Name: 12th Annual Meeting on Collaborative Registration Procedure (CRP): Reliance through Facilitated Product Introduction
Start: 2024-11-12T08:15:00+07:00
End: 2024-11-14T17:40:00+07:00
Location: JS Luwansa Hotel

12th Annual Meeting on Collaborative Registration Procedure (CRP): Reliance through Facilitated Product Introduction

from Tuesday 12 November 2024 (08:15) to Thursday 14 November 2024 (17:40)

Monday 11 November 2024
Tuesday 12 November 2024

08:15 Arrival of participants and Registration to CRP Annual Meeting
Arrival of participants and Registration to CRP Annual Meeting
08:15 - 09:00
Facilitator: Alexandre Buffin, WHO/FPI
09:00 Keynote address
Keynote address
09:00 - 09:30
Contributions

09:00 Remarks from REG Unit Head - Hiiti sillo (WHO/REG)

09:15 Remarks from WHO Representative of Indonesia - WHO CO / Indonesia
09:30 Warm-up exercise for participants in the room: Introduction of participants. Online participants can have a 30-minute coffee break
Warm-up exercise for participants in the room: Introduction of participants. Online participants can have a 30-minute coffee break
09:30 - 10:00
10:00 Overview
Overview
10:00 - 10:30
Contributions

10:00 Overview of the meeting - Marie Anne Nicole Daniele Valentin (WHO)

10:10 CRP Overview - Marie Anne Nicole Daniele Valentin (WHO)
10:30 Morning Coffee Break & Group Photo
Morning Coffee Break & Group Photo
10:30 - 11:00
11:00 CRP: Progress and Achievements
CRP: Progress and Achievements
11:00 - 12:00
Contributions

11:00 PQ CRP Medicines and Vaccines - Sunday kisoma (WHO)

11:15 SRA CRP - Nyasha Lizzie MAREGERE

11:30 PQ CRP IVDs - Agnes Sitta Kijo (WHO)

11:45 "Questions from participants" on the different product streams - Agnes Sitta Kijo (WHO) Nyasha Lizzie MAREGERE Sunday kisoma (WHO)
12:00 Q&A
Q&A
12:00 - 12:30

12:30 Lunch
Lunch
12:30 - 14:00
14:00 Plenary 1
Plenary 1
14:00 - 15:10
Contributions

14:00 Perspectives of WHO and partners - High level panel on Facilitated Regulatory Pathways and CRP - Alireza Khadem Broojerdi (WHO) Ann Egede Ottosen (UNICEF) Lawrence Nzumbu Murray Lumpkin (Bill & Melinda Gates Foundation) Olivier LAPUJADE (WHO) Susie Braniff (WHO) Victoria Palmi (EMA)
15:10 Afternoon Coffee Break
Afternoon Coffee Break
15:10 - 15:40
15:40 Plenary 2
Plenary 2
15:40 - 16:50
Contributions

15:40 Perspectives of NRAs and Industry - Facilitating national medical products registration through Collaborative registration procedure (CRP) - Clifford Shadreck Mwale (The Pharmacy and Medicines Regulatory Authority, Malawi) Eddie Wang FIKRIYE HANDAN OZTUNCA (Turkish Medicines And Medical Devices Agency) Janis Bernat (International Federation of Pharmaceutical Manufacturers and Associations) PQ CRP Industry - DCVMN (TBC) Thabo Bryan Bokhutlo (Botswana)
16:50 End of Day 1
End of Day 1
16:50 - 17:00

19:00 Reception
Reception
19:00 - 21:00
Wednesday 13 November 2024
09:00 Group 1 NRAs: CRP for Medicines, Vaccines and Biotherapeutics
Group 1 NRAs: CRP for Medicines, Vaccines and Biotherapeutics
09:00 - 13:00
Contributions

