programma fmo 2016 220Х182 eng · 5 pharmacovigilance and state control of clinical trials...

XVIII ANNUAL RUSSIAN CONFERENCE XVIII ANNUAL RUSSIAN CONFERENCE «STATE REGULATION IN THE AREA OF DRUGS «STATE REGULATION IN THE AREA OF DRUGS AND MEDICAL DEVICES CIRCULATION» AND MEDICAL DEVICES CIRCULATION»

XVIII ANNUAL RUSSIAN CONFERENCE «STATE REGULATION IN THE AREA OF DRUGS AND MEDICAL DEVICES CIRCULATION»

2–3November

2016Moscow

Congress-Centre

PROGRAMPROGRAMPROGRAM

2016

2

S H O R T P R O G R A M

Schedule of events November 02

Congress Hall

9.00–12.00 Plenary session

Congress Hall 1

13.00–18.00 Break-out sessionPharmacovigilance and state control of clinical trials conducted in the Russian Federation and Eurasian Economic Union (EAEU)

Congress Hall 2

13.00–15.30 Break-out sessionGlobal trends in the development of drugs circulation regulation

15.45–18.30 Round table Regulation of biomedical cell products circulation

Congress Hall 3

13.00–15.45 Break-out sessionModern regulatory requirements to control and circulation of narcotic drugs and psychotropic substances and their precur-sors, narcotic plants cultivation in the Russian Federation The structure and management of palliative care in the Russian Federation

16.00–18.30 Break-out sessionCurrent issues of control and supervision of drugs circulation

“Amphitheater” hall

13.00–18.30 Break-out sessionDrugs quality control in the Russian Federation and EAEU. Modern challenges and relevant solutions

2016

3

Schedule of Events November 03

Congress Hall 1

09.30–12.00 Break-out sessionGMP standards as a key element of drugs quality control

13.00–17.30 Round tableImplementation of the medical products traceability system in the Russian Federation

Congress Hall 2

09.30–12.00 Break-out sessionMedical devices registration taking into account new regulations of the Eurasian Economic Union

13.00–15.45 Break-out sessionSupervision of medical devices circulation

16.00–18.00 Break-out sessionCurrent issues of medical devices circulation

Congress Hall 3

09.30–12.00 Break-out sessionProvision of drugs for medical purposes. Planning. Efficient procurement. Stock management

13.00–16.00 Round table Technological aspects of pharmaceutical manufacture affecting drugs quality. Quality risks management

“Amphitheater” hall

09.30–15.00 Break-out sessionDrugs examination and registration in the Russian Federation. Drugs circulation in EAEU

15.15–17.30 Round table Pharmaceutical professionals. Modern demands and relevant solutions

C O N F E R E N C E P R O G R A M

4

November 02

November 02

9.00–12.00

Congress hall

Plenary session

with simultaneous

English-Russian

translation

– Conference opening– Regulatory innovations in drugs circulation (I.N. Kagramanyan — First Deputy Minister of Health of the

Russian Federation)– New aspects in the regulation of medical products circulation (M.A. Murashko — Head of the Federal

Service for Surveillance in Healthcare)– State policy in the pharmaceutical industry and medicine (S.A. Tsyb — Deputy Minister of Industry and

Trade of the Russian Federation)– Circulation of drugs and medical products in the Eurasian Economic Union: single market, single regula-

tion (V.N. Koreshkov — Member of the Board (Minister) of Technical Regulation of the Eurasian Eco-nomic Commission)

– Update on the Medicrime convention and serialization (S. Keitel — Director of the European Directorate for the Quality of Medicines and Healthcare (EDQM) of the European Council)

– New medical technologies in clinical practices — from creation to implementation: problems and solu-tions (E.V. Shlyakhto — Director General of the North-Western Federal Medical Research Centre named after V.A. Almazov)

