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

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

11 Dec 2023, 08:00 → 13 Dec 2023, 15:00 Asia/Qatar

Hybrid

Hilton Hotel Doha, Doha, Qatar

Hilton Hotel Doha

Monday 11 Dec to 13 December OPEN SESSIONS https://who.zoom.us/s/93271234851 Password: 11CRP2023!

Agnes Kijo (WHO, FPI)

Description

The Annual Meeting on the Collaborative Registration Procedure (CRP) is organized to support accelerated national registration of prequalified medicines, vaccines, in-vitro diagnostics (IVDs), and products approved by the "Stringent Regulatory Authorities (SRA)”.

Essentially, the accelerated registration for WHO-prequalified products and SRA-approved medicines in participating countries is through the reliance on shared confidential assessment or inspection reports with regulatory focal points at the manufacturers' request.

The 11th Annual CRP Meeting will be held in Doha, Qatar between 11-13 December 2023. The venue for the meeting is the Hilton Hotel Doha, located in the West Bay diplomatic area, on the north end of the Doha Corniche.

Keep an eye out for updates and additional information regarding this important event.

Contact:

zaoualim@who.int

Surveys

Gentle Reminder : 11th CRP Annual Meeting Survey

Monday 11 December
- Open sessions to WHO, NRAs, SRAs, Industry and Partners: Morning Session
  Hybrid
  
  Convener: Hiiti Sillo (WHO Unit Head, Regulation and Safety, MODERATOR)
  - 1
    
    Arrival of participants and Registration to CRP Annual Meeting
    Hybrid
    
    Speaker: All
  - 2
    
    Opening session - keynote address
    Hybrid
    
    https://who.zoom.us/s/93271234851
    
    (10 minutes for each intervention)
    
    Speakers: Hiiti Sillo (Team Lead, WHO Regulation and Safety ), Rayana Ahmad Bou Haka (WHO Representative of Qatar )
  - 3
    
    Introduction of participants
    Hybrid
    
    Speaker: Marie Valentin (WHO, Team Lead, Facilitated Product Introduction Team)
  - 4
    
    Overview of the objectives, agenda and logistics/housekeeping
    Hybrid
    
    Speaker: Marie Valentin (WHO, Team Lead, Facilitated Product Introduction)
  - 5
    Plenary 1: High level panel on Facilitated Regulatory Pathways
    Hybrid
    
    Moderator: Hiiti Sillo, WHO Regulation and Safety
    
    Principles of facilitated regulatory pathways
    
    Existing facilitated regulatory pathways: characteristics and documented efficiencies
    
    Role of WHO and regional economic communities (RECs)
    
    Good Reliance Practices: main principles and linkages to facilitated regulatory pathways
    
    Regulatory reliance and Global Benchmarking Tool (GBT)
    
    Risk based approach to regulatory systems
    
    Speakers: 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 )
  - 11:00
    
    Group Photo and Coffee Break
    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
  - 6
    Plenary 2: Facilitating national medical products registration through Collaborative Registration Procedure (CRP)
    Hybrid
    
    Moderator: Victoria Palmi, EMA
    
    Principles and methodology of CRP
    
    CRP statistics: by countries and regions and by CRP stream - SRA CRP and PQ CRP (medicines, vaccines, IVDs)
    
    National regulatory authorities’ experiences: numbers and types of products, timelines, experiences, recommendations
    
    Short presentations/interventions from each of the speaker (5 minutes max) followed by Q&A and discussion
    
    Speakers: 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 )
  - 13:00
    
    Lunch
    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
- Open sessions to WHO, NRAs, SRAs, Industry and Partners: Afternoon Session
  Hybrid
  - 7
    Plenary 3: Perspectives from the Partners, RECs and SRA
    
    Moderator: Hiiti Sillo, WHO Unit Head Regulation and Safety
    
    Reflections on regulatory reliance and position of CRP in facilitating access to quality assured medical products
    
    What works best and what could be improved?
    
