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

Moderator(s)

• CH

  Clarice 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

Presenter(s)

• 

  Kevin O'Donnell, PhD

  Market Compliance Manager
  Health Products Regulatory Authority
  Dublin 2, Dublin, Ireland

  Presentation Handout

Regulatory Panelist(s)

• 

  Mahesh Ramanadham, PharmD, MBA

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

Presentations:

• 11:45 – 12:12 EDT

  Quality Risk Management: An Update on the Ongoing Revision of ICH Q9
  

  Presenter: Kevin J. O'Donnell, PhD – Health Products Regulatory Authority
• 12:12 – 12:42 EDT

  Implementation of ICH Q12
  

  Presenter: Frank Montgomery, PhD – AstraZeneca
• 12:42 – 13:15 EDT

  Live Q&A (B4)
  

  Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer

  Panelist: Frank Montgomery, PhD – AstraZeneca

  Regulatory Panelist: Kevin J. O'Donnell, PhD – Health Products Regulatory Authority

  Regulatory Panelist: Mahesh R. Ramanadham, PharmD, MBA – U.S. FDA