The 2022 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers took place from 28 November to 1 December 2022 at UN City, Marmorvej 51, 2100 Copenhagen, Denmark and the theme of the 2022 Joint UNICEF-UNFPA-WHO Meeting was: "Global Health Supplies: Paradigm Shifts in Market Authorization, Procurement and Supply Chain Approaches".
Draft Agenda
- Draft Agenda (Version of: 29 November 2022)
Presentations
Day 1 - Monday, 28 November
Session 1
Session 2 - New and Complex Products, Complex Processes
- Product Evaluation Perspective - The Insulin Case
- Procurement and Supply Chain Perspective
- Innovator Industry Perspective
- Generic Industry Perspective
Session 4 - Regional Procurement and Enabling Regulatory Arrangements
- Outline Session 4
- Perspectives from UNICEF
- Procurement at WHO
- PAHO regulatory arrangements to support regional procurement: reliance in practice
- The African Medicines Regulatory Harmonization Initiative & African Medicines Agency
- Accelerating Equitable Access to Health Innovations - Market-based approach to enhancing domestic and regional manufacturing capacity in Africa
Wrap-up Day 1
Day 2 - Tuesday, 29 November
Session 5.1 - Prequalification In Vitro Diagnostics
- WHO Prequalification Update 2022
- NATs to detect Mycobacterium Tuberculosis DNA: TSS 17, Dossier Review, Performance Evaluation & Next Steps
- Website walk through - PQ IVD pages, PQ list, EUL list, Guidance documents, Newsletter & Next Steps
- Development of new technical specifications for PQ (TSS): Blood glucose monitoring devices and HbA1c POC devices
- ToC dossier submission
- EUL: Progress, Challenges & Plans
Session 5.2 - Prequalification of Medicines
- Prequalification Team Medicines (PQT/MED) - Update
- Finished Pharmaceutical Product (FPP) - Quality Update
- Active Pharmaceutical Ingredient (API) Assessment Update & ePQS update
- Bioequivalence Assessment Update
- Prequalification of biotherapeutic and biosimilar products
- Update on WHO Public Assessment Reports
Session 5.3 - Prequalification of Vaccines
- WHO vaccines prequalification overview
- Vaccine assessment: CMC (chemistry, manufacturing and control), quality and post PQ activities and clinical data
- Programmatic suitability for Prequalified Vaccines (PSPQ)
- WHO PQ: Clinical requirements
- Risk benefit assessment procedures - updates on EUL
- WHO VAX IMD Overview: The immunization cold chain’s first line of defence
- Post Prequalification Activities
- Prequalification of Vector Control Products (PQT/VCP) Updates
- Non-inferiority assessments of insecticide-treated nets
Session 5.5 - UNFPA Prequalification of Contraceptive Devices & Markets Track
- Updates from WHO/UNFPA Prequalification Programme
- Summary of Quality complaints for 2021
- Review of 2021 Annual Reports of Significant Changes
- Process capability indices and control charts. A practical overview of their application
- UNFPA Guidance and SOP on referee testing
Session 6 - Prequalification Inspection Services
- Overview of WHO Prequalification Inspection Services
- Antimicrobial Resistance and Management of Waste from Pharmaceutical Manufacturing
- UN Sustainable Development Goals and Application to PQT Inspections
- Inspection & Review of CROs’ computerized systems validation
- Implementation of the updated Annex 1 for the Manufacture of Sterile Medicinal Products – Key Considerations for Senior Management
Session 7 - Local Production & Technical Assistance
- Universal Corporation Limited [UCL], Kenya Insight to Local Manufacturing
- Case study: Production of IVDs - The Institut Pasteur de Dakar experience
- Connecting Vector Control Product Assessment and LPA
- UNICEF Support to Local Manufacturing and Procurement
- Case Study: Clinical development in Africa
- PQ/EUL-related specialized technical assistance for pharmaceutical products (medicines)
- WHO PQ/EUL specialized technical assistance - Focus on vaccines
Day 3 - Wednesday, 30 November
Session 8 - Procurement and Supply Chain: Updates, Challenges and Solutions
- UNFPA Procurement: Generating Access to Quality Assured Reproductive Health Commodities
- UNDP Global Health Procurement and Supply Chain Architecture
- Procurement and Supply Chain World Health Organization (WHO)
- UNICEF Procurement: Comprehensive supply for impactful and cost-efficient health programmes
- Global Fund Procurement & Supply Updates
- Promoting Access to TB Products: GDF’s End-to-End Approach
Session 9.1 - Verification, Visibility and Traceability
- Introduction to the VTI and TRVST
- Traceability in the health sector
- UNFPA adoption to Global Data Standards for Reproductive Health Supplies
Session 9.2 - Opportunities, Challenges and Solutions Towards Achieving Sustainable Transport Worldwide
Session 9.3 - Updates on Treatment Guidelines & Diagnostics Guidelines, Essential Medicines List and Essential Diagnostics List
- Accelerating innovation and access to paediatric medicines
- Living Guidelines for Clinical Management of COVID-19:update from the 12th edition
- Update on viral hepatitis B and C – testing and treatment
- WHO update for rapid test and self-testing guidelines for HIV and STIs
- Update on WHO TB guidelines
- Sexual and Reproductive Health Guidelines
- WHO AWaKe Antibiotic Book
Session 10 - Regulatory Updates
- Introduction
- WHO Listed Authorities (WLA) and promoting reliance
- Facilitated Registration Pathways and the Collaborative Registration Procedure (CRP)
- Pharmacovigilance and information exchange - ensuring the safety and uptake of vaccines and medicines in a public health emergency
- Post-market and market surveillance of medical devices including IVDs
- Norms and Standards for Product Regulation