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  1. Principles of Pharmacovigilancesystem introduced by a manufacturer of medicinal products.A summary of two-year performance of pharmaceutical GVP system

  2. You can address your questions/comments to speakers viaWhatsApp +7 (967)-374-71-75

  3. Not simple way toGVP Presence of regulatory act... Speaker: Romanov Boris Konstantinovich, M.D., Deputy Director for Science ofFSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

  4. Problems ofGVP introduction • Critical processes: • Pharmacovigilance system master file • - Inspections Speaker: Romanov Boris Konstantinovich, M.D., Deputy Director for Science ofFSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

  5. You can address your questions/comments to speakers viaWhatsApp +7 (967)-374-71-75

  6. EAEU documents including pharmacovigilance issues Speaker: Rozhdestvensky Dmitry Anatolyevich, PhD (Medicine), Technical Regulation and Accreditation Department​Eurasian Economic Commission, e-mail: rozhdestvenskiy@eecommission.org, p/n: +7 (495) 669-2400 (add. 3141)

  7. When risk–benefit analysis is performed? Speaker: Rozhdestvensky Dmitry Anatolyevich, PhD (Medicine), Technical Regulation and Accreditation Department​Eurasian Economic Commission, e-mail: rozhdestvenskiy@eecommission.org, p/n: +7 (495) 669-2400 (add. 3141)

  8. Consequences of risk-benefit analysis Speaker: Rozhdestvensky Dmitry Anatolyevich, PhD (Medicine), Technical Regulation and Accreditation Department​Eurasian Economic Commission, e-mail: rozhdestvenskiy@eecommission.org, p/n: +7 (495) 669-2400 (add. 3141)

  9. Time frames for PSUR Language of submission: Russianfor theexecutive summaryandintegral risk-benefit analysis. Translating of other paragraphs into Russian – upon additional request within 30 days. Internationalbirthdate (IBD) is the date of the first marketing authorization for a medicine in any country in the world, containingcertainactive substance. Speaker: Rozhdestvensky Dmitry Anatolyevich, PhD (Medicine), Technical Regulation and Accreditation Department​Eurasian Economic Commission, e-mail: rozhdestvenskiy@eecommission.org, p/n: +7 (495) 669-2400 (add. 3141)

  10. You can address your questions/comments to speakers viaWhatsApp +7 (967)-374-71-75

  11. Pharmacovigilance system basicelements Speaker: Krasheninnikov Anatoly Evgenievich, PhD, ANO «National Pharmacovigilance Research Center» CEO, RQA and ISoP member

  12. You can address your questions/comments to speakers viaWhatsApp +7 (967)-374-71-75

  13. Planned changes in the EAEU legislative regulation of pharmacovigilance requirements amendments – IV quarterof 2019 Level II documents Regulation of Good Pharmacovigilance Practice of Eurasian Economic Union under development – III quarterof 2020 under consideration GUIDELINES FOR CONDUCTING THE INSPECTIONS OF THE PHARMACOVIGILANCE SYSTEM GUIDELINES FORASSESSMENT OF THE RISK MANAGEMENT PLAN Level III documents GUIDELINES FORASSESSMENT OF THE PERIODIC SAFETY UPDATE REPORT GUIDELINES FOR EVALUATION OF BENEFIT-RISK RATIO under development – II-III quarters of 2020 GUIDELINES FOR SIGNAL DETECTION PROCEDURE under development –IV quarterof 2020 • Speaker: Setkina Svetlana, Republican Unitary Enterprise «Center for examinations and tests in health service»The Ministry of Healthof the Republic of Belarus

  14. Planned changes to the Regulation of Good Pharmacovigilance Practice RMP PSUR PV system master file GVP EAEU Addendum: Submission of information on NIPASS Requirements to PV documentation Additional monitoring PASS Risk minimization measures Addendums: - Educational materials - DHPL template Risk management system Safety communication Signal management Management of ICSR Addendum: Methodological aspects of signal detection Requirements to PV processes and procedures PV inspections PV audits QPPV PV quality system PV critical processes Requirements to PV quality system Definitions • Speaker: Setkina Svetlana, Republican Unitary Enterprise «Center for examinations and tests in health service»The Ministry of Healthof the Republic of Belarus