    Available and foreseen commitments to WHO and Member States
    
    Short presentations/interventions from each of the speaker (10 minutes max) followed by Q&A and discussions
    
    Speakers: 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)
  - 15:30
    
    Coffee Break
  - 8
    
    Workshop 1: Experience sharing from Industry and recommendations
    
    Moderator: Murray Lumpkin, Bill and Melinda Gates Foundation
    
    Presentations (5 min each) and Q&A (15 min)
    
    Speakers: 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)
  - 17:30
    
    Free Time
  - 18:30
    
    Reception
Tuesday 12 December
- Open sessions to WHO, NRAs, SRAs, Industry and Partners
  Hybrid
  
  Convener: Marie Valentin (WHO, Team Lead Facilitated Product Introduction, MODERATOR)
  - 9
    Workshop 2: Interactive sessions in groups
    
    Facilitator: Sunday Kisoma, WHO FPI
    Moderator: Amélie Darmon, Global Fund
    
    Please Note: 09:00 – 10:30 - For face-to-face participants
    Participants online can join from 10 am 
    
    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
    
    Group discussion (4 groups) 45 minutes, presentations from the 4 groups 10 minutes each including Q&A (45 minutes)
    
    Speaker: All
  - 10:30
    
    Coffee Break
  - 10
    
    Workshop 3: WHO Prequalification
    
    Moderator: Jackson Hungu, UNITAID
    
    How PQ assessment is performed (product assessment, Site inspections and product testing)
    - Format and content of shared assessment reports
    - Guidelines/standards used for product assessment
    - Post prequalification activities and implications on CRP products
    
    Presentations (25 minutes each) followed by Q&A (20 minutes)
    
    Speakers: Lawrence Nzumbu, (WHO Prequalification, Medicines), Olivier Lapujade (WHO Prequalification, Vaccines), Stephanie Croft (WHO Prequalification, Inspections), Susie Braniff ( WHO Prequalification, In vitro diagnostics)
  - 13:00
    
    Lunch
  - 11
    
    Workshop 4: Overview of SRA approaches and pathways in the assessments of medical products
    
    Moderator: Sergio Cavalheiro Filho, International Federation of Pharma Manufacturers & Asso
    
    Presentations (15 minutes each for Swissmedic and TGA) and practical illustration (20 minutes for EMA) followed by Q&A (10 minutes)
    
    Speakers: Karen Loft (Therapeutic Goods Administration ), Victoria Palmi (European Medicines Agency (EMA) )
- Closed Session to NRAs only
  Hybrid
  
  Moderators:
  Marie Valentin, Team Lead, WHO FPI (Day 2)
  Ann Ottosen, United Nations Children`s Fund (Day 3)
  
  Convener: Marie Valentin
  - 12
    
    Plenary 4: Practical examples of NRA’s good practices for implementation of CRP and recommendations
    
    Moderator: Phillipe Doo-Kingue, WHO Regional Office for Africa, AFRO
    
    Presentation of max 5 minutes each NRA followed by 15 minutes for Q&A
    
    Speakers: 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)
  - 15:45
    
    Coffee Break
  - 13
    Workshop 5: Application of reliance-based approaches in GMP Inspections and site Quality Audits
    
    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 requirements (20), followed by Q&A (10 minutes)
Wednesday 13 December
- Closed Session to NRAs only
  Hybrid
  
  Moderators:
  Marie Valentin, Team Lead, WHO FPI (Day 2)
  Ann Ottosen, United Nations Children`s Fund (Day 3)
  - 14
    The Collaborative Registration Procedure in practice – 2023 perspectives
    
    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
  - 15
    
    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
    
    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)
    
    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 session
    Feedback and Discussion in Plenary
- 11:00
  
  Coffee Break
  Hybrid
  
  Monday 11 Dec to 13 December OPEN SESSIONS https://who.zoom.us/s/93271234851 Password: 11CRP2023!
- Open sessions to WHO, NRAs, SRAs, Industry and Partners
  Hybrid
  - 17
    Tools to support implementation of CRP including the Electronic Prequalification System
    
    Facilitators: Nyasha Maregere , Consultant, WHO Facilitated Product Introduction Team
    Sunday Kisoma, Consultant, WHO Facilitated Product Introduction Team
    Ana Rita Nogueira, Consultant, WHO Facilitated Product Introduction Team
    
    CRP guidelines
    
    Templates for screening, verification, abridged assessment
    
    Electronic Prequalification System
    
    Presentation of 45 minutes, 15 minutes for all interventions
- 12:30
  
  Lunch
  Hybrid
  
  Monday 11 Dec to 13 December OPEN SESSIONS https://who.zoom.us/s/93271234851 Password: 11CRP2023!
- Open sessions to WHO, NRAs, SRAs, Industry and Partners
  Hybrid
  - 18
    
    Closing plenary
    
    Meeting summary, recommendations, and way forward
    
    Speaker: Marie Valentin (WHO Team Lead Facilitated Product Introduction )
  - 19
    
    Closing Remarks
    
    Speaker: Marie Valentin (WHO Team Lead Facilitated Product Introduction )