovich, PhD., Deputy Director for Science of FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Krasheninnikov Anatoly Evgenievich, PhD, ANO «National Pharmacovigilance Research Center» CEO, RQA and ISoP member

2. Good Practice Correlation
Identify drug quality problems
GVP
GMP
GDP
GCP
Monitoring the effectiveness and safety of drugs
Planning, assessment and control of the safety level of the investigated drugs
Additional Clinical trials

3. Pharmacovigilance Pharmakon Vigilare Pharmaco vigilance
Vigilare‘ (vigilance)
Medical institutions
Pharmacy organizations
Population
Drug product manufacturer / MAH
Distributors

4. Principles of pharmacovigilance system organized by Marketing Authorization Holder
Principle of independence;
Principle of continuity;
Principle of the quality;
Principle of involvement of management, staff, contractors;
Principle of completeness of safety information collection;
Principle of assistance;
Principle of social and legal responsibility;
Principle of resource availability;
Principle of scientific evaluation;
Principle of interaction;
Principle of documentation;
Principle of listening;
Principle of improvement and development

5. The main normative legal acts in the field of post-registration pharmacovigilance in Russia (in part of special legislation)
Guidelines on good pharmacovigilance practices of Eurasian Economic Union approved by Council’s decision of the Eurasian Economic Commission No.87 dated 03 November (entered into force );
Federal Law No.61-FZ «On the circulation of medicinal products» dated 12 April 2010 (Article 64 – «Pharmacovigilance», Article 18. «Submission and Review of Applications for State Registration of Medicinal Products for Medical Use»);
Order of Roszdravnadzor No.1071 dated 15 February 2017 «On approval of the pharmacovigilance procedure»;
Order of The Ministry of Health of the Russian Federation No.777 dated 14 November «On the endorsement of the procedure for suspension of use of the medicine for medical application»

6. Classification of risks of Marketing Authorizations Holders
Acceptable risk
Critical risk
Catastrophic risk
Requests from regulatory authorities to confirm the availability of a pharmacovigilance system at the enterprise (Master-file, periodic safety update report, risk management plan, etc.);
Amendments to the instructions for medical use;
Changes to the clinical trial protocol;
Suspension of clinical trials
Administrative liability;
Conducting of additional safety trials and effectiveness of the drug;
Implementation of additional security monitoring measures;
Suspension / withdrawal of drugs from circulation (para.2 art. 65 FZ «On the circulation of medicinal products»)
Cancellation of state marketing authorization of a drug (para. 9 art. 34 FZ «On the circulation of medicinal products»);
Criminal liability (Criminal Code of the Russian Federation, Article 238. Production, Storage, Carriage or Sale of Goods and Products, Fulfillment of Works or Rendering of Services Which Do Not Meet Safety Standards)

7. Basic elements of pharmacovigilance system

8. Sources of adverse drug reactions information

9. Drug product manufacturers
Main difficulties of pharmacovigilance system implementation by subjects of pharmaceutical market circulation
Drug product manufacturers
Medical institutions

10. Main difficulties of pharmacovigilance system implementation by subjects of pharmaceutical market circulation
Pharmacies
Consumers
Distributors

11. The main barriers to organize a pharmacovigilance system
MAH
Medical institutions

12. The main barriers to organize a pharmacovigilance system
Pharmacies
Consumers

13. The main barriers to organize a pharmacovigilance system

14. Pharmacovigilance System Improvement
Improving regulatory legal acts, methodological recommendations 1
Increased activity of participation of drug market circulation entities 2
Improving of information channels 3

15. Mobile App «Lekarstvennaya Bditelnost»
1. Rapid collection of information about adverse reactions, lack of effectiveness
2. Targeted notifications on security issues (doctors, pharmacies, consumers)
3. Management of drug safety observational programs
4. Pharmacovigilance training for doctors, pharmaceutical workers

16. Thank you for your attention!