  15. GVP inspection throughout the life cycle of medicinal products MAH has not previously operated a pharmacovigilance within the EAEU / in the process of establishing a new pharmacovigilance system Risk-based approach Routine inspections For-cause inspection (PV inspection triggers) Available information (from RA) indicates that the MAH has a poor history of compliance PV system requirements GVP inspection GVP inspection GVP inspection Product-specific safety concerns (e.g., complication with possibility to implement RMP, product-specific risk minimisation additional and routine activity) Post-authorisation use Development Authorisation Pre-authorization period Post-authorization period RA can conduct PV inspection in any time of life cycle of medicinal product RA: - publishes annual PV inspection plan - Initiates “for-cause” PV inspection procedure when triggers are identified Not mandatory, BUT RA can conduct PV inspection before marketing authorisation is granted for examining of compliance of MAH PV system (existed or planned) to legislation and GVP requirements • Speaker: Setkina Svetlana, Republican Unitary Enterprise «Center for examinations and tests in health service»The Ministry of Healthof the Republic of Belarus

  16. Level III document for PV inspections GUIDELINES FOR CONDUCTING THE INSPECTIONS OF THE PHARMACOVIGILANCE SYSTEM PN inspection initiation procedure Inspection initiation Determining of the inspection group Inspection announcement Inspection preparation Possibility of forming an inspection team with the involvement of inspectors of two or more RA Optimization / PV inspections plans coordination PV inspection procedure Inspection opening Examining PV processes, documentation, systems Inspection findings Inspection closure PV inspection reporting procedure Procedure for preparing an inspection report PV inspection report requirements Addendums PV system inspection report Review of weaknesses / inconsistencies of MAH PV system detected by PV inspection PV inspection data exchange form Classification of MAH PV system weaknesses / inconsistencies • Speaker: Setkina Svetlana, Republican Unitary Enterprise «Center for examinations and tests in health service»The Ministry of Healthof the Republic of Belarus

  17. You can address your questions/comments to speakers viaWhatsApp +7 (967)-374-71-75

  18. Regulatorydocuments • Code of the Republic of Kazakhstan dated 18 September 2009 «On People's Health and Healthcare System» - Article 85 «Pharmacovigilance and monitoring of the safety, quality and effectiveness of medical devices» • Order of theMinistry of Healthcare and Social Development of theRepublic of KazakhstanNo.392 dated 27 May 2015 «On approvalGxP» Annex 6 (Good Pharmacovigilance Practice - GVP) • Order of theMinistry of Healthcare and Social Development of theRepublic of Kazakhstan No.421 dated 29 May 2015 «Rules for conducting pharmacovigilance of medicines and monitoring side effects of medicines, medical devices and medical equipment» • Order ofMinistry of Healthcare and Social Development of theRepublic of KazakhstanNo.106 dated 27 February 2015 «On approval of the Rules of the prohibition, suspension or withdrawal from circulation of medicines, medical devices and medical equipment» • Order of theHealth Ministerof theRepublic of KazakhstanNo.701 dated 12 November 2009 «On approval of the Rules for the withdrawal of samples of medicines, medical devices and medical equipment for expertise» • Guidelines on good pharmacovigilance practices of Eurasian Economic Union approved by Council’s decision of the Eurasian Economic Commission No.87 dated 03 November 2016; Speaker: Abdrakhmanov Malik Zhanalykovich, PhD (Medicine), coordinatorof the Department of pharmacovigilance, safety monitoring, efficiency and quality of medical devicesof theRepublic of Kazakhstan. Web: ndda.kz, e-mail: m.abdrakhmanov@dari.kz, phone number: +77172 78 98 28

  19. Regulation of circulationof medicines and medical devices in the Republic of Kazakhstan Ministry of Healthcare of the Republic of Kazakhstan National Center for Expertise of medicines and medical devices of theQuality and Safety Committeeof the Ministry of Healthcare Quality and Safety Committeeof the Ministry of Healthcare Local office of the Representative Territorial department Committee17 Speaker: Abdrakhmanov Malik Zhanalykovich, PhD (Medicine), coordinatorof the Department of pharmacovigilance, safety monitoring, efficiency and quality of medical devicesof theRepublic of Kazakhstan. Web: ndda.kz, e-mail: m.abdrakhmanov@dari.kz, phone number: +77172 78 98 28

  20. Interaction system • Information on side effects of drugs • Report serious adverse reactions (death, life threatening, lack of effectiveness, abuse, off-label use, unregistered drugs) within 48 hours. • Conclusions about casuality and benefit-risk profile. • Regulatory actions • Withdrawal of samples • Prohibition of medical use and withdrawal from circulation or suspension of medical use of lot of drugsAmending the instructions for medical use • Appointment of a MAH inspection • Suspension of action/Recall of the marketing authorisation Speaker: Abdrakhmanov Malik Zhanalykovich, PhD (Medicine), coordinatorof the Department of pharmacovigilance, safety monitoring, efficiency and quality of medical devicesof theRepublic of Kazakhstan. Web: ndda.kz, e-mail: m.abdrakhmanov@dari.kz, phone number: +77172 78 98 28

  21. Pharmacovigilance Pharmacovigilance system: 3 6 4 2 5 1 Monitoring drug safety data from other sources Collection and verification of reports of ADRs Annual assessment of benefit-risk profile of drugs Regulatory actions Analysis, assessment and expertise of drug safety data from MAH Signal evaluation based on a database for monitoring side effects of drugs Speaker: Abdrakhmanov Malik Zhanalykovich, PhD (Medicine), coordinatorof the Department of pharmacovigilance, safety monitoring, efficiency and quality of medical devicesof theRepublic of Kazakhstan. Web: ndda.kz, e-mail: m.abdrakhmanov@dari.kz, phone number: +77172 78 98 28

  22. Current state Speaker: Abdrakhmanov Malik Zhanalykovich, PhD (Medicine), coordinatorof the Department of pharmacovigilance, safety monitoring, efficiency and quality of medical devicesof theRepublic of Kazakhstan. Web: ndda.kz, e-mail: m.abdrakhmanov@dari.kz, phone number: +77172 78 98 28

  23. Prospects • Re-organization • Creation of new units • Involvement of outside specialists, industry experts • Introduction • New technological solutions • Pharmacoepidemiology • Development • risk-oriented approach • Integration in EAEU Pharmacovigilance system • Preparation of theBachelor Degree Program,PhD (Pharmacovigilance) Speaker: Abdrakhmanov Malik Zhanalykovich, PhD (Medicine), coordinatorof the Department of pharmacovigilance, safety monitoring, efficiency and quality of medical devicesof theRepublic of Kazakhstan. Web: ndda.kz, e-mail: m.abdrakhmanov@dari.kz, phone number: +77172 78 98 28

  24. Speaker: Abdrakhmanov Malik Zhanalykovich, PhD (Medicine), coordinatorof the Department of pharmacovigilance, safety monitoring, efficiency and quality of medical devicesof theRepublic of Kazakhstan. Web: ndda.kz, e-mail: m.abdrakhmanov@dari.kz, phone number: +77172 78 98 28

  25. You can address your questions to speakers viaWhatsApp +7 (967)-374-71-75

  26. How prepared are Kazakhstan drug companies for inspections? • The results of a small anonymous survey of Kazakhstan pharmaceutical manufacturers* showed that: • All manufacturing companies carefully follow the legislation regarding the organization and conduct of pharmacovigilance. • All surveyed companies conducted an internal audit of the pharmacovigilance system. • Only a few have passed inspection by the regulator (successful). • *was surveyed: • large companies with a huge assortment portfolio (3); • medium companies with a small portfolio of widely used products(4); • small companies with a limited range of medicines(3). Speaker: Durmanova Marina, president ofPharmaceutical Support and Development Associationof Republic of Kazakhstan

