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