MINISTRY OF HEALTH OF UKRAINE NATIONAL ACADEMY OF MEDICAL SCIENCES OF UKRAINE PE "THE STATE EXPERT CENTER OF THE MINISTRY OF HEALTH OF UKRAINE" THIRD SCIENTIFIC AND PRACTICAL CONFERENCE IN MEMORY OF OLEKSII VIKTOROV, DOCTOR OF MEDICAL SCIENCES, PROFESSOR SAFETY AND LEGAL SUPPORT OF MEDICINAL PRODUCTS: FROM DEVELOPMENT TO MEDICAL USE October 23-24, 2013 Congress Hall of President Hotel 12, Hospitalna St., Kyiv DEAR COLLEAGUES, We are pleased to invite you to participate in the Third Scientific and Practical Conference on "Safety and Legal Support of Medicinal Products: from Development to Medical Use" in memory of Oleksii Viktorov, Doctor of Medical Sciences, Professor, to be held in Kyiv on October 23-24, 2013. The first and second scientific and practical conferences on “Medicines Safety: from Development to Medical Use” held in Kyiv in 2007 and 2009 specified the issues on safety and use of medicinal products requiring continuous attention, active public discussion and close national and international cooperation. Since then significant changes have taken place in the development and circulation of medicinal products, as well as in regulation of these processes. New regulatory approaches to pharmacovigilance have appeared, new methods for collecting drug safety information have been implemented, approaches to rational pharmacotherapy, preparation and implementation of medical technological documents considering the evidence-based medicine have been improved worldwide and in Ukraine. Discussed at the conference will be a series of organizational and methodological issues pertinent to legal support of medicinal products from their development to medical use, medicines safety and patient safety, status and prospects of improving pharmacovigilance system, formulary system, preclinical, clinical, pharmacoepidemiological and pharmacoeconomic studies, as well as to elucidation of drug safety issues in educational programs etc. KEY TOPICS OF THE THIRD SCIENTIFIC AND PRACTICAL CONFERENCE Legal support of medicinal products throughout their life cycle; Current approaches to pharmacovigilance; Pharmacovigilance system; Risk management system; Medicines safety: peculiarities of use and choice; Patient safety in the focus of pharmacovigilance Formulary system Drug efficacy and safety studies; Pharmacoeconomic studies; Issues of drug safety in educational programs. SCIENTIFIC PROGRAM The program includes plenary lectures, section sessions, round tables, and lectures. A pre-conference workshop on “Applicant’s pharmacovigilance system: legal support and changes in the European legislation” will be held within the conference framework on October 22, 2013. The pre-conference workshop is addressed to applicants, applicant representatives, qualified persons responsible for pharmacovigilance, representatives of regulatory agencies and expert organizations. Issues of organizing and conducting pharmacovigilance by applicants will be reviewed, and legal requirements, as well as approaches to pharmacovigilance realization in Ukraine with due account of changes to the European legislation will be presented at the pre-conference workshop. The program of the Third Scientific and Practical Conference is available at the website of PE “The State Expert Center of the Ministry of Health of Ukraine”: www.dec.gov.ua The Tenth National School of Young Pharmacologists named after O.V. Stefanov, Member NAMS Ukraine, will be held within the framework of the conference on October 23-24, 2013 under the auspices of State Institution “Institute of Pharmacology and Toxicology”, Inter-agency (MoH and NAMS Ukraine) Problem Commission "Pharmacology", the All-Ukrainian Public Organization “Association of Pharmacologists of