2026 Fall AC - Preparing for ICH M16 Structured Product Quality Submissions

Preparing for ICH M16 Structured Product Quality Submissions Presented by: Rita Algorri, PhD, Associate Director, Global Regulatory Affairs (Amgen) Sheetal Gaiki, Sr. Principal Scientist II at (Johnson & Johnson) ICH M16 is being developed to define a harmonized approach for Structured Product Quality Submissions (SPQS), supporting a transition from document-based CMC submissions toward structured, machine-readable product-quality information. This transition is expected to impact how companies create, reuse, and exchange CMC content. This session will provide an overview of the guideline’s objectives, scope, and relationship to ICH M4Q(R2). The policy and operational implications of structured CMC information, including its potential effects on submission preparation, regulatory assessment, management of post-approval changes, and interoperability across company and regulatory systems will be discussed. Companies can begin planning for structured data exchange by identifying where authoritative CMC data reside, establishing data ownership and governance, standardizing internal terminology and identifiers, and improving traceability between source data and submission content. The session will distinguish actions companies can take now from decisions that depend on further ICH development and regional implementation. Rita Algorri, PhD is an Associate Director, Global Regulatory Affairs at Amgen Inc. in Thousand Oaks, CA. In this role, her responsibilities include leading initiatives on regulatory modernization, digitization, AI, automation, and emerging technologies. Rita also serves within Amgen’s Advocacy and External Engagement function which fosters collaboration with multiple internal and external cross-functional teams. She is a member of the ICH EWG for ICH M16 Structured Product Quality Submissions. Rita is a microbiologist by training and holds a PhD in Clinical and Experimental Therapeutics and M.S. in Regulatory Science from the University of Southern California School of Pharmacy. Sheetal Gaiki is a Sr. Principal Scientist II at Johnson & Johnson with over 20 years of experience across biologics, combination products, small-molecule development, and regulatory dossiers. She leads CMC and Regulatory digitalization initiatives focused on data standards and governance, GenAI, structured content, and technology solutions. Sheetal is a member of the ICH M16 Expert Working Group (SPQS) and co-leads the HL7 BR&R Pharmaceutical Quality Information (PQI) FHIR project. Her work takes an end-to-end view of the data lifecycle, from generation through consumption, aligning technology with regulatory expectations, business processes, and change management.