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Wednesday, June 26 • 10:30am - 11:30am
#343: Efficient Preparation of Global CMC Dossiers

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-676-L04-P; CME 1.00; IACET 1.00; RN 1.00

Preparation and maintenance of dossiers for a global market is exceedingly complex, due to different expectations for regulatory agencies across the globe. Efficiently creating a dossier to effectively meet worldwide requirements requires careful planning. This session will provide some practical and pragmatic approaches for managing the complexity of global CMC dossiers.

Learning Objectives

Describe the key regulatory considerations for preparation of a global CMC dossier; Discuss some of the global harmonization efforts that are underway.


John Smart, PhD


Global CMC Dossiers: Preparation is Key
Angela McGillivary, PhD

Regulatory CMC Roadmaps for Fast-Evolving Global Markets (Brazil, China, India, Russia and Turkey)
Monika Jain, PhD

avatar for Monika Jain

Monika Jain

Manager , Regulatory Affairs CMC, Regulatory Development Solutions, PPD
Monika Jain, Ph.D. joined the pharmaceutical industry in 1996. She is an internationally accomplished regulatory Chemistry, Manufacturing and Controls (CMC) scientist, with a long- standing background in pharmaceutical research and development of small molecule drug products.Since... Read More →
avatar for Angela McGillivary

Angela McGillivary

Principal Consultant, PAREXEL
Angela is a Principal Consultant at PAREXEL and is an Emerging Markets Regulatory Affairs Professional with over 20 years’ experience in the Pharmaceutical Industry. Angela McGillivary PAREXEL, Principal Consultant Angela has worked with global cross functional teams to develop... Read More →
avatar for John Smart

John Smart

Senior Director and Group Manager, Regulatory CMC, AstraZeneca
John has a PhD in Chemistry and over 20 years’ experience of CMC development within AstraZeneca including roles in Analytical & Product Development and Project Management. John is currently a Senior Director in Regulatory CMC with responsibility for regulatory submissions from Phase... Read More →

Wednesday June 26, 2019 10:30am - 11:30am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA