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Implementing Changes To Drug-Device Combination Products Globally
Session Chair(s)
Chelsea O'Connell, MS, RAC
Director, Global Regulatory Policy & Intelligence
Amgen, United States
Industry and regulators will collaborate to discuss current challenges and future opportunities to streamline post approval changes to combination products.
Learning Objective : Describe current regulatory frameworks for lifecycle management changes to combination products; Compare differences in expectations for submissions of post-approval changes globally; Discuss the utilization of harmonized guideline, ICH Q12, and associated training materials (Module 8) for management of post approval changes to combination products globally.
Speaker(s)
FDA CBER Perspective on Postmarket Changes to CBER-Led Combination Products
Andrea Gray, PhD
FDA , United States
Biomedical Engineer Advisor, CBER
Industry Perspective on the Latest ICH Q12 Training Module 8
Andrew Chang, PhD
Novo Nordisk, United States
Vice President, Quality and Regulatory Compliance
Industry Perspective on Postmarket Changes to Combination Products: Global
Amy Wise, MBA
AbbVie, United States
Associate Director, RA Device and Combination Products
PMDA Update: Postmarket Changes to Combination Products in Japan
Keisuke Tanaka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer
Industry Perspective on Postmarket Changes to Combination Products: US
Lori-Anne Boville
Genentech, A Member of the Roche Group, United States
Group Director, Pharma Technical Regulatory, Device and Combination Products
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