Christine M. V. Moore, PhD

Organon LLC
Executive Director, Quality Systems & Compliance
Dr. Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, providing oversight for implementation of new GMP-related policy, compendial standards and analytical requirements. Christine started her career as an API process development engineer at Pfizer and Searle/Pharmacia, then moved to US FDA where she led the offices responsible for small molecule new drug review and manufacturing process assessment. In 2016, she returned to industry to advance regulatory policy and innovation at Merck and now Organon. Christine is a global thought leader in scientific and regulatory approaches for advancing pharmaceutical manufacturing technologies including continuous manufacturing, process analytical technologies, and portable/point of care manufacturing. She holds a PhD in chemical engineering from Massachusetts Institute of Technology and a BS in Chemical Engineering from Northwestern University.

Related Articles

Risk Management for Avoidance of Drug Shortages
Features
Risk Management for Avoidance of Drug Shortages

Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual drug shortages.1

Submission and review process diagram
Features
ICH Quality Guidelines: Present Initiatives & ISPE Involvement

In its 30-year history, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has covered a wide range of topics to generate quality, safety, efficacy, and multidisciplinary harmonized guidelines. As science advances, issued guidelines are being updated and new guidelines are proposed in a pipeline of potential future activity. This...