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ICH Update: Emerging Guidelines

Track:
Pharmaceutical Quality

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
317

Room Number:
10

Level:
Intermediate

Type:
Session

Title:
ICH Update: Emerging Guidelines

Chair(s):
Stephen Miller, PhD
CMC Lead, Office of New Drug Quality Assessment, CDER
FDA, United States

Description:
This session will provide an update on the current thinking for safety assessment and control of elemental impurities and mutagenic impurities in pharmaceuticals.

Learning Objective(s):
Identify the current thinking for safety assessment and control of elemental impurities and mutagenic impurities in pharmaceuticals.

Presentation(s) & Speaker(s):
ICH Q3D Update: Looking Ahead to a Globally Harmonized Approach to Elemental Impurities
Mark G. Schweitzer, PhD
Novartis Pharmaceuticals Corporation, United States

ICH M7: Mutagenic Impurities- Safety Considerations
Alisa Vespa, PhD
Assessment Officer
Health Canada, Canada

ICH M7: Mutagenic Impurities - Chemistry, Manufacturing, and Controls Aspects
Stephen Miller, PhD
CMC Lead, Office of New Drug Quality Assessment, CDER
FDA, United States