Ukraine”. The School organizers – the All-Ukrainian Public Organization “Association of Pharmacologists of Ukraine”. LANGUAGE Ukrainian, Russian, English TECHNICAL SUPPORT Available at the conference will be multimedia projector, notebook, overhead, microphone system, simultaneous translation The Third Scientific and Practical Conference on "Safety and Legal Support of Medicinal Products: from Development to Medical Use" in memory of Oleksii Viktorov, Doctor of Medical Sciences, Professor, to be held at the Congress Hall of President Hotel (12, Hospitalna St., Kyiv) on October 23-24, 2013. Registration of the Third Scientific and Practical Conference participants will be held at the Congress Hall of President Hotel at the above address on October 23 from 800 to 900. Registration of participants of pre-conference workshop will be held at the Conference Hall of President Hotel (12, Hospitalna St., Kyiv) on October 22 from 830 to 930. Registration of participants of the Tenth National School of Young Pharmacologists named after O.V. Stefanov, Member NAMS Ukraine, will be held at the lobby of the Conference Hall of Rus Hotel (4, Hospitalna St., Kyiv) on October 23 from 700 to 1000 ORGANIZING COMMITTEE Co-chairs: O.O. Nagorna, R.M. Bogachev, L.V. Konoshevych Deputy Co-chairs: O.V. Matvieieva, I.O. Logvina, V.P. Yaichenia., O.I. Yevko Members of Organizing Committee: O.I. Koniaieva, S.M. Drogovoz, V.D. Lukianchuk, K.A. Posokhova, O.A. Chemet., N.I. Tkachuk, O.Yu. Zaslavskyi, I.V. Kriachok, Yu. B. Navgorodska Secretariat: A.V. Vekhovska, O.P. Vypovska, O.V. Grebinnyk, I.P. Grygorenko, S.Yu. Dorichenko, N.M. Yevtushenko, O.V. Kashuba, N.P. Poniatovska, L.O. Pushkar, Yu.S. Turok, L.O. Fygol, O.L. Khoromska, M.O. Khokhlova, T.I. Bashkatova, V.A. Vasylieva, N.M. Denysiuk, K.V. Pavlenko, V.M. Saienko, S.Ye. Fomenko Conference Program Wednesday, October 23, 2013 8.00 – 9.00 9.00 - 9.30 9.30 - 11.30 11.30 -12.00 12.00 - 13.30 13.30 – 14.30 Congress Hall 14.30 -16.00 16.00 -16.30 16.30 -18.00 18.15 Registration of participants (Congress Hall) Opening ceremony of the conference (Congress Hall) Plenary session (Congress Hall) Coffee break (Congress Hall) Plenary session (Congress Hall) Lunch Hall 1 Hall 2 Conference Conference Center Center Pharmacovigilance tools Legal support of medicinal products Rational drug therapy: role of clinical pharmacist in providing efficacy and safety of medicinal products Safety of medicinal products Potential of health care system in rational pharmacotherapy provision Coffee break Information field as an element of effective and safe treatment Reception Hall 3 Conference Center Development of medicines, pre- and postregistration studies Development of medicines, pre- and postregistration studies Thursday, October 24, 2013 Congres Hall 9.00-10.30 10.30-11.00 11.00-12.30 Active pharmacovigilance Bioequivalence 12.30-13.30 Hall 2 Conference Center Ensuring safety of patients using medicinal products Rational pharmacotherapy: current approaches to therapy from viewpoint of drug efficacy and safety Coffee break Ensuring safety of Rational patients using pharmacotherapy: medicinal products current approaches to therapy from viewpoint of drug efficacy and safety Hall 3 Conference Center Rational pharmacotherapy: risks and their management in treatment process Rational pharmacotherapy: risks and their management in treatment process Lunch 13.30-15.00 Bioequivalence 15.00-15.30 15.30-17.00 Bioequivalence 17.15-18.15 Hall 1 Conference Center Round table: Rational Requirements to pharmacotherapy: pharmacovigilance current approaches in CIS countries: to therapy in view of challenges and drug efficacy and achievements safety Coffee break Round table: Rational Requirements to