WHO PQ Workshop

GBC 11

WHO PQ Workshop

09:00 ~ 13:00 Chrysanthemum 2F

Summary
WHO PQ is required to secure competitiveness in the global pharmaceutical market. The WHO PQ Team will provide specific information including its criteria, which have been expanded to biosimilars.
Date
June 27(Wed), 09:00 ~ 13:00
Venue
Chrysanthemum 2F Venue Guide

Schedule

Time Title Presentation File
WHO PQ
WHO PQ Seminar
09:00~09:15(15')

PQ Overview

Carmen Amelia Rodriguez / WHO

09:15~09:35(20')

Vaccine Prequalification Overview

Carmen Amelia Rodriguez / WHO

09:35~10:15(40')

PQ Pilot Process for Prequalification of Biosimilars

Drew Meek / WHO

10:15~10:30(15')

New dossier format- CTD to replace PSF

Drew Meek / WHO

10:30~10:50(20')

Coffee Break

-
10:50~11:10(20')

The PQ process: Quality assessment and Programmatic suitability for Prequalification

Drew Meek / WHO

11:10~11:30(20')

The PQ process: GMP Inspection

Mustapha Chafai / WHO

11:30~11:55(25')

Clinical Assessment

Olivier Christian Lapujade / WHO

11:55~12:15(20')

Post-Prequalification Monitoring of Prequalifed Vaccines

Carmen Amelia Rodriguez / WHO

12:15~12:30(15')

Discussion and Q&A

Carmen Amelia Rodriguez / WHO

-