  27. The main difficulties in organizing the pharmacovigilance system currently experienced by pharmaceutical manufacturers in Republic of Kazakhstan • Among the difficulties local manufacturers called: • The shortage of personnel who have experience in the field of pharmacovigilance; • Combining the QPPV position with other positions (typical for small companies, large and medium-sized enterprises have entire departments); • Low involvement of medical workers and pharmacists; • Low patient awareness of the need to report side effects of drugs. Misunderstanding of the importance of this work; • Lack of loyalty of heads of healthcare organizations, if necessary, to respond to company inquiries when investigating cases of side effects of drugs; • The presence of fears among company leaders that the identification of cases of side effects of drugs may adversely affect the image of the enterprise. Speaker: Durmanova Marina, president ofPharmaceutical Support and Development Associationof Republic of Kazakhstan

  28. Among the positive factors QPPVs noted: • Professionality and involvement of representatives of the expert body; • Conducting pharmacovigilance training cycles as part of pre- and postgraduate training programs involving QPPV from pharmaceutical companies; • Enhanced ability to submit reports through the online resource of an expert organization online, by fax, e-mail or on paper. QPPVs called necessary: • Increasing Primary Health Care's involvement in monitoring drug side effects; • Conducting more extensive training programs for medical and pharmaceutical workers (the latter have been recently involved in the pharmacovigilance system, not all pharmacies have trained personnel); • The need for more active educational work among the population. Speaker: Durmanova Marina, president ofPharmaceutical Support and Development Associationof Republic of Kazakhstan

  29. You can address your questions/comments to speakers viaWhatsApp +7 (967)-374-71-75

  30. Speaker: Krasheninnikov Anatoly Evgenievich, PhD, ANO «National Pharmacovigilance Research Center» CEO, RQA and ISoP member

  31. The form of the audit of the pharmacovigilance system, which was performed in the company Internal employees of Quality Dept/Office Colleaguesfrom the partner company External auditors Internal employees from other departments of the company Can not say Allpossible answers was selected Internal employees of Global Pharmacovigilance Office Speaker: Krasheninnikov Anatoly Evgenievich, PhD, ANO «National Pharmacovigilance Research Center» CEO, RQA and ISoP member

  32. You can address your questions/comments to speakers viaWhatsApp +7 (967)-374-71-75

  33. An Audit is a systematic, disciplined, independent and documented process of evaluating objective facts on the performance of a pharmacovigilance system in a company PLANNED AUDIT LEVEL OPERATIONAL (how?) STRATEGIC (when?) TACTICAL (what?) Speaker: Kirichenko Ivan, «InfamedK» Ltd medical director

  34. PHARMACOVIGILANCE COVERS ALL THE ELEMENTS IN A COMPANY’S ORGANIZATIONAL STRUCTURE Medical Pharmacovigilance PHARMACOVIGILANCE Registration R&D Pharmaceuticals Sales Marketing IT HR Distributors Speaker: Kirichenko Ivan, «InfamedK» Ltd medical director

  35. ROLE OF DISTRIBUTORS:source of information about drugs efficiency, safety and quality MAHPharmacovigilance Distributor Pharmacies End consumer Конечный потребитель Дистрибьютор Аптеки Speaker: Kirichenko Ivan, «InfamedK» Ltd medical director

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  37. Significance of the role of distributors as a participant in thepharmacovigilancesystem(from 1 to 10 points) as estimated by drug manufacturers • Significance of the role of distributors as a participant in the pharmacovigilance system (from 1 to 10 points) as estimated by pharmacies Speaker: Krasheninnikov Anatoly Evgenievich, PhD, ANO «National Pharmacovigilance Research Center» CEO, RQA and ISoP member

  38. Role of QPPV in Company structure Chief Executive Officer Commercial director Medical Director Director-at-large QPPV LQPPV Speaker: Krasheninnikov Anatoly Evgenievich, PhD, ANO «National Pharmacovigilance Research Center» CEO, RQA and ISoP member

  39. You can address your questions to speakers viaWhatsApp +7 (967)-374-71-75