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Overview of CRP pathways and implementation

13 Nov 2024, 09:00
4h
Hybrid
JS Luwansa Hotel, Jakarta City, Indonesia

JS Luwansa Hotel

Speakers

Ayumi Endo (Pharmaceuticals and Medical Devices Agency, Japan) Lawrence Nzumbu Natasha Brockwell (TGA) Nyasha Lizzie MAREGERE Sakeni Hadebe (Zambia) Tharnkamol Chanprapaph (Thailand) Victoria Palmi Reig (Netherlands (Kingdom of the)) Yuriko Takemura

Description

  • 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)

Presentation materials