Name: Panel Discussion: Are Clinical Teams Prepared For ICH E6 (R3)?
Start: 2023-03-28T12:35:00-0400
End: 2023-03-28T13:25:00-0400

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Panel Discussion: Are Clinical Teams Prepared For ICH E6 (R3)?

Discover New Trends, Past Experiences, And How Clinical Team Members Are Keeping Up With Updates to ICH E6 (R3) Regulatory Requirements

Hear learnings from implementation of QTLs
Discuss possible future expectations with the upcoming ICH E6 revision

This Interactive Panel Discussion Will Also Answer Questions Like:

Why is ICH E6 being revised again if it was just updated?
Requirements aside, what value is there in QTLs?
Will QTLs merge or get replaced with another clinical metric term?
What is the future of measurement of quality in clinical trials?

Speakers

Lina Kim

Former Director, Clinical Quality Assurance/ Independent Consultant, PURETECH HEALTH

Experienced Senior Director with a demonstrated history in the pharmaceutical industry. Skilled in Quality Management (GCP, GMP), Manufacturing, Strategy/Strategic Initiatives, and Lean Six Sigma. My educational background includes a Bachelor of Chemical Engineering from Villanova... Read More →

Joanne Hutchinson

Associate Director, Quality Planning & Strategy, JOHNSON & JOHNSON

Kristin Stallcup

Director, Risk Based Quality Management Operations, TAKEDA

Leads a team of Risk Based Quality Management (RBQM) Coordinators to support study teams with implementing RBQM methodology at the study level, including initial and recurring risk identification, assessment, and mitigation activities within the RBQM framework.