Conveners
Interactive Open to WHO, NRAs, SRAs and Industry - Plenary 1
- Marie Anne Nicole Daniele Valentin (WHO)
Interactive Open to WHO, NRAs, SRAs and Industry - Plenary 2
- Sunday kisoma (WHO)
Interactive Open to WHO, NRAs, SRAs and Industry - PQ GMP inspections
- Sunday kisoma (WHO)
Interactive Open to WHO, NRAs, SRAs and Industry - Group Session Outcomes
- Adrien Inoubli (WHO)
Interactive Open to WHO, NRAs, SRAs and Industry - Post Approval Changes
- Marie Anne Nicole Daniele Valentin (WHO)
Interactive Open to WHO, NRAs, SRAs and Industry - Warm-up exercise for participants in the room: Introduction of participants. Online participants can have a 30-minute coffee break
- Marie Anne Nicole Daniele Valentin (WHO)
Interactive Open to WHO, NRAs, SRAs and Industry - Q&A
- Marie Anne Nicole Daniele Valentin (WHO)
Description
Rapporteur: Nyasha Maregere / Ana Rita Nogueira / Chloe Michelon
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)
12/11/2024, 14:00
- Principles and efficiencies of facilitated regulatory pathways and CRP, and the role of WHO
- WLA and linkages to facilitated regulatory pathways and CRP
Short Interventions/presentations: 10 min for each speaker + 10 min moderator
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)
12/11/2024, 15:40
- Reflections on experience of CRP implementation and added value to regulatory processes.
- Regulatory convergence and harmonization as experienced in CRP implementation
- What works best and areas that require improvements to the procedure
- Proposals/Recommendations for CRP improvement and expansion
- Discussions, Question and Answers
Short Interventions/presentations: 8 minutes...
Lilit Gharzaryan
(Armenian Medical Products Regulatory Authority, Armenia),
Stephanie Croft
(Speaker)
13/11/2024, 14:30
-
Overview of PQ GMP inspections approaches, pathways, and tools (PQ inspections) –
30 minutes -
Q &A and QUIZ/ simulation exercise for NRAs – 40 minutes
-
NRA example and experience – 20 minutes
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
13/11/2024, 16:30
- Group 1 – 15 min
- Group 2 – 15 min
- Q&A – 30 min
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)
14/11/2024, 13:30
- PAC Procedure for PQ CRP: Mx/Vx/IVD (and proposals) – 10 minutes
- PAC Procedure for SRA CRP (and proposals) – 10 minutes
- NRAs experience of PAC management for PQ and SRA CRP – 20 minutes
- Recommendations from Industry (IFPMA) – 20 minutes
- Discussion, Question and Answers – 30 minutes
Presentations followed by examples of NRAs and Q&A
Marie Anne Nicole Daniele Valentin
(WHO)
Overview of Facilitated Regulatory Pathways and Introduction of CRP principles, and high-level implementation of recommendations from 11th Annual CRP meeting (20 min)
Alireza Khadem Brooderji
(WHO, 12th Annual meeting on Collaborative Registration Procedure| TORs | page 11 Short Interventions/presentations: 10 min for each speaker (60min Speakers + 10min moderator) Regulatory Systems Strengthening), Mr
Hiiti Sillo
(WHO, Unit Head of Regulation and Safety),
Jackson Hungu
(UNITAID),
Murray Lumpkin
(Bill and Melinda Gates Foundation ),
Prequalification WHO Unit Head ,
Victoria Palmi
(EMA)
- Principles and efficiencies of facilitated regulatory pathways and CRP, and the role of WHO
- WLA and linkages to facilitated regulatory pathways and CRP
Short Interventions/presentations: 10 min for each speaker (60min Speakers + 10min moderator)
Marie Anne Nicole Daniele Valentin
(WHO)
Overview of the objectives, general introduction of participants, agenda and logistics/housekeeping
Agnes Sitta Kijo
(WHO),
Ana Rita GODINHO DA COSTA NOGUEIRA
(WHO),
Nyasha Lizzie MAREGERE,
Sunday kisoma
(WHO)
- Stream 1: PQ CRP Mx/Vx
- Stream 2: SRA CRP
- Stream 3: PQ CRP IVDs
- Stream 4: PQ CRP/SRA CRP for French Speaking countries
1 on 1 meetings with registered NRAs (participating and non-participating): discussions, questions, and answers: 10 minutes per NRA
Victoria Palmi Reig
(Netherlands (Kingdom of the))
High level panel on Facilitated Regulatory Pathways and CRP
- Principles and efficiencies of facilitated regulatory pathways and CRP, and the role of WHO
- WLA and linkages to facilitated regulatory pathways and CRP
Agnes Sitta Kijo
(WHO),
Ana Rita GODINHO DA COSTA NOGUEIRA
(WHO),
Marie Anne Nicole Daniele Valentin
(WHO),
Nyasha Lizzie MAREGERE,
Sunday kisoma
(WHO)
High level panel on Facilitated Regulatory Pathways and CRP
- Principles and efficiencies of facilitated regulatory pathways and CRP, and the role of WHO
- WLA and linkages to facilitated regulatory pathways and CRP