5

Pharmacovigilance and state control of clinical trials conducted in the Russian Federation and EAEU Co-chairs: S.V. Glagolev — Deputy Head of the Division — Head of the Department of Pharmacovigilance Or-ganisation at the Division of the State Quality Control of Medical Products, Roszdravnadzor, M.E. Vrubel — Deputy Head of the Clinical Trials Department at the Division of the State Quality Control of Medical Prod-ucts, Roszdravnadzor– Standard terms and pharmacovigilance, IDMP project (S. Keitel — Director of the European Directorate

for the Quality of Medicines and Healthcare)– Pharmacovigilance. New regulatory provisions (S.V. Glagolev — Deputy Head of the Division — Head of

the Department of Pharmacovigilance Organisation at the Division of the State Quality Control of Medical Products, Roszdravnadzor)

– News on pharmacovigilance regulation in EAEU (S.B. Setkina — Chief Specialist of the Republican Clini-cal and Pharmacological Laboratory, Centre for Examinations and Trials in Healthcare, Republic of Belarus)

– Good pharmacovigilance practices. Recommendations for biotherapeutic products (E.Е. Kunina — repre-sentative of the expert group for pharmacovigilance at AIPM, head of pharmacovigilance unit in Novartis Pharma)

– Organisation of the pharmacovigilance system for the marketing authorisation holder (A. Ryakhin — a member of the task group for pharmacovigilance at the Association of International Pharmaceutical Manufacturers)

– New regulatory requirements to organisation and conduct of clinical trials in the European Union. Clini-cal data transparency (I. Reischl — Head Division for Clinical Trials, Austrian Agency for Health and Food Safety (AGES), Austrian Medicines and Medical Devices Agency)

– General requirements to clinical trials of drugs in Russia and EAEU (D.V. Goryachev — Head of the Drugs Examination Directorate, Central Examination Committee No.3, Ministry of Health of Russia)

– Supervision of clinical trials of drugs. Modern trends (M.E. Vrubel — Deputy Head of the Clinical Trials Department at the Division of the State Quality Control of Medical Products, Roszdravnadzor)

– Requirements to clinical trials in EAEU (I.N. Efremova — Head of the Republican Clinical and Pharmaco-logical Laboratory, Centre for Examinations and Trials in Healthcare, Republic of Belarus)

– Current issues of clinical trials enrolling the minor (I. Figurina — Clinical Trials Committee, Association of International Pharmaceutical Manufacturers)

– Questions. Discussion

November 02

13.00–18.00

Congress Hall 1

Break-out session

with simultaneous

English-Russian

translation


6

November 02

13.00–15.30

Congress hall 2

Break-out session

with simultaneous

English-Russian

translation

Global trends in the development of drugs circulation regulationCo-chairs: K.Y. Belanov — Deputy Head of the Division — Head of the International Cooperation Depart-ment at the Division of the State Quality Control of Medical Products, Roszdravnadzor, V.G. Shipkov — Ex-ecutive Director of the Association of International Pharmaceutical Manufacturers– Participation of the Russian Federation in the global regulatory projects and initiatives as exemplified

by IGDRP, ICМRA, IMDRF (K.Y. Belanov — Deputy Head of the Division — Head of the International Co-operation Department at the Division of the State Quality Control of Medical Products, Roszdravnadzor)

– ICH reform — opportunities & challenges. Global harmonization of the Technical Requirements for reg-istration of medicines (P. Tellner — Director, Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations (EFPIA))

– Contemporary regulatory trends. Good regulatory practices of registration and products assessment — WHO recommendations (D. Decina — Regulatory Networks and Harmonization, Regulatory Systems Strengthening, World Health Organisation)

– FDA’s programs for early access to innovative drugs for patients with life-threatening diseases. Challeng-es and possibilities (R. Nosal — Vice President and head of Global Chemistry, Manufacturing & Controls, “GCMC”, Pfizer)

– Medicinal products accelerated evaluation program PRIME (K. Ramanathan — Chief Scientific Officer, Novartis Group)


