ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision

Learning Level: Intermediate
Session Length: 3.5 hours

Are you ready to implement the updated ICH Q9?

Global regulators including members of the ICH Q9(R1) Expert Working Group will participate in discussions on the background, issues, and status of the ICH Q9 revision and provide perspectives on the current state of application of quality risk management in industry. Discussion panels and breakouts will address practical implementation of the key focus areas of the ICH Q9 Revision: Subjectivity, Product Availability, Formality, Decision-making, Digitization and New Technology/Modalities. Attendees will be able to provide their thoughts to regulators on the training needed to implement the updated ICH Q9.

First-hand Strategic Insights & Actionable Takeaways 

  1. Understand the key focus areas of the updated ICH Q9 and discuss strategies for their practical implementation.
  2. Understand the continuum of risk assessment from informal to formal.
  3. Increase the understanding and consistent application of QRM.
  4. Learn how the revised ICH Q9 guideline can help improve communication with regulators during inspections and during management of deviations, root cause analysis, change management and CAPA.
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies
Problem-Solving
Problem-Solving

Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!

ISPE Expert Xchange Session Speakers & Panelists

Alice Redmond, PhD
Chief Strategy Officer
CAI
Leader
John G. Groskoph
Executive Director, Global CMC
Pfizer
Leader
Jean Francois Duliere
Reg Advisor
ISPE
Moderator
Jane Lavinia Duncan
AstraZeneca
Moderator
Rick Friedman
Deputy Director, Office of Manufacturing Quality
FDA/CDER
Panelist
Mette Kraemmer HANSEN
Compliance and QRM Specialist
Fujifilm
Moderator
Diane L. Hustead
Executive Director, Regulatory Affairs
Merck & Co., Inc.
Moderator
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Moderator
Christine M. V. Moore, PhD
Executive Director, Quality Systems & Compliance
Organon LLC
Speaker
Jacques Morenas
Technical Advisor of the Inspection Division Director
ANSM
Panelist
Kevin O'Donnell, PhD
Market Compliance Manager
Health Products Regulatory Authority (HPRA)
Speaker
Rosemary Orciari
Director Quality Operations
Pfizer, Inc.
Moderator
Christopher John Potter, PhD
CMC Pharmaceutical Consultant
Moderator
Felipe Augusto Gomes Sales
Health Regulation and Surveillance Specialist
Brazilian Health Regulatory Agency - ANVISA
Panelist
Timothy J.N. Watson, PhD
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences
Panelist
ISPE Expert Xchange Rates

ON DEMAND ACCESS FOR 90 DAYS

Member $199
Nonmember   $249 

Buy On Demand

ISPE Membership Benefits

Become a member today

Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.

Benefits include:

  • Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
  • Member-only discounts on Guidance Documents, Conferences, and Training
  • Pharmaceutical Engineering® magazine
  • Communities of Practice access to pharma professionals in specific topics from around the world
  • And more
Join Today