pharmacotherapy: pharmacovigilance current approaches in CIS countries: to therapy in view of challenges and drug efficacy and achievements safety Adopting the resolution Closing session (Congress Hall) Rational pharmacotherapy: significance of studies for ensuring drug efficacy and safety Rational pharmacotherapy: significance of studies for ensuring drug efficacy and safety 9.00 – 9.30 9.30 – 11.30 October 23, 2013 Congress Hall Hall 1 Opening of the conference. Documentary film on O. P. Viktorov, Doctor of Medical Sciences, Professor Plenary session. Part I PANEL: MOH UKRAINE: R.M. Bogachev PE "The State Expert Center MoH Ukraine": O.O. Nagorna, O.V. Matvieieva International organizations: O. Polishchuk, Sten Olsson O.O. Bogomolets National Medical University, Kyiv, Ukraine: V. Z. Netiazhenko, 1. Safety of medicinal products – a part of the state policy in public health R.M. Bogachev, MoH Ukraine 2. Pharmacovigilance: yesterday, today, forever O. Polishchuk, WHO Regional Office for Europe, Copenhagen, Denmark 3. Harmonization of requirements to safety and efficacy monitoring – experience of Ukraine O.O. Nagorna, PE "The State Expert Center MoH Ukraine", Kyiv, Ukraine 4. Strategies of pharmacovigilance system development in Ukraine O.V. Matvieieva, PE "The State Expert Center MoH Ukraine", Kyiv, Ukraine 11.30 – 12.00 Coffee break 12.00 – 13.30 Plenary session. Part II 1. Do safe medicines exist? V. Z. Netiazhenko, O.O. Bogomolets National Medical University, Kyiv, Ukraine 2. The Economic burden of medicine related patient harm Sten Olsson, Chief, WHO Programme for International Drug Monitoring, Uppsala, Sweden 13.30 – 14.30 Lunch October 23, 2013 Congress Hall Hall 1 14.30 – 16.00 Section 1 Part 1 Pharmacovigilance tools MODERATORS: Ulf Bergman, T.M. Dumenko, O.V. Matvieieva, O.A. Lebega 1. ATC/DDD in pharmacovigilance Ulf Bergman, Karolinska Institute, Stockholm, Sweden 2. Use of ATC/DDD methodology for assessing safety of essential medicines T.M. Dumenko, O.V. Matvieieva, PE "The State Expert Center MoH Ukraine", Kyiv, Ukraine 3. Results of audit of Ukraine's pharmacovigilance system: strengths and weaknesses, directions needed to be developed O.A. Lebega, USAID SIAPS Program, Kyiv, Ukraine 16.00 – 16.30 Coffee break 16.30 – 18.00 Section 5 Rational drug therapy: role of clinical pharmacist in ensuring efficacy and safety of medicinal products MODERATORS: Yu. M. Chernov, G.A. Batishcheva, A.B. Zimenkovskyi, O.Yu. Gorodnycha 1. Organization of clinical pharmacology service in health care setting Yu. M. Chernov, G.A. Batishcheva, N.N. Burdenko Voronezh State Medical Academy, Voronezh, Russian Federation 2. DRP management, drug therapy process, clinical audit – new opportunities of pharmacovigilance A.B. Zimenkovskyi, D. Galytskyi Lviv National Medical University, Lviv, Ukraine 3. New methodological approaches of clinical pharmacist to enhancing safety of drug therapy O.Yu. Gorodnycha, D. Galytskyi Lviv National Medical University, Lviv, Ukraine October 23, 2013 Conference Center Hall 1 14.30 – 16.00 Section 2 Legal support of medicinal products MODERATORS: I. G. Kudriavtseva, A. V. Stepanenko, M. Władysiuk 1. State registration of medicinal products as a stage in ensuring efficacy, safety and quality of medicinal products I. G. Kudriavtseva, PE “The State Expert Center MoH Ukraine", Kyiv, Ukraine 2. Role of medical technological documents in ensuring drug therapy efficacy and safety A. V. Stepanenko, MoH Ukraine, PE "The State Expert Center MoH Ukraine", Kyiv, Ukraine 3. The importance of safety of medicines in НТА report – example from Poland M. Władysiuk, CEESTAHC. HTA Consulting, Krakow, Poland 16.00 – 16.30 Coffee break 16.30 – 18.00 Section 6 Safety of medicinal products MODERATORS: Peter De Veene, L.V. Besh, O.M. Zaliska 1. Approaches to risk management in the application of biosimilars Peter De Veene, EU QPPV, Roche Group 2. Safety of antibiotic therapy in pediatrics L.V. Besh, D. Galytskyi Lviv National Medical University, Lviv, Ukraine 3. Pharmacoeconomic assessment of ADRs based on different pharmacological groups O.M. Zaliska, D. Galytskyi Lviv National Medical University, Lviv, Ukraine October 23, 2013 Conference Center Hall 2 14.30 – 16.00 Section 3 Potential of health care system in ensuring rational pharmacotherapy MODERATORS: O.K. Tolstanov, S.M. Drogovoz, L.S. Savchenkova, O.A. Chemet 1. Using health care system potential in pharmacovigialance O.K. Tolstanov, MoH Ukraine 2. Methodological provision of medicines safety coverage in curricula S.M. Drogovoz, National University of Pharmacy, Kharkiv, Ukraine 3. Significance of regulatory documents and compliance as a main element of pharmacovigilance in Ukraine V.D. Lukianchuk, L.S. Savchenkova, V.V. Rokotianska, SE “Lugansk State Medical University” Lugansk, Ukraine, Regional Division in the Lugansk Oblast, PE "The State Expert Center MoH Ukraine", Lugansk, Ukraine 4. Pharmacovigilance system audit in health care system: need or bureaucracy? O.A. Chemet, Health Care Administration, Uzhgorod Oblast State Administration, Regional Division in the Zakarpatiia Oblast, PE "The State Expert Center MoH Ukraine", Uzhgorod, Ukraine 16.00 – 16.30 Coffee break 16.30 – 18.00 Section 7 Information field as an element of effective and safe treatment MODERATORS: L.Ye. Ziganshyna, N. Olbert-Sinko, Yu. Bagmut, G.V. Guseva 1. Drug promotion – an obstacle on the way towards formation of pharmacovigilance system HAI/WHO manual on Drug Promotion L.Ye. Ziganshyna, Kazan (Volga Region) Federal University, Kazan, Russian Federation 2. Content of information field as an element of ensuring effective and safe treatment N. Olbert-Sinko, Yu. Bagmut, PRP, Kyiv, Ukraine 3. Drug advertising influence on results and safety of treatment G.V. Guseva, PE "The State Expert Center MoH Ukraine", Kyiv, Ukraine October 23, 2013 Conference Center Hall 3 14.30 – 16.00 Section 4 Part 1 Development of medicines, pre- and postregistration studies MODERATORS: O.P. Baula, M.O. Liapunov, I.S. Chekman 1. Safety of medicinal products: focus on active pharmaceutical ingredients O.P. Baula, MoH Ukraine, Kyiv, Ukraine 2. Current requirements to pharmaceutical development – a basis for developing quality, effective and safe medicines M.O. Liapunov, PE "The State Scientific Center for Medicinal Products and Health Care Products", Kharkiv, Ukraine 3. Scientific research in nanopharmacology: state-of-the-art. Nanoproducts safety I.S. Chekman, O.O. Bogomolets National Medical University, Kyiv, Ukraine 16.00 – 16.30 Coffee break 16.30 – 18.00 Section 4 Part 1 Development of medicines, pre- and postregistration studies MODERATORS: L.I. Kovtun, S.K. Zyrianov, I.A. Zupanets, V.A. Usenko 1. Significance of clinical trials in studying efficacy and safety of medicines at the preregistration stage L.I. Kovtun, PE "The State Expert Center MoH Ukraine", Kyiv, Ukraine 2. Postregistration clinical trials as a tool for evaluating safety profile of medicinal products S.K. Zyrianov, M.I. Pyrogov Russian National Research Medical University, MoH Russian Federation, Moscow, Russian Federation 3. Bioequivalence study as a key criterion of assessing safety and efficacy of generic medicinal products I.A. Zupanets, National University of Pharmacy, Kharkiv, Ukraine 4. Placebo and nocebo effects – an issue of evidencing efficacy and safety in clinical trials V.A. Usenko, Dr. Reddy’s Laboratories Ukraine, Kyiv, Ukraine I.A. Zupanets, V.Ye. Dobrova, National University of