2016

7

Modern regulatory requirements to control and circulation of narcotic drugs and psychotropic substances and their precursors, narcotic plants cultivation in the Russian Federation The structure and management of palliative care in the Russian Federation

Chair: I.V. Krupnova — Head of the Division of Licensing and Enforcement of Compliance with Mandatory Requirements of Roszdravnadzor– Legal regulation of circulation of narcotic drugs and psychotropic substances and their precursors, nar-

cotic plants cultivation in the Russian Federation; harmonisation of the regulations of the Russian Fed-eration with the established international principles and norms in the sphere of countermeasures against illegal circulation of narcotic drugs and their precursors (N.M. Nikolaeva — Head of the Department for Regulation of the Pharmaceutical Activities, Circulation of Narcotic Drugs and Psychotropic Substances at the Department for State Regulation of Drugs Provision and Circulation of the Ministry of Public Health of Russia)

– Modern methods of control and supervision of circulation of narcotic drugs and psychotropic substances and their precursors (I.A. Guskova — Deputy Head of the Division of Licensing and Enforcement of Com-pliance with Mandatory Requirements of Roszdravnadzor)

– Peculiarities of licensing of activities related to circulation of narcotic drugs and psychotropic substanc-es and their precursors, narcotic plants cultivation (E.E. Maydykova — Head of Bureau for Licensing of Medical and Pharmaceutical Activities, Ministry of Health of Moscow Region)

– The structure and management of palliative care in the Russian Federation. Problems and solutions. Study of best practices and modern approaches in provision of oncology patients with narcotic drugs for anaesthesia (D.V. Nevzorova — Head Physician, First Moscow Hospice, Moscow Department of Health, Chief Specialist in palliative care of the Ministry of Health of the Russian Federation)

– Improvement in availability of narcotic and psychotropic drugs to patients for anaesthesia, also with the help of import-substitution approaches. Recommendations for setting the design norms for need in narcotic and psychotropic drugs for medical use (L.V. Shershakova — advisor of the Director of Moscow Endocrine Plant)


November 02

13.00–15.45

Congress hall 3

Break-out session


8

November 02

13.00–18.30

“Amphitheater”

hall

Break-out session

with si multaneous

English-Russian

translation

Drugs quality control in the Russian Federation and EAEU. Modern challenges and relevant solutions Co-chairs: V.V. Kosenko — Head of the Division for Organisation of State Quality Control of Medical Prod-ucts of Roszdravnadzor; S. Keitel — Director of the European Directorate for the Quality of Medicines and Healthcare (EDQM)– Drugs quality control in the Russian Federation. Key results, development trends. (V.V. Kosenko — Head of

the Division for Organisation of State Quality Control of Medical Products of Roszdravnadzor)– Drugs quality examination within the scope of the state quality control. Current issues. (E.A. Ryzhkova —

Deputy Director General of the Information and Methodological Centre for Examination, Recording and Analysis of Medical Drugs Circulation of Roszdravnadzor)

– Development of express analysis methods for state control of drugs circulation (R.R. Galeev — Deputy Head of the Department for Quality Control NDT of Drugs, Information and Methodological Centre for Ex-amination, Recording and Analysis of Medical Drugs Circulation of Roszdravnadzor)

– EAEU Pharmacopoeia: technical support and methods of procedure of the Pharmacopoeia Committee (M.V. Zadvornova — a consultant in the Department for Coordination of Standardisation and Metrology of the EAEC Bureau for Technical Support and Accreditation)

– USP Strategy in the Context of Globalization (R. Piervincenzi — Chief Executive Officer of USP)– New trends in the development and updating of monographs and methods of pharmacopoeial analysis

(С. Milne — Scientific Officer, Department of Biological Standardisation, OMCL Networks and HealthCare (DBO), EDQM)

– Practical aspects of vaccines and biologicals batch release in the European market (С. Milne — Scientific Officer, Department of Biological Standardisation, OMCL Networks and HealthCare (DBO), EDQM)

