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2024 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers

Event
Meeting
ID
IVD
IS
M
V
VCP
2 - 6 December, 2024 - 08:00 - 18:00 (CET)
UN City, Copenhagen,
Denmark

The United Nations Children Fund (UNICEF), the United Nations Population Fund (UNFPA) and the World Health Organization (WHO), held the annual 2024 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers from 2 to 6 December 2024 at UN City, Copenhagen, Denmark.  

The theme of this year’s meeting was Ensuring Health Equity: "Partnerships for Accessible Quality Products". 

Should you have any questions regarding the 2024 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers, please do not hesitate to contact us at prequal@who.int.

Agenda

2024 Presentations

Day 1

Session 1
  1. How to Use the Event Application
  2. Session Introduction
  3. Meeting Objectives and Outline
Session 2
  • No presentations - Plenary Discussion - Check video "On-Demand" on the Event App
Session 3
  1. WHO’s role in strengthening the sustainability and quality of local production and technology transfer
  2. WHO Health Technology Access Program (HTAP) –  A targeted approach to bridging the access gap
  3. Overcoming the challenges in local production to improve timely access of diagnostics
  4. Overcoming the challenges in local production to improve timely access of pharmaceuticals
  5. Overcoming the challenges in local production to improve timely access of vaccines
Session 4
  1. Technology and Collaboration for Global Health
Closing Day 1
  1. Closing Plenary

Day 2

Session 5.1 - Prequalification of Diagnostics (PQT/IVD)
  1. In Vitro Diagnostics Assessment Team: Update
Session 5.2 - Prequalification of Medicines (PQT/MED)
  1. Introduction
  2. Update
  3. Bioequivalence Assessment Update
  4. Prequalification of biotherapeutic and biosimilar products
  5. API Assessment Update & ePQS Update
  6. Update on WHO Public Assessment Reports (WHOPARS)
Session 5.3 - Prequalification of Vaccines (PQT/VAX)
  1. WHO Vaccines PQ Overview
  2. Prequalification of Vaccines - CMC
  3. Prequalification of Vaccines - Clinical Requirements
  4. Prequalification of Vaccines - Programmatic Suitability
  5. Prequalification of Vaccines - Risk Benefit Assessment Procedures
  6. Prequalification of Vaccines - ePQS & eCTD
Session 5.4 - Prequalification of Vector Control Products (PQT/VCP)
  1. Prequalification of Vector Control Products - Updates
Session 5.5 - UNFPA/WHO Prequalification of Contraceptive Devices
  1. Updates
  2. Review of Condom Customer Complaints 2023
  3. Review of Significant Changes by Condom Manufacturers 2023
  4. Specifications for Copper IUDs Variations
  5. Eco-friendly Condom Production
  6. Best Practices & Sustainability
  7. Innovative Projects on Condom Packaging Presentations
  8. Problems of Condom Supplies to High Altitude Locations
  9. Personal Lubricants & Osmolality
  10. Heating Ventilation and Air Conditioning Recommendations for Personal Lubricant Manufacture (HVAC)
  11. Update on Revision of ISO 4074 Ed. 4
Session 6 - Prequalification Inspection Services
  1. Introduction to WHO Prequalification Inspection Services
  2. Inspection Trends of API and FPP Manufacturing Sites and Quality Control Laboratories
  3. Good Document Practice in Bioequivalence Studies
  4. Vaccines Inspection Updates
  5. Update on Medical Devices Inspections
  6. Vector Control Products
  7. Desk Assessment and Reliance Approaches
  8. Update on new guidelines, DEG/EG Contamination, and the Use of New Technologies
Session 7 - Local Production & Technical Assistance
  1. PQ/EUL Related Specialized Technical Assistance
  2. PQ/EUL Related Specialized Technical Assistance for Diagnostics
  3. Specialized Technical Assistance (STA) for Medicines
  4. Specialized Technical Assistance (STA) for Vaccines

Day 3

Sessions 9 & 10 - Procurement & Supply Chain Updates
  1. World Health Organization - Procurement Overview
  2. The Global Fund's Procurement System
  3. Promoting Access to TB Products - GDF's 2024 Updates
  4. UNFPA Procurement and Strategic Sourcing
  5. Medical Procurement in UNHCR
  6. UNDP Global Health Procurement and Supply Chain Architecture
  7. Overview of PAHO Regional Revolving Funds
  8. UNICEF Supply Priorities Medicines
  9. Becoming a Supplier to UNICEF - Steps for Successful Engagement: Tendering and Contracting
  10. Becoming a Supplier to UNICEF - Steps for Successful Engagement - Quality Assurance for Pharma
  11. Becoming a Supplier to UNICEF - Technical Requirements for Pharmaceutical Products
  12. Traceability and Verification - TRVST Traceability & Verification System for Health Products
  13. Sustainable Procurement - Building Sustainable Supply Chains at UNICEF to Ensure a Live-able Planet for Every Child
  14. UNICEF Supply - Highlights & Priorities
  15. Last Mile Assurance and Supply Chain - Systems Strengthening
  16. UNFPA Product Quality Assurance
  17. Enhancing Collaboration Between Manufacturers and Global Procurers

Day 4

Session 11 - Regulatory Updates
  1. Implementing the WHO-listed Authority Framework - Achievements-Challenges-Benefits
  2. Experience and Perspective of WHO Collaborative Registration Procedure
  3. Norms and Standards for Biological Products: An Update
  4. Norms and Standards for Pharmaceuticals: An Update
Session 12 - Treatment and Diagnostic Guidelines, Essential Medicines Lists (Inc for Children), Essential In Vitro Diagnostics List
  1. Update on WHO TB Guidelines
  2. What Is New In Treatment and Diagnostics Guidelines - HIV, Viral Hepatitis and Sexually Transmitted Infections
  3. Non-Communicable Diseases (NCDs) - Global Context and Update
  4. Sexual and Reproductive Health and Research Department Update
  5. WHO Model List of Essential In Vitro Diagnostics
  6. WHO Model List of Essential Medicines
  7. Updates on Malaria: Diagnostics, Medicines and Vaccine
  8. World Health Emergencies and Living Guidelines
  9. Neglected Tropical Diseases (NTDs) Guidelines Update
Session 13 - Requirements for Storage and Transportation of Time and Temperature Sensitive Health Products
  1. Requirements for Storage and Transportation of Time and Temperature Sensitive Health Products (Temperature Control and Monitoring of Shipments)
  2. Innovations in Transportation of Time and Temperature-Sensitive Healthcare Products (TTSHP)
  3. UNICEF Supply Chain Delivery Strategy
Session 14 - PAHO Presentation & Official Closing
  1. PAHO - Regional Regulatory Systems and Innovation and Production Agenda

 

NTD-IVD Workshop

Day 1
  1. WHO NTD Diagnostics Technical Advisory Group
  2. WHO Target Product Profiles (TPP) - Process and Implications for WHO NTDs
  3. Access to NTD Diagnostics and WHO Response
  4. WHO Expert Review Panel for NTD Diagnostics (ERPD NTD)
Day 2
  1. Introduction to WHO Prequalification of In Vitro Diagnostics
  2. PQ Guidance Documents and ERPD Overview
  3. The ISO 13485: 2016 QMS - A Framework for a Safe, Efficient, and Effective IVD Medical Device(s)
  4. WHO Collaborative Registration Procedure for In vitro Diagnostics (CRP for IVDs)
  5. Post-Market Surveillance for IVDs
  6. WHO Health Technology Access Program (HTAP) – A Targeted Approach to Bridging the Access Gap