Pharmacy, Kharkiv, Ukraine October 24, 2013 Congress Hall Hall 1 9.00 – 10.30 Section 7 Active pharmacovigilance MODERATORS: J. Nwokike, S.B. Sietkina, O.I. Koniaieva, 1. International experience on Active PV and the prospects for Ukraine J. Nwokike, USAID SIAPS Program, Washington, USA 2. Implementation of active methods for drug safety monitoring in Republic of Belarus S.B. Sietkina, UE “Center for Examinations and Tests in Health Service”, Minsk, Republic of Belarus 3. Strategy of control of antimicrobial therapy (SCAT) based on Crimean Republican Institution “Clinical Territorial Medical Association “University Clinics” O.I. Koniaieva, O.V. Matvieiev, P.N. Radzyvil, SI “S.I. Georgiievskyi Crimean State Medical University” MoH Ukraine, Simferopol, Ukraine 10.30 – 11.00 Coffee break 11.00 – 12.30 Bioequivalence Seminar MODERATORS: N.O. Zhukova, Dr. Marika Pečená 1. Harmonization of Ukraine's regulations with EC requirements. Amendments to Ukraine's legislation related to bioequivalence. Applied value of BA/BE studies N.O. Zhukova, PE “The State Expert Center MoH Ukraine”, Kyiv, Ukraine 2. Requirements for proving BE in different regulatory agencies Dr. Marika Pečená, Zentiva k.s., Czech Republic 12.30 – 13.30 13.30 – 15.00 Bioequivalence Lunch Seminar MODERATORS: Martin Valchář, Miroslav Ryska 1. Requirements for BE studies in EC for EC and Ukrainian manufacturers Martin Valchář, QUINTA-ANALYTICA, s.r.o., Czech Republic 2. BE studies: milestones of their planning and conducting Miroslav Ryska, QUINTA-ANALYTICA, s.r.o., Czech Republic 15.00 – 15.30 Coffee break 15.30 – 17.00 Bioequivalence Seminar MODERATORS: N.O. Zhukova, I.E. Kuznetsov 1. “Biowaiver” procedure. Situation analysis, positive and negative aspects N.O. Zhukova, PE “The State Expert Center MoH Ukraine”, Kyiv, Ukraine 2. Modified generics: approaches to proving drug efficacy/safety (manufacturers experience) I.E. Kuznetsov, “Clinical and Diagnostic Center “Farmbiotest” Ltd., Rubizhne, Ukraine October 24, 2013 Conference Center Hall 1 9.00 – 10.30 Section 8. Part 1 Ensuring safety of patients using medicinal products MODERATORS: V.G. Serdiuk, N. Kozhan, Ye. Naishtetyk 1. Informed patient as a health care evolution factor V.G. Serdiuk, All-Ukrainian Council for Patients Rights and Safety, Kyiv, Ukraine 2. Action plan on patient safety: infection control and rational antibiotіc therapy N. Kozhan, All-Ukrainian Council for Patients Rights and Safety, Kyiv, Ukraine 3. Patient safety in promoting medical technologies Ye. Naishtetyk, All-Ukrainian Council for Patients Rights and Safety, Kyiv, Ukraine 10.30 – 11.00 Coffee break 11.00 – 12.30 Section 8. Part 2 Ensuring safety of patients using medicinal products MODERATORS: P. Gaievskyi, O. Gryntsova, O. Skoryna, O. Menshutkina 1. Evidence-based principles in ensuring patient safety P. Gaievskyi, Jagiellonian University, “Practical Medicine” Publishers, Krakow, Poland 2. Implementation and monitoring of European norms of ensuring medicines safety O. Gryntsova, EDQM, London, UK 3. Medicines safety and human rights O. Skoryna, All-Ukrainian Council for Patients Rights and Safety, Kyiv, Ukraine 4. European program on health education: competence and safety O. Menshutkina, All-Ukrainian Council for Patients Rights and Safety, Kyiv, Ukraine 12.30 – 13.30 Lunch 13.30 – 15.00 Round table: Part 1 Requirements to pharmacovigilance in CIS countries: challenges and achievements 1. Features of pharmacovigilance in the CIS region I. Lapchinska, GlaxoSmithKline, Kyiv, Ukraine 2. Approximation of regulatory approaches to pharmacovigilance in member- states of the Customs Union V.V. Kosenko, A.A. Trapkova, S.V. Glagoliev, D.O. Chizhova, Administration for Providing State Quality Control for Medical