– New approaches to comparison of quality of pharmaceuticals containing one and the same active sub-stance manufactured by different companies (A.I. Revelskiy — Head of the Chromato-Mass-Spectrometry Laboratory at the Analytical Chemistry Chair, Chemistry Department of Lomonosov State University)


2016

9

Regulation of biomedical cell products circulationModerators: A.V. Vasiliev — Director of the Institute of Development named after N.K. Koltsov, RAS, V.V. Kosenko — Head of the Division for Organisation of State Quality Control of Medical Products of Ro-szdravnadzor– Ensuring Quality of Cell- and Tissue-based Products (F. Atouf — Director, Science and Standards, Biolog-

ics, USP)– Regulation of cell therapy products circulation in EU. Peculiarities of clinical trials of cell therapy prod-

ucts (I. Reischl — Head Division for Clinical Trials, Austrian Agency for Health and Food Safety (AGES), Austrian Medicines and Medical Devices Agency)

– Principles and peculiarities of biomedical cell products circulation (A.V. Vasiliev — Director of the Insti-tute of Development named after N.K. Koltsov, RAS)

– Circulation of autologous biomedical cell products (A.V. Melerzanov — Dean at the Biological and Medi-cal Physics Department, Moscow Institute for Physics and Technology (state university)

– Circulation of biomedical cell products in cardiology (F.Yu. Kopylov — Director of Personified Medicine Clinics, I.M. Sechenov First Moscow State Medical Medical University)

– Environmental impact over biomedical cell products stability (A.A. Temnov — Head of the Scientific Laboratory for Cell and Physical-and-Chemical Technologies, N.V. Sklifosovskiy Emergency Aid Scientific and Research Institute)

– International recommendations for research and clinical translation of cell products (Y.V. Sukhanov — aide to A.I. Grigoriev, Vice-President of the Russian Academy of Sciences)

– Peculiarities of pre-clinical and clinical trials of biomedical cell products (E.V. Parfenova — Head of the Post-genomic Technologies Lab in Medicine, Department of Fundamental Medicine, Lomonosov Moscow State University, P.I. Makarevich — senior research assistant, Department of Fundamental Medicine, Lo-monosov Moscow State University)

– Principles for biomedical cell products examination (V.A. Merkulov — Deputy Director General at the Scientific Centre for Medical Products Ex amination, Ministry of Health of Russia)

– Experience of establishing a modern biomedical cell products facility (O.V. Grigorieva — Deputy Director at Sellretta Pharm LLC, V.E. Bokovanov — aide to Director General of Sellretta Pharm LLC)


November 02

15.45–18.30

Congress hall 2

Round table

with simultaneous

English-Russian

translation


10

November 02

16.00–18.30

Congress hall 3

Break-out session

Current issues of control and supervision of drugs circulationChair: I.V. Krupnova — Head of the Division of Licensing and Enforcement of Compliance with Mandatory Requirements of Roszdravnadzor– Innovations in supervision of wholesale and retailing of drugs; current issues and challenges, solutions.

Rules of good distribution practices; rules of good drug storage and transportation practices; rules of good pharmacy practices. Changes in laws on licensing of pharmaceutical activities. (I.V. Krupnova — Head of the Division of Licensing and Enforcement of Compliance with Mandatory Requirements of Ro-szdravnadzor)

– State regulation of prices for drugs included into the vital and essential drugs list. Efficiency of control and supervision of prices for drugs included into the vital and essential drugs list (V.S. Fisenko — Head of the Division for Control of State Programs Implementation on Health Care of Roszdravnadzor)

– Good pharmaceutical practices in the Eurasian Economic Union (D.A. Rozhdestvenskiy, A.M. Kravchuk. — Department of Coordination of Formation of Common Drugs and Medical Products Markets at the Division for Technical Regulation and Accreditation of the Eurasian Economic Commission)

– Delivery. Internet. Supervision (N.V. Ignatieva — Executive Director of the Russian Association of Net-works of Pharmacies)

