12th Annual Meeting on Collaborative Registration Procedure (CRP): Reliance through Facilitated Product Introduction

Recorded Video

Objectives, agenda, logistics/housekeeping, PSEAH

Overview of Facilitated Regulatory Pathways and Introduction of CRP principles, and high-level implementation of recommendations from 11th Annual CRP meeting

• Progress, achievements, and way forward
• Additional information on Recommendations from 11th Annual CRP meeting for product specific streams

• Progress, achievements, and way forward
• Additional information on Recommendations from 11th Annual CRP meeting for product specific streams

• Progress, achievements, and way forward
• Additional information on Recommendations from 11th Annual CRP meeting for product specific streams

• 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

• 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 for each speaker and 10 minutes for question and answers

• Overview of SRA review process for MAAs and PACs, reliance policies and practices – EMA (20 minutes)

• Overview of SRA review process, reliance policies and practices – TGA (20 minutes)

• Overview of SRA review processes, reliance policies and practices – PMDA (20 minutes)

• Overview of WHO/PQT review processes, reliance policies and practices – WHO/PQT (30 minutes)

• Question and Answers (10 minutes)

• Tools to facilitate implementation of CRP by NRAs – WHO/FPI (20 minutes)

• NRA experience, best practices, procedures, and tools for CRP implementation – Thailand (30 minutes)

• NRA experience, best practices, procedures, and tools for CRP implementation – Zambia (30 minutes)

• Question and Answers (10 minutes)

• Introduction to the session: Moderator (10 minutes)

• Overview of PQ IVD approaches, pathways, and tools in the assessments of products and resources (60 minutes)

• Overview of tools to support CRP implementation – CRP steps, guidelines, and templates available for Product dossier verification and Abridged assessments and verification of sameness (online system, shared point, other reference documents) (60 minutes)

• NRA product verification and abridged assessment application processing and product dossier verification and Abridged assessments – (90 minutes, 45 minutes each)

• Q & A and recommendations – All (20 minutes)

• 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

1. Group 1 – 15 min
2. Group 2 – 15 min
3. Q&A – 30 min

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

• Interface outlook and functions for NRAs and Applicants – 10 minutes
• Instructions for stakeholders' registration in the platform – 10 minutes
• Discussion, Question and Answers – 20 minutes

• Presentation on updated guideline - 20 minutes
• Discussion, Question and Answers - 10 minutes

• Presentation on updated guideline - 15 minutes
• Discussion, Question and Answers - 5 minutes

• 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