Regional expert group meeting (EGM). Elimination of CFCS contained in aerosol metered dose inhalers (MDI) in the commonwelath of independent states (CIS)
September 30, 2011
4-5 October, 2011
International Centre for Scientific and Technical Information
Day 1
| Chairmen: Mr. Yury Sorokin, Industrial Development Officer, UNIDO | ||
|---|---|---|
| 9:00–10:00 | Registration | |
| 10:00–10:25 | Opening statement, Deputy to Minister, Ministry of Health and Social Development of the Russian Federation, Moscow Opening statement, Mr. Yury Sorokin, Industrial Development Officer, UNIDO Opening statement, Ms. Marya Volosatova and Mr. Sergey Vassiliev. Ministry of Natural Resources and Environment of the Russian Federation |  |
| 10:25–10:50 | Legal framework of Montreal Protocol, Mr. Vassily Tselikov, National Expert, UNIDO | |
| 10:50–11:15 | Establishment of the state system for regulation of turnover of ozone-depleting substances and products containing them within the territory of the Russian Federation, Ms. Marya Volosatova, Head of the Section of Climate and Atmospheric Air of the Department of State Policy and Regulation in Hydrometeorology and Environmental Monitoring of Ministry of Natural Resources and Environment of the Russian Federation | |
| 11:15–11:40 | Production and import of MDIs in the Russian Federation, representatives of JSC Altayvitaminy and JSC Moschimpharmpeparaty. | |
| 11.40–12.00 | Coffee break | |
| 12:00–12:25 | State Drug Quality Control System, Drug Quality Specifications for Metered-Dose Inhalers and Their Components, Ms. Alla Trapkova, Deputy Head of the Department for the Organization of State Quality Control for Health Care Products | |
| 12:25–12:50 | National Transitional Strategy to replace CFC-based MDIs with HFA MDIs in the Common wealth of Independent States, Mr. Paul Krajnik, Industrial Development Officer, UNIDO | |
| 12:50–13:15 | GEF/UNIDO Project - Phase-out of CFC consumption in the Manufacture of Aerosol Metered Dose Inhalers (MDIs) in the Russian Federation, Mr. Victor Shatrauka, Consultant | |
| 13:15–13:40 | Conversion to non-CFC production of MDIs at JSC Moschimpharmpreparaty, Mr. Oleg Sorokin, Production Manager, JSC Moschimpharmpreparaty | |
| 13:40–14:05 | Conversion to non-CFC production of MDIs at JSC Altayvitaminy, Mr. Alexey Zalesov, Expert, JSC Altavitaminy | |
| 14:05–15:00 | Lunch break /Обед | |
| 15:00–15:25 | Viable alternatives to conversion to non-CFC MDI, problems associated with conversion to HFA at two Russian enterprises, Mr.Victor Shatrauka, consultant | |
| 15:25–15:50 | Physical and chemical testing methods validation in Metered Dose Inhaler production and development, Dr. Gyula Kortvelyessy, UNIDO Consultant | |
| 15:50–16:15 | Problems of ODS-containing drug turnover in the Kyrgyz Republic, Mr. Djanyl Djusupova, First Deputy Director General of the Department of Drug Provision and Medical Equipment of the Ministry of Public Health of the Kyrgyz Republic | |
| 16.15–16.30 | Coffee break | |
| 16:30–16:55 | Specifics of registration of new MDI in the Russian Federation, Ms. Alla Sheshukova, Assistant of the Department of State Control for Drug Circulation of the Ministry of Public Health and Social Development of the Russian Federation | |
| 16:55–17:20 | Technical requirements to Good Manufacturing Practices (GMP) by manufacture of MDIs, Dr. Gyula Kortvelyessy, UNIDO Consultant | |
| 17:20–17:55 | OJSC Pharmaceutical Factory of St-Peterburg is the first Russian manufacturer of non-freon dosed aerosol medicines, Karavaeva Anastasia | |
Day 2
| Chairmen: Mr. Cameron Murdoch, Murdoch Consulting Ltd, UNIDO Consultant | ||
|---|---|---|
| 10:00–10:25 | COSTER: Making MDI valves, actuators and filling equipment suitable for HFA, Fabio Barozzi , Deputy General Manager, Machinery Division, Coster; Bianca Cavalli – Sales & Marketing Manager, Pharma Division, Coster | |
| 10:25–10:50 | Pharmaceutical development of metered-dose inhalers (MDIs) with the propellant HFC-134a, Nikolay Lyapunov Doctor of Pharmacy, Professor Chief scientific officer at State Scientific Center of Medicinal Products and Medical Devices; Elena Bezuglaya, Doctor of Pharmacy, Head of laboratory of liquid and semi-solid preparations and aerosols at State Scientific Center of Medicinal Products and Medical Devices (Ukraine) | |
| 10:50–11:15 | UNIDO MDIs development projects. The V.A.R.I & Co. perspective over successfully completed programs, Mr. Gabriele Marchetti, the Technical Manager of VARI SpA, Italy | |
| 11:15–11:40 | Particulars of filling machines design and production, Mr. Urs Hauser, Sales Manager, Pamasol, Switzerland | |
| 11.40–12.00 | Supply of HFA pharmaceutical grade to the production enterprises, Dr. Tim Noakes, Commercial manager, Mexichem, Ltd., UK. | |
| 12:00–12:25 | HFA pMDI Technologies, Mr. Joy Bogaita, Technical Director, Bespak, UK | |
| 12:25–12:50 | Coffee break | |
| 12:50–13:15 | Metering valves for HFA formulations - Factors to Consider, Mr. Chris Baron, Aptar Pharma, Associate Director, Business Development: Asthma & COPD, France | |
| 13:15–13:40 | Marketing and Business opportunities for new MDIs in Commonwealth of Independent States, Representatives of JSC Altayvitaminy. and JSC Moschimpharmpreparaty. | |
| 13:40–15:00 | Lunch break | |
| 15:00–18:00 | Round table discussions:
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| 18.00 | Closure of the EGM | |