Production, Federal Service on Surveillance in Healthcare (Roszdravnadzor) V.A. Polivanov, Federal State-Financed Enterprise “Information Methodological Center for Healthcare Product Expert Evaluation, Accounting and Circulation Analysis”, Federal Service on Surveillance in Healthcare (Roszdravnadzor) 3. Approaches to pharmacovigilance in Republic of Belarus S.B. Sietkina, UE “Center for Examinations and Tests in Health Service”, Minsk, Republic of Belarus 15.00 – 15.30 Coffee break 15.30 – 17.00 Round table: Part 2 Requirements to pharmacovigilance in CIS countries: challenges and achievements 1. Pharmacovigilance legislation in Kazakhstan R.S. Kuzdenbaieva, National Center of Medicines, Medical Devices and Medical Equipment Expert Evaluation,MoH Republic of Kazakhstan, Almaty, Kazakhstan 2. Pharmacovigilance system in the Moldova Republic in connection with harmonization of national legislation with the European legislation E. Istrati, Medicines Agency of the Republic Moldova, Kyshynev, Moldova 3. Discussion October 24, 2013 Conference Center Hall 2 9.00 – 10.30 Section 9. Part 1 Rational pharmacotherapy: current approaches to therapy from viewpoint of drug efficacy and safety MODERATORS: D.A. Sychev, G.S. Anikin, Yu.M. Syrenko, Yu. O. Gamazin, V.A. Vasylieva 1. Current approaches to combating polypharmacy and their significance for improving safety of pharmacotherapy D.A. Sychev, G.S. Anikin, I.M. Sechenov First Moscow State Medical University , Moscow, Russian Federation 2. Current approaches to rational pharmacotherapy of arterial hypertension Yu.M. Syrenko, PE NSC "M.D. Strazhesko Institute of Cardiology NAMS Ukraine", Kyiv, Ukraine 3. Approaches to assessing benefit/risk of vaccines in immunization programs Yu. O. Gamazin, V.A. Vasylieva, PE "The State Expert Center MoH Ukraine", Kyiv, Ukraine 10.30 – 11.00 Coffee break 11.00 – 12.30 Section 9. Part 2 Rational pharmacotherapy: current approaches to therapy from viewpoint of drug efficacy and safety MODERATORS: B.M. Mankovskyi, Ye.P. Svishchenko, O.V. Davydovych 1. Approaches to interchangeability of medicinal products B.M. Mankovskyi, PE "V.P. Komisarenko Institute of Endocrinology and Metabolism NAMS Ukraine",Kyiv, Ukraine 2. Drug efficacy and safety in current approaches to treatment of essential hypertension Ye.P. Svishchenko, PE NSC "M.D. Strazhesko Institute of Cardiology NAMS Ukraine", Kyiv, Ukraine 3. Factors influencing efficacy and safety of medicines used for treating cardiovascular diseases O.V. Davydovych, P.L. Shupyk National Medical Academy of Postgraduate Education 12.30 – 13.30 Lunch 13.30 – 15.00 Section 9. Part 3 Rational pharmacotherapy: current approaches to therapy from viewpoint of drug efficacy and safety MODERATORS: O. Duzha, U.M. Tilekieieva, D.A. Arapbaieva, S.M. Antoniak, 1. Constituents of effective and safe TB treatment O. Duzha, USAID SIAPS Program, Kyiv, Ukraine 2. Adverse effects of TB medicines to organs of sight U.M. Tilekieieva, D.A. Arapbaieva, I.K. Akhunbaiev Kyrgyz State Medical Academy, Bishkek, Kyrgyz Republic 3. Importance of pharmacovigilance in ARV therapy S.M. Antoniak, PE “L.V. Gromashevskyi Institute of Epidemiology and Infectious Diseases NAMS Ukraine”, Kyiv, Ukraine 15.00 – 15.30 Coffee break 15.30 – 17.00 Section 9. Part 4 Rational pharmacotherapy: current approaches to therapy from viewpoint of drug efficacy and safety MODERATORS: O.O. Yakovleva, V.V. Chopiak, S. Lurye 1. Safety of pharmacotherapy of pulmonary hypertension O.O. Yakovleva, A.A. Klekot, T.N. Masloied, M.I. Pyrogov Vinnytsa National Medical University, Vinnytsa, Ukraine 2. International and domestic approaches to diagnosis, prevention and treatment of drug allergy V.V. Chopiak, D. Galytskyi Lviv National Medical