返回 Agenda
Session 7 Track A: Revision of ICHQ2 and ICHQ14: Analytical Procedure Development
Session Chair(s)
Phil Borman, DrSc
Director Product Development & Supply
GlaxoSmithKline, United Kingdom
This session will provide an overview of the plans to revise ICHQ2 and to develop the new ICHQ14 guideline on Analytical Procedure Development following the creation of the ICHQ2(R2)/ICHQ14 concept paper at the end of 2018. Case studies will be provided which relate to how related enhanced approaches have been used to support Analytical Procedure Development, Validation and lifecycle activities – defined as the Analytical Procedure Lifecycle (Management) by expert working groups in the USP and EFPIA. The linkage between ICHQ12 and ICHQ14 will also be explained.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand why and how ICHQ2 will be revised and ICHQ14 developed
- See how enhanced approaches have been applied to analytical procedures and understand the link with Q14
- Understand the link between ICHQ12 and ICHQ14
Speaker(s)
Introduction to ICH Q2/Q14 Topic. Perspectives for multivariate spectroscopic methods development and validation.
Bogdan Kurtyka, PhD
FDA, United States
Senior Process Quality Assessor
Plans and opportunities for the revision of ICHQ2 inc Biologics aspects
Mary Beth Pelletier
Biogen, United States
Associate Director, Analytical Technology
Case Studies of Application of Concepts Outlined in Proposed USP General Chapter <1220> The Analytical Procedure Lifecycle
Kimber Barnett, PhD
Pfizer, United States
Research Fellow
ICHQ14 concepts under consideration and links with ICHQ12
Phil Borman, DrSc
GlaxoSmithKline, United Kingdom
Director Product Development & Supply