JOINT UNICEF PHARMACEUTICAL SUPPLIER MEETING & WHO PREQUALIFICATION OF MEDICINES PROGRAMME 3RD MEETING WITH MANUFACTURERS OF FINISHED PHARMACEUTICAL PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS
24-26 SEPETEMBER 2012
UNICEF and WHO held a global consultation with pharmaceutical manufacturers on Monday 24 and Tuesday 25 September 2012 in Copenhagen. The consultation combined two meetings that are regularly organized by UNICEF Supply Division and the WHO Prequalification Programme with pharmaceutical manufacturers and partners in an effort to expand the participation to the meetings and increase efficiency.
UNICEF’s consultation aimed at presenting and discussing with industry and partners the priority health programme that contribute to child health and survival as well as the needs these programmes have for appropriate affordable medicines of assured quality. Specific topics of interest included the UN Commission for Live-saving commodities for women and children, efforts to scale-up treatment of diarrhoea and pneumonia and the priorities for elimination of mother to child transmission of HIV.
The WHO Prequalification consultation provided updates on the WHO Prequalification Programme and included technical seminars on specific topics as well as meetings with assessors.
Shanelle Hall, Director of UNICEF Supply Division, welcomed the representatives of over 100 companies and organisations from Europe, Asia, Africa, and America.
Participant list here. Agenda can be found here.
Monday 24 September
Session 1: Opening of meeting
09:15 Welcome and opening remarks: Shanelle Hall, Director , UNICEF Supply Division
09:30 Administrative arrangements: Charlotte Thaarup, Administrative Assistant, UNICEF Supply Division
Session 2. Access to Essential Medicines for Women and Children- UNICEF priorities
Chair: Shanelle Hall.
09:45 Review of UNICEF work in procurement and supply of medicines: Francisco Blanco, Chief Medicines and Nutrition Centre, UNICEF Supply Division
10:15 Priority actions for increasing availability, affordability, accessibility and rational use of essential commodities for women’s and children’s health: UN Commission on Life-saving Commodities for Women and Children: Hanne Bak Pedersen, Deputy Director, UNICEF Supply Division
11:30 Strategies to control pneumonia, diarrhoea and malaria: Mark Young, Senior Health Specialist, UNICEF Programme Division
12:00 Innovation for elimination of mother-to-child transmission of HIV: Chewe Luo, Senior Health Specialist, HIV , UNICEF Programme Division
Session 3. Demand and markets for quality medicines Chair: Lembit Rägo, WHO/EMP
14:00 Opening remarks: Kees de Joncheere, Director, WHO Department of Essential Medicines and Pharmaceutical Policies (WHO/EMP)
14:15 How prequalification makes a difference and why it is still needed: Ellen‘t Hoen (IS Academy HIV/AIDS, School for Social Science Research, University of Amsterdam)
14:35 Pharmaceutical procurement: covering Global Fund to Fight AIDS, Tuberculosis and Malaria (Joelle Daviaud); UNICEF (Francisco Blanco); UNFPA (Eric Dupont); Global Drug Facility (Paloma Marroquin Lerga); USAID (Mike Hope); UNDP (Jacqueline Pontre); AIDS Medicines & Diagnostics Service (Boniface Dongmo Nguimfack); UNITAID (Dr Philippe Duneton)
16:45 WHO Expert Review Panel: bringing needed products to market: Matthias Stahl, Head of Assessment, PQP
17:15 Discussion and questions
Tuesday 25 September
Session 4. UNICEF review of operations including quality assurance issues
Chair: Hanne Bak Pedersen, UNICEF Supply Division
09:00 Review of operations related to medicines: procurement process, projects, tenders, efficiency: David Muhia/Gitanjali Sakhuja/Karin Thomsen, UNICEF. An overview of top product purchases can be found here.
10:30 Overview of UNICEF’s quality assurance system for procurement of medicines: Peter Svarrer Jakobsen, UNICEF
11:30 Technical requirements for medicines: Henrik Nielsen, UNICEF
12:00 Requirements for warehouse orders: planning, packing and shipping: Susanne Fraisse, UNICEF
12:30 Closing remarks: Hanne Bak Pedersen, UNICEF
Session 5: Prequalification Assessment Procedures & Guidelines
Chair: Matthias Stahl, PQP
14:00 Quality assessment update: Lynda Paleshnuik, Health Canada & external assessor
14:30 BE assessment update: John Gordon, Health Canada & external assessor
14:50 API assessment update: Antony Fake, PQP
From the manufacturers’ point of view
Chair: Valérie Faillat-Proux, Sanofi
16:00 Short presentations by manufacturer representatives: Venkatesh Katgeri (Cipla Ltd); Kavita Sehwani (Ipca Laboratories Ltd); Alex Zheng (Beijing Holley-Cotec Pharmaceuticals Co., Ltd); Kunle Okelola (Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria)
17:00 Discussion and questions
Wednesday 26 September
Session 6: Inspections: Problem Areas for Manufacturers
Chair: Ian Thrussell, PQP Achieving good manufacturing practice
09:00 Examples of critical and major observations from GMP inspections of manufacturing sites, quality control laboratories and contract research organizations: Ian Thrussell, PQP
09:45 Discussion - Optimizing Prequalification Impact for Patients, Manufacturers & National Medicines Regulatory Authorities
10:30 Accelerated procedure for registration of WHO-prequalified medicines: Milan Smid, PQP
11:00 Discussion
Please contact Charlotte Thaarup (cthaarup@unicef.org) for any further details.