– Introduction of the standard for supply chain safety management. Risk-oriented approach application for implementation of good distribution practices (Zh.P. Titova — Quality Assurance Director at Santens Logistic Group)

– GDP introduction. Where to start? Current issues related to the quality assurance executive (V.V. Galyamova — Executive Director at Katren)


2016

11

November 03

GMP standards as a key element of drugs quality controlCo-chairs: V.V. Kosenko — Head of the Division for Organisation of State Quality Control of Medical Prod-ucts of Roszdravnadzor, O.N. Kolotilova — Director of the Department for Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of Russia– Current provisions of Decree of the Government of the Russian Federation No. 686 dated 06.07.2012 (as

amended on 15.04.2013) On Approval of the Regulation on Drugs Manufacture Licensing. Harmonisa-tion of the rules of good manufacturing practices (Order No.916 of the Ministry of Industry and Trade of Russia) with the current EU GMP rules (E.V. Denisova — Head of the Division for Drugs Manufacture Licensing, Department for Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of Russia)

– Experience of foreign manufacturers examination for compliance with GMP standards. Key non-compli-ances and recommendations by the inspector (V.N. Shestakov — Director of State Institute of Drugs and Good Practices)

– Modern approaches to GMP inspections by FDA (C. McIff — U.S. Food and Drug Administration, U.S. Mis-sion to the European Union)

– The system of inspection of drug manufacturers for compliance with GMP in Russia. PIC/S compliance as-sessment (A.P. Meshkovskiy — Associate Professor at the Industrial Pharmaceutics Chair, I.M. Sechenov First Moscow State Medical University, WHO expert)

– Analysis of results of the first GMP inspections of foreign manufacturers: industry’s perspective. Results and corrections of mistakes by the industry and inspector (M. Khazanchuk — Chair of the Investment Policy and Supply Chain, AIPM)

– Classification of non-compliances revealed during an inspection and the algorithm of categorisation decision-making. Global approaches (T. Graberg — European Federation of Pharmaceutical Industries and Associations (EFPIA))


November 03

09.30–12.00

Congress hall 1

Break–out session

with simultaneous

English-Russian

translation


12

November 03

09.30–12.00

Congress hall 2

Break–out session

Medical devices registration taking into account new regulations of the Eurasian Economic UnionCo-chairs: E.M. Astapenko — Head of the Division for Organisation of State Control and Registration of Medical Devices of Roszdravnadzor, I.I. Monogarova — Head of the Legal and Regulatory Department for Medical Devices Circulation, Ministry of Health of the Russian Federation, I.V. Ivanov — Director General of the Centre for Monitoring and Clinical and Economic Evaluation of Roszdravnadzor– Regulation of the common medical devices market in EAEU (D.A. Schekin — Deputy Head of the Depart-

ment of Coordination of Drugs and Medical Products Circulation at the Bureau for Technical Regulation and Accreditation of the Eurasian Economic Commission)

– General requirements to the safety and efficiency of medical devices as the basis for medical products circulation in the Eurasian Economic Union (V.S. Antonov — aide to Director General of the Centre for Monitoring and Clinical and Economic Evaluation of Roszdravnadzor)

– Medical devices classification in the Eurasian Economic Union (A.V. Preobrazhenskiy — Deputy Head of the Medical Devices Registration Department at the Division of the State Control and Registration of Medical Products, Roszdravnadzor)

– Peculiarities of clinical trials for registration in the Eurasian Economic Union (A.A. Valeeva — Depu-ty Head of the Division for Organisation of State Control and Registration of Medical Devices of Rosz-dravnadzor)

– Release for circulation in the Eurasian Economic Union (B.Zh. Abdimanova — Head of the Bureau for Specialised Examination of Medical Products, National Centre for Examination of Drugs, Medical Products and Medical Devices at the Ministry of Health and Social Development of the Republic of Kazakhstan)

