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DIA 2021 Global Annual Meeting


Advancing ICH Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches

Session Chair(s)

Amanda Marie Roache, MS

Amanda Marie Roache, MS

  • Senior Director, Science and Regulatory Advocacy
  • Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Global leaders will convene to discuss the latest developments in the progression of harmonized ICH guidelines for pharmaceutical quality. This session will highlight the significance of guidelines currently under development and discuss considerations for their implementation. There will also be an opportunity for the audience to ask questions and engage with the original authors of these important guidelines.
Learning Objective : Describe the role of ICH quality guidelines in creating efficiency and allowing for the implementation of modern technologies, increased patient access, and fewer disruptions to manufacturing; Discuss ICH guidelines recently issued for public consultation and their anticipated impact; Discuss ICH’s multi-year strategy for modernization of ICH quality guidelines and what topic areas will be important for harmonization in the future.

Speaker(s)

Rick  Friedman, MSc

Q9(R1) Revision of ICH Quality Risk Management Framework to Support More Proactive Approach to Continual Improvement

Rick Friedman, MSc

  • Deputy Director, OMQ, Office of Compliance, CDER
  • FDA, United States
Roger  Nosal, PhD

ICH Quality Discussion Group and the Future of Quality Guidelines

Roger Nosal, PhD

  • Vice President, Head of Global CMC
  • Pfizer Inc, United States
Wendy  Zwolenski-Lambert, MSc

Q13 Continuous Manufacturing to Improve Efficiency, Agility, and Flexibility of Pharmaceutical Manufacturing

Wendy Zwolenski-Lambert, MSc

  • Director, Regulatory Affairs CMC Strategy and Policy
  • Novartis Pharma AG, Switzerland