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

→ 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.

Final_Agenda.pdf
SM code-of-conduct WHO Events[96].pdf
Instructions for participants
Presentations
Contact:
Surveys
Gentle Reminder : 11th CRP Annual Meeting Survey
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  • 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 )
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