The 2020 Joint UNICEF–UNFPA–WHO Meeting with Manufacturers and Suppliers of Contraceptive Devices, In Vitro Diagnostics, Vaccines and Immunization Devices, Finished Pharmaceutical Products, Active Pharmaceutical Ingredients and Vector Control Products was held virtually in 2020, from Monday 30 November to Wednesday 02 December 2020.
The meeting brought together a wide range of stakeholders — the UN family, manufacturers, quality, safety and efficacy experts, procurement agencies, and international donors — whose combined efforts bring needed health products to vulnerable populations.
Background documents:
Presentations
Day 1
Session 1 - Access to COVID-19 Health Products
Manufacturers perspectives
Session 2 - WHO Policy, Diagnosis & Treatment Guidelines Updates
WHO diagnosis and treatment guidelines updates
- TB diagnosis & treatment guidelines update
- HIV and STI diagnosis & treatment guidelines update
- Hepatitis B and C diagnosis & treatment guidelines update
- Malaria diagnosis & treatment guidelines update
- Non-communicable diseases diagnosis & treatment guideline update
WHO Model list updates
- The 3rd WHO model list of essential in vitro diagnostics & priority medical devices and PPE for COVID-19
- The 21st WHO model list of essential medicines
Day 2
Parallel Session 3.1 WHO Prequalification Update – In Vitro Diagnostics
- Introduction to IVD update
- Dossier assessment
- Performance evaluation
- Labelling Review and Public Reports
- Technical guidance and specifications
- Collaborative Registration Procedure (CRP)
- IT Update
- Emergency Use Listing (EUL)
Parallel Session 3.2 WHO Prequalification Update – Medicines
- Introduction to medicines assessment update
- Quality
- Bioequivalence
- Active pharmaceutical ingredients
- Update on WHO public assessment reports
- Biosimilar products pilot
Parallel Session 3.3 WHO Prequalification Update – Vaccines & Immunization Devices
- WHO vaccines prequalification overview
- Vaccine assessment
- Vaccines testing
- Post-prequalification
- Prequalification of immunization equipment: implications for vaccines
Parallel Session 3.4 WHO Prequalification Update – Vector Control Products
- Beyond 5 years: moving prequalification of vector control products programme forward
- Prequalified products: submission workload and key projects
Parallel Session 3.5 WHO Prequalification Update – Inspections
- Introduction to inspections update
- Update on activities of inspections including quality guidelines expectation
- Business continuity plan
- Inspections in emergency situations – tools to use
- GMP expectations at antimicrobial manufacturing sites
Parallel Session 3.6 UNFPA Prequalification Update – Contraceptive Devices
- UNFPA Prequalification programme update
- Remote inspections
- Partnerships - Eco-friendly condom packaging
- Quality monitoring strategies
- Manufacturers feedback
Session 4 WHO Collaborative Registration Procedure Update
Day 3
Session 5 WHO Local Production & Assistance
- Introduction
- Leveraging and cultivating enabling factors for local production
- Strategies toward WHO Prequalification
- Technical assistance for IVD manufacturers
- Technical assistance for medicines manufacturers
Parallel Session 6.1 WHO Regulatory Updates
Promoting and enhancing the use of reliance
- Good Regulatory Practices and regulatory flexibilities/agility
- Good Reliance Practices and examples in pharmacovigilance and lot release
- The WHO Listed Authorities: framework and ongoing work
Hot Topics
- Electronic transfer of safety data
- Reporting of adverse events and incidents for products purchased by UN organizations through tenders
- Post-market and market surveillance of medical devices, including IVDs
Parallel Session 6.2 Procurement Overview
Overview on procurement and market strategies for key products, forecasting/quantified need, tenders, available funding 2021-2022 and beyond
- UNFPA - Procurement at UNFPA: contraceptives, priority maternal health products and other RH medical products
- UNDP Procurement update
- WHO Procurement update
- UNICEF - Market overview for key essential medicines for children, Bed nets, In Vitro Diagnostics and vaccines
- Global Drug Facility 2020 update
- Global Fund Procurement update
- PAHO - Sustaining Health Access in the Americas