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Monday, June 28 • 2:30pm - 3:30pm
#138 SL: Advancing ICH Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Amanda Marie Roache, MS

Speaker

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

ICH Quality Discussion Group and the Future of Quality Guidelines
Roger Nosal, PhD

Q13 Continuous Manufacturing to Improve Efficiency, Agility, and Flexibility of Pharmaceutical Manufacturing
Wendy Zwolenski-Lambert, MSc


Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →
RF

Rick Friedman

Deputy Director, OMQ, Office of Compliance, CDER, FDA, United States
Richard L. Friedman is Deputy Director, Office of Manufacturing and Product Quality, in the compliance office in FDA/CDER. This position includes review of regulatory actions and policy development. Prior to joining FDA in 1990, he worked in toxicology research at Parke-Davis. Mr... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Wendy Zwolenski-Lambert

Wendy Zwolenski-Lambert

Director, Regulatory Affairs CMC Strategy and Policy, Novartis Pharma AG, Switzerland
Wendy Zwolenski-Lambert Wendy Zwolenski-Lambert is the Efpia topic lead on the ICH Q13 Continuous Manufacturing Expert Working Group. Following a decade working in medical devices and drug delivery systems, she moved to biopharmaceutical manufacturing of monoclonal antibodies. She... Read More →

Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Forum
  • Beginner Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking
  • Featured Topics Regulator Thinking
  • Tags Forum