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:
  • Obstacles in the ODS phase-out process in the MDI sector and how to overcome them.
  • Technical solutions to substitute ODS the two industrial units in the Russian Federation, i.e. JSC Altayvitaminy and JSC Moschimpharmpreparaty.
  • Problems associated with replacement of old MDIs in the Russian Federation and CISs.
  • National Transitional Strategies in the CIS countries
18.00 Closure of the EGM