– Monitoring of safety, quality and efficiency of medical devices in the Eurasian Economic Union (T.V. Ivanova — acting Head of the Department for Medical Devices Monitoring at the Russian Research and Testing Institute of Medical Engineering, Roszdravnadzor)

– Introduction of the quality management system in the Eurasian Economic Union. Inspections of medical devices manufacturing sites (E.I. Akhtyamov — Deputy Head of the Division of Licensing and Enforce-ment of Compliance with Mandatory Requirements of Roszdravnadzor)


2016

13

Provision of drugs for medical purposes. Planning. Efficient procurement. Stock managementCo-chairs: D.V. Parkhomenko — Deputy Head of Roszdravnadzor, E.A. Maksimkina — Director of the De-partment for Drugs Provision and Regulation of Medical Devices Circulation of the Ministry of Health of Russia– Preferential provision of drugs. Legislative changes, prospects (O.A. Konstantinova — Deputy Director

of the Department for Drugs Provision and Regulation of Medical Devices Circulation of the Ministry of Health of Russia)

– Creation of the information and analytical system for drugs procurement monitoring for state and mu-nicipal needs (IAS) (E.L. Boyko — Director of the IT and Communications Department of the Ministry of Health of Russia, D.V. Romanov — Deputy Director of the IT and Communications Department of the Ministry of Health of Russia, V.S. Fisenko — Head of the Division for Control of State Programs Implemen-tation on Health Care of Roszdravnadzor)

– Provision of drugs to coronary stenting patients as a means of prognosis improvement: clinical and economic analysis (L.V. Shukil — Deputy Minister of Health in Omsk Region, Head of the Department of Pharmaceutical Activities and Drugs Production of the Ministry of Health of Omsk Region)

– School for patients as an efficient way to improve compliance (Yu.A. Zhulev — President of the Russian Haemophilia Society)

– Theory and practice of drugs provision: are they related? (R.I. Yagudina — Head of the Chair for Organisa-tion of Drugs Provision and Pharmacoeconomics of I.M. Sechenov First Moscow State Medical University)

– Key trends in vital and essential drugs sector development at the pharmaceutical market of Russia (M.N. Denisova — General Manager of IMS Health analytical company)


November 03

09.30–12.00

Congress hall 3

Break–out session


14

November 03

09.30–15.00

“Amphitheater”

hall

Break–out session

Drugs examination and registration in the Russian Federation. Drugs circulation in EAEU.Co-chairs: A.G. Tsyndymeev — Director of the Department for State Regulation of Drugs Circulation of the Ministry of Health of Russia, A.A. Shakkaliev — Director of the Bureau for Technical Regulation and Ac-creditation of the Eurasian Economic Commission, Yu.V. Olifer — Director General at the Scientific Centre for Medical Products Examination, Ministry of Health of Russia– EAEU Pharmacopeia and State Pharmacopoeia of the Russian Federation: current state, development and

cooperation perspectives (E.I. Sakanyan — Director of the Centre of Pharmacopoeia and International Cooperation of the Scientific Centre for Assessment of Medical Products, Ministry of Health of the Russian Federation, Deputy Chairman of the Council of the Ministry of Health of the Russian Federation for State Pharmacopoeia, Doctor of Pharmacy)

– General principles and requirements of the Russian laws to registration dossier in the form of a technical document (A.V. Simonova — Deputy Head of the Control and Organisation Directorate, Scientific Centre for Assessment of Medical Products, Ministry of Health of Russia)

– Drugs interchangeability. Legislative requirements of the Russian Federation. Expert approaches (E.N. Rychikhina — Head of the Control and Organisation Directorate, Scientific Centre for Assessment of Medical Products, Ministry of Health of Russia)

– Current requirements to drug formulation quality assessment and test methods (L.I. Mitkina — Head of the Drugs Examination Directorate, Central Examination Committee No.2, Scientific Centre for Assess-ment of Medical Products, Ministry of Health of Russia)

