ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision

Learning Level: Intermediate
Session Length: 3 1/2 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!


Agenda


ISPE Expert Xchange Session Speakers & Panelists

Alice Redmond, PhD
Chief Strategy Officer
CAI
Moderator
John G. Groskoph
Executive Director, Global CMC
Pfizer
Moderator
Rick Friedman
Deputy Director, Office of Manufacturing Quality
CDER/FDA
Christine M. V. Moore, Ph.D.
Executive Director, External Advocacy & Policy
Organon
Jacques Morenas
Technical Advisor of the Inspection Division Director
ANSM
Placeholder Person Graphic
Kevin O’Donnell
Market Compliance Manager
HPRA
Speaker
Timothy J.N. Watson, PhD
Executive Director & Team Leader, CMC Advisory Office
Pfizer Inc

ISPE Expert Xchange Rates

ON DEMAND ACCESS FOR 90 DAYS

Member $199
Nonmember   $249 
Academia/Emerging Economy/Government*  $120
Recent Graduate*  $75
Student* $75

Register

*ISPE Membership is required for these rates.

Group Discount Rate

Bring your team to the ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision

  • 3 - 5 participants - Save 10%
  • 6 or more participants - Save 15%

Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


Receive ISPE Expert Xchange Notifications

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   

Stay up-to-date on registration, expert Xchange opportunities, and more by signing up to receive notifications.

Name
Company Type