Name: 11th Annual Meeting on Collaborative Registration Procedure (CRP): Reliance through Facilitated Product Introduction
Start: 2023-12-11T08:00:00+03:00
End: 2023-12-13T15:00:00+03:00
Location: Hilton Hotel Doha

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

from Monday 11 December 2023 (08:00) to Wednesday 13 December 2023 (15:00)

Monday 11 December 2023
08:00 Morning Session
Morning Session
08:00 - 14:00
Contributions

08:00 Arrival of participants and Registration to CRP Annual Meeting - All

09:00 Opening session - keynote address - Hiiti Sillo (Team Lead, WHO Regulation and Safety ) Rayana Ahmad Bou Haka (WHO Representative of Qatar )

09:20 Introduction of participants - Marie Valentin (WHO, Team Lead, Facilitated Product Introduction Team)

09:30 Overview of the objectives, agenda and logistics/housekeeping - Marie Valentin (WHO, Team Lead, Facilitated Product Introduction)

09:40 Plenary 1: High level panel on Facilitated Regulatory Pathways - Alireza Khadem Brooderji (WHO, Regulatory Systems Strengthening) Ann Ottosen (United Nations Children`s Fund ) Deusdedit Mubangizi (WHO Unit Head, Prequalification ) Jackson Hungu (UNITAID) Marie Valentin (WHO Team Lead, Facilitated Product Introduction ) Murray Lumpkin (Bill and Melinda Gates Foundation )

11:30 Plenary 2: Facilitating national medical products registration through Collaborative Registration Procedure (CRP) - Laurent Patern Tshimpaka (Autorité Congolaise de Réglementation Pharmaceutique) Mariana Roldão Santos (WHO, Technical Officer, Facilitated Product Introduction) Naira Romanova (Scientific Centre of Drug and Medical Technology, Armenia) Rutendo Kadzunge (Medicines Control Authority, Zimbabwe) Rwanda FDA (Rwanda FDA) Tanapon Wongkaew (Thailand Food and Drugs Administration )
14:00 Afternoon Session
Afternoon Session
14:00 - 21:30
Contributions

14:00 Plenary 3: Perspectives from the Partners, RECs and SRA - Alex Juma (AUDA-NEPAD) Ann Ottosen (United Nations Children`s Fund) Azri Nasruddin (ASEAN) Charles Preston (Bill and Melinda Gates Foundation) Cherise Scott (UNITAID) Karen Loft (Therapeutic Goods Administration) Kerrine Ottley (CARPHA CRS) Sandra Ligia (Advanced Medical technology Association, ADVAMED)

16:00 Workshop 1: Experience sharing from Industry and recommendations - Giulia di Persio (ViiV Healthcare) Janis Bernat (International Federation of Pharma Manufacturers and Associations) Laurence Descourvieres (Abbott Diagnostics Medical Co.  ) Sandhya Jadhav (Macleods Pharmaceutical Limited) Sandra Ligia González (Advanced Medical Technology Association, ADVAMED) Sebastian Comellas (Developing Countries Vaccines Manufacturing Network) Suzette Kox (International Generic and Biosimilar Medicines Association (IGBA)) Viviane Robbrecht (Janssen Pharmaceuticals)
Tuesday 12 December 2023
09:00
09:00 - 15:00
Contributions

09:00 Workshop 2: Interactive sessions in groups - All

11:00 Workshop 3: WHO Prequalification - Lawrence Nzumbu, (WHO Prequalification, Medicines) Olivier Lapujade (WHO Prequalification, Vaccines) Stephanie Croft (WHO Prequalification, Inspections) Susie Braniff ( WHO Prequalification, In vitro diagnostics)

14:00 Workshop 4: Overview of SRA approaches and pathways in the assessments of medical products - Karen Loft (Therapeutic Goods Administration ) Victoria Palmi (European Medicines Agency (EMA) )
15:00
15:00 - 17:00
Contributions

15:00 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)

16:15 Workshop 5: Application of reliance-based approaches in GMP Inspections and site Quality Audits
Wednesday 13 December 2023
08:30
08:30 - 11:00
Contributions

08:30 The Collaborative Registration Procedure in practice – 2023 perspectives

09:00 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

09:00 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)
11:00 Coffee Break
Coffee Break
11:00 - 11:30
11:30
11:30 - 12:30
Contributions

11:30 Tools to support implementation of CRP including the Electronic Prequalification System
12:30 Lunch
Lunch
12:30 - 13:30
13:30
13:30 - 14:30
Contributions

13:30 Closing plenary - Marie Valentin (WHO Team Lead Facilitated Product Introduction )

14:15 Closing Remarks - Marie Valentin (WHO Team Lead Facilitated Product Introduction )

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