– Expert examination of study results of pharmaceutical safety of drugs (G.N. Engalycheva — Deputy Head of the Drugs Examination Directorate, Central Examination Committee No.4, Scientific Centre for Assess-ment of Medical Products, Ministry of Health of Russia)

– Drugs registration in EAEU: regulation and procedure (A.M. Kravchuk — advisor at the EAEC Bureau for Technical Support and Accreditation)

– Bringing the dossier in line with EAEU regulations as the main procedure for drugs circulating at local markets (D.A. Rozhdestvenskiy — Deputy Head of the Department of Coordination of Formation of Com-mon Drugs and Medical Products Markets at the Bureau for Technical Regulation and Accreditation of the Eurasian Economic Commission)


2016

15

Implementation of the medical products traceability system in the Russian FederationModerators: M.A. Murashko — Head of the Federal Service for Surveillance in Healthcare, E.L. Boyko — Di-rector of the IT and Communications Department of the Ministry of Health of Russia, D.Yu. Grigorenko — Deputy Head of the Federal Tax Service– Products labelling system introduction. Experience of RF FTS (D.Yu. Grigorenko — Deputy Head of the

Federal tax Service)– Drug labelling system in the Russian Federation (M.A. Murashko — Head of the Federal Service for Sur-

veillance in Healthcare)– Approaches to implementation of the project to build a traceability system (D.Yu. Bagley,

D.S. Scorcelletti — CentrInform)– Experience of Biocad in introduction of the drug labelling system (P.I. Palnikov — Head of the IT Support

Department of BIOCAD)– Practical aspects of introduction of the production serialization system (M.J. Schoen — Senior Manager,

Global Anticounterfeiting, Boehringer Ingelheim)– Drugs traceability system. Distributor’s prospective. New possibilities and risks. (V.V. Galyamova — Ex-

ecutive Director at Katren)– The model for organisation of the European Drug Circulation Monitoring System. Lessons learnt from the

current pilot projects (P. Mardov–Egwang — Senior Regulatory Intelligence Manager, Novo Nordisk A/S, Denmark)

– Provision of drug products traceability equipment and software by manufacturers– Questions. Discussion

November 03

13.00–17.30

Congress hall 1

Round table

with simultaneous

English-Russian

translation


16

November 03

13.00–15.45

Congress hall 2

Break–out session

Supervision of medical devices circulationCo-chairs: E.M. Astapenko — Head of the Division for Organisation of State Control and Registration of Medical Devices of Roszdravnadzor, M.A. Migeeva — Deputy Head of the Division for Organisation of State Control and Registration of Medical Devices of Roszdravnadzor– Supervision of medical devices circulation in the Russian Federation (M.A. Migeeva — Deputy Head of

the Division for Organisation of State Control and Registration of Medical Devices of Roszdravnadzor)– Medical devices safety monitoring as a resource for control over medical devices circulation in the Rus-

sian Federation (A.A. Valeeva — Deputy Head of the Division for Organisation of State Control and Reg-istration of Medical Devices of Roszdravnadzor)

– Violations revealed during examination of quality, efficiency and safety within the scope of state control of medical devices circulation (L.Yu. Nikiforova — Head of Examination Department at the Russian Re-search and Testing Institute of Medical Engineering, Roszdravnadzor)

– Responsibility for violations during medical devices circulation. Measures taken by persons in charge of medical devices circulation in order to eliminate violations revealed during state control of medical devices circulation (A.A. Dorofeev — Head of the Department for Organisation and Conduct of State Control of Medical Devices Circulation at the Division for Organisation of State Control and Registration of Medical Devices of Roszdravnadzor)

– Procedure of amendments into the registration documents of a medical devices following state control of medical devices circulation (O.V. Zhivlova — Head of the Department of Registration Documents Amendments at the Division for Organisation of State Control and Registration of Medical Devices of Roszdravnadzor)

– Quality management system as a tool for medical devices quality management at all stages of circulation (N.S. Ankhimova — Localisation Group Head at GE Healthcare)

