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11th Annual Meeting on Collaborative Registration Procedure (CRP): Reliance through Facilitated Product Introduction

11–13 Dec 2023
Hilton Hotel Doha
Asia/Qatar timezone
CRP Impact and Future Prospects for Countries and Patients

Contact:

Session

Closed Session to NRAs only

12 Dec 2023, 15:00
Hybrid
Hilton Hotel Doha, Doha, Qatar

Hilton Hotel Doha

Diplomatic District Street I West Bay Area I P O Box 24572 I Doha I Qatar
https://who.zoom.us/meeting/register/tJAlfu-vpjwpGtTJOf3mPuOO_90IWKIZ8_Az

Conveners

Closed Session to NRAs only

  • Marie Valentin

Closed Session to NRAs only

  • There are no conveners in this block

Description

Moderators:
Marie Valentin, Team Lead, WHO FPI (Day 2)
Ann Ottosen, United Nations Children`s Fund (Day 3)

Presentation materials

There are no materials yet.
23. Plenary 4: Practical examples of NRA’s good practices for implementation of CRP and recommendations
Ali Arale (Pharmacy and Poison Board, Kenya), Beatrice Ayim (Ghana Food and Drugs Authority ), Jonathan Oghene Uviase (Nigeria Food and Drugs Administration ), Ntsetselele Kago (Botswana Medicines Regulatory Authority), Sakeni Hadebe (Zambia Medicines Regulatory Authority)
12/12/2023, 15:00

Moderator: Phillipe Doo-Kingue, WHO Regional Office for Africa, AFRO

Presentation of max 5 minutes each NRA followed by 15 minutes for Q&A
24. Workshop 5: Application of reliance-based approaches in GMP Inspections and site Quality Audits
12/12/2023, 16:15

Moderator: Joseph Kabatende, WHO Regional Office for Africa, AFRO
Facilitator: Stephanie Croft, WHO Prequalification, Inspections

  • Existing Reliance in site inspections and audits
  • GMP desk assessments: recommendations and methods
  • Quality Audits desk assessments: recommendations and methods

Presentation (15 minutes) followed by illustration of desk assessment templates and...
29. The Collaborative Registration Procedure in practice – 2023 perspectives
13/12/2023, 08:30

Facilitator: Agnes Kijo, Technical Officer, WHO Facilitated Product Introduction

  • Best practices
  • Specific national requirements
  • Communications
  • Risk based assessments and inspections

Presentation (15 minutes) followed by 15 minutes discussion
17. Workshop 6: Road trip to a successful assessment and regulatory decisions -essential tips: Parallel Session 2: Product dossier verification and Abridged assessments – In Vitro diagnostics
13/12/2023, 09:00

Moderator: Agnes Kijo, WHO Facilitated Product Introduction Team
Facilitator: Gudula Mpanda, Tanzania Medicines and Medical Devices Authority

Mix of presentations, activities (demo tools), experiences shared, Q&A and breaks
Close of session: 5 minutes for moderators to close the session
Feedback and Discussion in Plenary
16. Workshop 6: Road trip to a successful assessment and regulatory decisions -essential tips: Parallel Session 1: Product dossier verification and Abridged assessments - Medicines and Vaccines (PQ and SRA)
13/12/2023, 09:00

Moderator: Dorina Pilgari, WHO Regional Office for Europe, EURO
Co-Moderator: Mariana Roldão Santos, WHO Technical Officer, Facilitated Product Introduction Team

Facilitator: Rutendo Kadzunge, Medicines Control Authority of Zimbabwe

Mix of presentations, activities (demo tools), experiences shared, Q&A and breaks
Close of session: 5 minutes for moderators to close the...
27. The Collaborative Registration Procedure in practice – 2023 perspectives
13. Workshop 2: Interactive sessions in groups
Global Fund
  • Case Study 1: Facilitated registration pathways
  • Case Study 2: National registration system
  • Case Study 3: Applying facilitated pathways in public health emergencies
  • Case Study 4: CRP Tools
14. Workshop 5: Application of reliance-based approaches in GMP Inspections and site Quality Audits
  • Existing Reliance in site inspections and audits
  • GMP desk assessments: recommendations and methods
  • Quality Audits desk assessments: recommendations and methods

Presentation (15 minutes) followed by illustration of desk assessment templates and requirements (20), followed by Q&A (10 minutes)
Building timetable...
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