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

• 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)

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• 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...

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

• Overview of tools to support CRP implementation – CRP steps, guidelines and tools, Product dossier verification and Abridged assessments (FPI) - 20 min
• 2 NRA practical examples of CRP application processing and product dossier verification and Abridged assessments – 60 min
• Q&A and QIZ/simulation exercise for NRAs – 40 min
• Recommendations on way forward and compilation of outcomes...