– Medical devices circulation regulation in Serbia (Vesna Ševaljević — Medicines and Medical Devices Agency of Serbia)


2016

17

Technological aspects of pharmaceutical manufacture affecting drugs quality. Quality risks managementModerators: A.A. Trapkova — Deputy Head of the Division for Organisation of State Quality Control of Medical Products of Roszdravnadzor, V.A. Dmitriev — Director General of the Association of Russian Phar-maceutical Manufacturers– Quality risks management as exemplified by immunobiological products manufacture (L.V. Rozhkovskaya —

QA Manager at the Bacterial and Viral Drugs Plant of the Institute of Poliomyelitis and Viral Encephalitis name after M.P. Chumakov)

– Transfer of biologicals manufacturing to the local site — main challenges (J.–J. Kielwasser — Head of Biologics External Manufacturing, Emerging Markets (PTBXE), F. Hoffmann-La Roche Ltd )

– Quality risks management as exemplified by a large pharmaceutical production site (O.V. Maklakova — Quality Assurance Director at Akrikhin)

– Experience of manufacturing localisation in the Russian Federation as exemplified by Sanofi (A.V. Gusev — Contract Manufacturing Specialist, V.S. Egorov — QA Expert, Sanofi Russia)

– Technological and economic peculiarities of localisation of innovative drug production as exemplified by ViiV Healthcare (D. Vinogradov — Production Localisation, ViiV Healthcare)

– Experience of technologies transfer to Russian facilities (N.V. Menshutina — Director of the Russian-Swiss Training and Scientific Centre for Pharmaceutical and Biological Technologies Transfer)


November 03

13.00–16.00

Congress hall 3

Round table


18

November 03

15.15–17.30

“Amphitheater”

hall

Round table

Pharmaceutical professionals. Modern demands and relevant solutionsModerators: T.V. Semenova — Director of the Department for Medical Education and HR Policy in Health-care at the Ministry of Health of Russia, E.V. Nevolina — Director of the Good Pharmacy Practices Depart-ment at the Good Practices Training Centre of the State Institute for Dugs and Good Practices– Transition of pharmacy staff to the continuous medical and pharmaceutical training system

(T.V. Semenova — Head of the Department for Medical Education and HR Policy in Healthcare at the Ministry of Health of Russia)

– Mission of the Professional Pharmacy Qualification Council (PQC) in pharmacy as regards qualification improvement (A.D. Apazov — GPP President, PQC Chairman at the National Council for Qualification Improvement at the President of the Russian Federation)

– Good pharmacy practices. Professional standards. Practical experience (E.V. Nevolina — Director of the Good Pharmacy Practices Department at the Good Practices Training Centre of the State Institute for Dugs and Good Practices)

– Global experience in public and professional evaluation of training programs in pharmacy (R.I. Yagudina — Chair of Moscow Pharmaceutical Society, a member of GPP and PQC)

– Results of primary accreditation in Pharmacy for 2016. The role of the National Pharmacy Chamber in ac-creditation. Elaboration of assessment tools for accreditation of specialists and independent assessment of pharmacy staff qualifications (I.V. Kosova — Chair Head of at the Peoples` Friendship University of Russia, a member of PQC)

– Federal training standards updating for compliance with the requirements to professional pharmacy stan-dards (I.G. Komissinskaya — Vice President of Kursk State Medical University, a member of PQC)


2016

19

Current issues of medical products circulationCo-chairs: E.M. Astapenko — Head of the Division for Organisation of State Control and Registration of Medical Devices of Roszdravnadzor, I.V. Ivanov — Director General of the Centre for Monitoring and Clinical and Economic Evaluation of Roszdravnadzor– Explanation by officials from Roszdravnadzor and subordinate expert organisations of questions arising

during medical devices circulation, also during medical devices registration, supervision of circulation

November 03

16.00–18.00

Congress hall 2

Break–out session

Please note that the Steering Committee of the conference reserves the right

to make changes into the program and list of spokespersons