University, Lviv, Ukraine 3. Analysis of prescription of herbal medicines by RxTest method S. Lurye, Medical Data Management, Center of Medical and Pharmaceutical Information, Kyiv, Ukraine October 24, 2013 Conference Center Hall 3 9.00 – 10.30 Section 10. Part 1 Rational pharmacotherapy: risks and their management in treatment process MODERATORS: Ye. Novichkova, Yu.S. Rudyk, A.O. Zhamba, O.O. Yakovleva 1. Risks and their management in healthcare setting Ye. Novichkova, O.O. Bogomolets National Medical University, Kyiv, Ukraine 2. Pharmacogenetic factors influencing drug efficacy and safety Yu.S. Rudyk, PE “L.T. Malaia National Institute of Therapy NAMS Ukraine”, Kharkiv, Ukraine 3. Genetic polymorphism as a predicator of cardiotoxicity of medicines used in bronchial asthma A.O. Zhamba, O.O. Yakovleva, M.I. Pyrogov Vinnytsa National Medical University, Vinnytsa, Ukraine 10.30 – 11.00 Coffee break 11.00 – 12.30 Section 10. Part 2 Rational pharmacotherapy: risks and their management in treatment process MODERATORS: P. Finglas, N. Boyko, O.S. Nemchenko, L.V. Tereshchenko 1. Role of EuroFIR network in ensuring wholesome food for healthy life-style P. Finglas, Institute of Food Research, Norwich, UK 2. Diet and nutrition in Ukraine: quality and safety, analytical approaches, education, legislation, standardization and personification as a method of prevention and treatment of metabolic diseases N. Boyko, Uzhgorod National University, Research and Development Center (R&D Center) 3. Appropriate medical prescription as a basis for providing safe and effective pharmaceutical aid O.S. Nemchenko, L.V. Tereshchenko, National University of Pharmacy, Kharkiv, Ukraine 12.30 – 13.30 Lunch 13.30 – 15.00 Section 11. Part 1 Rational pharmacotherapy: significance of studies for ensuring drug efficacy and safety MODERATORS: K.A. Posokhova, L.V. Yakovleva 1. Current problems of antibacterials use K.A. Posokhova, PE “I.Ya. Gorbachevskyi Ternopil State Medical University”, Ternopil, Ukraine 2. Antibiotics resistance and investigation of antibacterials use in Ukraine and Europe L.V. Yakovleva, National University of Pharmacy, Kharkiv, Ukraine 3. State of antimicrobial resistance monitoring in Ukraine T.G. Glushkevych, Bacteriological laboratory CSES Ministry of Ukraine, Kyiv, Ukraine 15.00 – 15.30 Coffee break 15.30 – 17.00 Section 11. Part 2 Rational pharmacotherapy: significance of studies for ensuring drug efficacy and safety MODERATORS: V.D. Parii, I.B. Pereginets, T.M. Dumenko, N.V. Bezdetko 1) Significance of АВС/VEN analysis for ensuring efficient and safe use of medicines V.D. Parii, O.O. Bogomolets National Medical University, Kyiv, Ukraine 2) Availability of essential medicinal products in Ukraine: results of pharmacoepidemiological study (WHO, HAI and MoH Ukraine Joint Project) I.B. Pereginets, WHO/Europe Country Office in Ukraine, Kyiv, Ukraine T.M. Dumenko, PE “The State Expert Center MoH Ukraine”, Kyiv, Ukraine 3) Use of narcotic analgesics: challenges and solutions N.V. Bezdetko, National University of Pharmacy, Kharkiv, Ukraine October 24, 2013 Congress Hall 17.15 – 18.15 Adopting the resolution Closing session ADDRESS OF THE ORGANIZING COMMITTEE: Post-registration Surveillance Board, The State Expert Center MoH, 40, Ushinsky St., 03151, Kyiv, Ukraine, tel/fax +38 044 498 4358; e-mail: irina@dec.gov.ua CONTACT PERSONS: Olena Matvieieva (general information), tel: +38 044 498 4358; matveeva@dec.gov.ua Irina Logvina (general information, abstracts), tel: +38 044 498 4358; irina@dec.gov.ua Olena Smirnova (hotel reservation), tel: +38 044 247 4719, +38 067 656 2767; lena@dinadis.ua Anastasia Baiazitova (an invoice for registration fee), tel: +38 044 247 4719, +38 067 801 7708; anastasia@dinadis.ua