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Thursday, June 18 • 9:30am - 10:30am
#414 SL: ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-708-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of ICH quality topics instrumental to the harmonization of pharmaceutical development and manufacturing standards and an introduction to the new and revised topics that are currently underway.

Learning Objectives

Discuss the role of ICH quality topics in harmonizing standards for more efficient pharmaceutical development and manufacturing; Explain current ICH guidelines being revised, new guidelines being developed, and their anticipated impact to pharmaceutical development and manufacture.


Amanda Marie Roache, MS


ICH Strategy to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
Ashley Boam, MS

Industry Perspective on ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Produce Lifecycle Management
Andrew Chang, PhD

Q2(R2)/Q14 Analytical Procedure Development and Validation
Nina S. Cauchon, PhD, RAC

Q13 Continuous Manufacturing
Sau L Lee, PhD

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 international regulatory policy, advocacy in... Read More →
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk Inc., United States
Dr. Chang has more than 20 years of experience in the development, regulation and quality of biologics and pharmaceuticals. As Vice President, Quality and Regulatory Compliance, Novo Nordisk, he is responsible for external affairs, providing strategic advice and solutions for quality... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
avatar for Sau Lee

Sau Lee

Director, Office of Testing and Research, OPQ, CDER, FDA
Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS). He is a Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), and the chair of the OPQ Emerging Technology Team. He is leading the effort in advancing OPQ research and... Read More →
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... Read More →

Thursday June 18, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session