09:00 Overview of CRP pathways and implementation - Ayumi Endo (Pharmaceuticals and Medical Devices Agency, Japan) Lawrence Nzumbu Natasha Brockwell (TGA) Nyasha Lizzie MAREGERE Sakeni Hadebe (Zambia) Tharnkamol Chanprapaph (Thailand) Victoria Palmi Reig (Netherlands (Kingdom of the)) Yuriko Takemura
Group 2 NRAs: CRP for In-Vitro Diagnostics
Group 2 NRAs: CRP for In-Vitro Diagnostics
09:00 - 13:00
Contributions

09:00 Overview of PQ IVDs pathways and implementation - Cassiano C. Joao ANARME (Mozambique) Grace Uwanyasagani (Rwanda FDA) Jeniva Rugaiza (WHO) Susie Braniff (WHO)
13:00 Lunch
Lunch
13:00 - 14:30
14:30 PQ GMP inspections
PQ GMP inspections
14:30 - 16:00
Contributions

14:30 Overview of PQ GMP inspections - Lilit Gharzaryan (Armenian Medical Products Regulatory Authority, Armenia) Stephanie Croft (Speaker)
16:00 Afternoon Coffee Break
Afternoon Coffee Break
16:00 - 16:30
16:30 Group Session Outcomes
Group Session Outcomes
16:30 - 17:15
Contributions

16:30 Presentations of Group Session Outcomes - Cassiano C. Joao ANARME (Mozambique) Endo Ayumi (Pharmaceutical and Medical Devices Agency (PMDA), Japan) Grace Uwanyasagani (Rwanda FDA) Jeniva Rugaiza (WHO) Lawrence Nzumbu Natasha Brockwell (TGA) Nyasha Lizzie MAREGERE Sakeni Hadebe (Zambia) Susie Braniff (WHO) Tharnkamol Chanprapaph (Thailand) Victoria Palmi Reig (Netherlands (Kingdom of the)) Yuriko Takemura
17:30 End of the Day 2
End of the Day 2
17:30 - 17:35
Thursday 14 November 2024
09:00 CRP Clinics: One on one Interactions with NRAs
CRP Clinics: One on one Interactions with NRAs
09:00 - 10:30
Contributions

09:00 1 on 1 meetings with registered NRAs (participating and non-participating): discussions, questions, and answers: 10 minutes per NRA - Agnes Sitta Kijo (WHO) Ana Rita GODINHO DA COSTA NOGUEIRA (WHO) Nyasha Lizzie MAREGERE Sunday kisoma (WHO)
10:30 Morning Coffee Break
Morning Coffee Break
10:30 - 11:00
11:00 ePQS
ePQS
11:00 - 11:40
Contributions

11:00 ePQS: new centralized platform for CRP applications - Ana Rita GODINHO DA COSTA NOGUEIRA (WHO)
11:40 Collaborative registration procedures for medical products
Collaborative registration procedures for medical products
11:40 - 12:10
Contributions

11:40 Good practices of national regulatory authorities in implementing the CRP for medical products – Updated guideline - Agnes Sitta Kijo (WHO)
12:10 CRP VCP
CRP VCP
12:10 - 12:30
Contributions

12:10 Update on the CRP VCP Pilot and presentation of the CRP VCP Guideline - Marie Anne Nicole Daniele Valentin (WHO)
12:30 Lunch
Lunch
12:30 - 13:30
13:30 Post Approval Changes
Post Approval Changes
13:30 - 15:00
Contributions

13:30 PAC: Procedure and management - Evelyn Aseawa Paintsil (Food and Drugs Authority, Ghana) Janis Bernat (International Federation of Pharmaceutical Manufacturers and Associations) Nyasha Lizzie MAREGERE RICHARD KASONOGO (Tanzania (United Republic of)) Sunday kisoma (WHO)
15:00 Closing plenary: Meeting summary, recommendations, and way forward (20 min) and Closing remarks (10 min)
Closing plenary: Meeting summary, recommendations, and way forward (20 min) and Closing remarks (10 min)
15:00 - 15:30

15:30 Afternoon Coffee Break
Afternoon Coffee Break
15:30 - 16:00

16:00 End of Day 3
End of Day 3
16:00 - 16:05

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