Programme

Programme Overview - Virtual ICDRA 2021 (pdf)

137 KB

Detailed Programme Overview - Virtual ICDRA 2021 - with list of Moderators/Co-Moderators and Panelists (pdf)

172 KB

Presentations

Day 1 - Monday, 20 September 2021

Plenaries

Plenary 1 - WHO report on 18th ICDRA (pdf)

958 KB

Plenary 2 - Global Benchmarking Tool & WHO Listed Authorities (pdf)

2224 KB

Day 2 - Tuesday, 21 September 2021

Plenaries

Plenary 3 - Emergency Use Listing (EUL) Medicines, Vaccines and IVDs including Inspections during the COVID-19 Pandemic (pdf)

154 KB

WHO EUL-Principles, Process and Lessons Learnt (pdf)

769 KB

Considerations and Best Practices for Addressing Public Health Emergencies (pdf)

290 KB

Assessment of Vaccines and Medicines Using Emergency Use Authorization: Anvisa perspectives (pdf)

744 KB

Regulatory Experience with using regulatory Tool of Remote Assessments and Hybrid Inspections (pdf)

1060 KB

Industry Experience with Remote Assessments (Inspections) and Going Back to Normal (pdf)

376 KB

Perspective on the utilization of the EUL process - Botswana Medicines (pdf)

600 KB

Day 3 - Wednesday, 22 September 2021

Plenaries

Plenary 4: Facilitated Registration of Medical Products (pdf)

310 KB

Parallel Workshops

Access to Medical Product: Regulatory flexibilities/agilities during Public Health Emergencies (pdf)

290 KB

Post-approval Changes in the Overall Products Life Cycle (pdf)

144 KB

Day 4 - Thursday, 23 September 2021

Parallel Workshops

Pharmacovigilance/Medical Products Safety (pdf)

1394 KB

Local production to improve access: Lessons learnt from the Pandemic - Developing Countries Vaccine Manufacturers Network (DCVMN) (pdf)

306 KB

Local Production Building Regulatory Agility for Local Production to Combat Pandemics: An Industry Perspective - IFPMA (pdf)

284 KB

Local Production Building Regulatory Agility for Local Production to Combat Pandemics: An Industry Perspective - Bio Farma Indonesia (pdf)

1809 KB

African Blood Regulatory Forum (ABRF) - (TWG) Update (pdf)

660 KB

WHO Action Framework to Advance Universal Access to Safe, Effective and Quality Assured Blood Products 2020-2023 (pdf)

1001 KB

WHO-Advisory Group on Blood Regulation, Availability and Safety (pdf)

518 KB

Day 5 - Friday, 24 September 2021

Parallel Workshops

Good Regulatory Practices (GRP) and Good Reliance Practices (GRelP) (pdf)

1824 KB

Good Regulatory Practices (GRP) and Good Reliance Practices (GRelP) - PAHO (pdf)

309 KB

Medical Devices including in vitro diagnostics: Impact of Reliance Approaches in Accelerating Product Introduction during the COVID-19 Global Pandemic (pdf)

1068 KB

Recommendations

Plenary 5 - Recommendations (Virtual) ICDRA 2021 (pdf)

212 KB