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

(10 minutes for each intervention)

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...

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...

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

Moderator: Murray Lumpkin, Bill and Melinda Gates Foundation

Presentations (5 min each) and Q&A (15 min)

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...

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)

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)

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...

Meeting summary, recommendations, and way forward

• Principles and methodology of CRP
• CRP statistics: by countries and regions and by CRP stream - SRA CRP and PQ CRP (medicines, vaccines, IVDs)
• Recommendations from CRP 10
• National regulatory authorities’ experiences: numbers and types of products, timelines, experiences, recommended

Q&A and discussions

• 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

• 4 NRAs for medicines and vaccines (2 SRA CRP and 2 PQ CRP), including variations
• 2 NRAs for IVDs (PQ CRP) NRAs

Presentation of max 5 minutes each NRA followed by 15 minutes for Q&A

• 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)