Session: B4: ICH’s Initiatives to Advance Global Harmonization, Innovation, and Continual Improvement Throughout Lifecycle

Live Q&A (B4)

Wednesday, September 29, 2021

12:42 – 13:15 EDT

A brief overview of ICH initiatives with a deeper dive into ICH Q12 Implementation and ICH Q9 revisions. Learn how ICH Q12 implementation can support LCM and continuous improvement, leveraging PQS to support changes post approval. Recent case studies will be presented. ICH Q9 (QRM) revisions may include additional clarity on the concept of formality in QRM to ensure that the extent of scientific and methodological rigor applied is commensurate with the level of risk, enabling better, more informed, and timely decisions in QRM. Evaluation of supply chain risk along with risks to quality is being considered. The guideline will also discuss controlling subjectivity by addressing bias, using appropriate QRM tools and relevant data. An overview of other ICH initiatives will include Q13 Continuous Manufacturing, ICH Q3E Extractables/Leachables, ICH Q2(R)/Q14, ICH M4Q revisions and a newly approved ICH topic, Structured Product Quality Submissions.

Moderator(s)

CH

Clarice H. Hutchens, PhD, MA, DM

Senior Director
Pfizer
Ballwin, Missouri, United States

Panelist(s)

Frank Montgomery, PhD

Global Head, Regulatory CMC
AstraZeneca
Macclesfield, England, United Kingdom

Regulatory Panelist(s)

Kevin J. O'Donnell, PhD

Market Compliance Manager
Health Products Regulatory Authority
Dublin 2, Dublin, Ireland
Mahesh R. Ramanadham, PharmD, MBA

Associate Director Scientific Operations, CDER
U.S. FDA
Highland, Maryland, United States