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Monday, June 24 • 2:15pm - 3:15pm
#151: Update on ICH Quality Topics

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-551-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide updates on ICH’s efforts to develop new and revised globally harmonized guidelines related to product quality and regulatory CMC topics. Topics include Lifecycle Management, Continuous Manufacturing, and Analytical Methods.

Learning Objectives

Identify the technical and regulatory issues under discussion in ICH as they related to regulatory CMC and product quality topics; Discuss various perspectives from the expanded ICH membership on the impact, opportunities and challenges for the new and ongoing ICH Quality Topics.

Chair

Olivia Shopshear, MS

Speaker

ICH Quality Vision and Context Setting
Camille Jackson

M9 and IQDG
Roger Nosal, PhD

Q2(R2) - Analytical Procedure Validation / Q14 - Analytical Procedure Development
Nasir Egal, PhD

Q12
Sarah Pope Miksinski, PhD

Q13
Ganapathy Mohan, PhD



Speakers
CJ

Camille Jackson

Associate Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Camille Jackson is currently Associate Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she manages PhRMA’s international regulatory policy initiatives including engagement in the International Council for Harmonization (ICH) and the APEC Regulatory Harmonization... Read More →
avatar for Nasir Egal

Nasir Egal

Head of Global Quality External Affairs, Sanofi
Nasir EGAL currently leads the Sanofi Global Quality External Affairs strategy. Prior to this role, he held various positions of increasing responsibilities in Sanofi, Novartis & Merck. He has a broad international experience working across various cultures and geographies leading... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Senior Director, AstraZeneca
avatar for Ganapathy Mohan

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc.
Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Global CMC, Pfizer Inc
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 PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Olivia Shopshear

Olivia Shopshear

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Olivia is a senior director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA