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Session 9, Track 2: Structured Content Implementations across the Drug Development Lifecycle
Session Chair(s)
Theresa Pinnell, MLS
Director of Regulatory Solutions
Kivo, United States
Written content will still be a core requirement of regulatory submissions, labels, and R&D documents. What we do with that content, how it is formatted, reused, repurposed, where it is stored and where it goes; remains critical. The case studies in this session demonstrate two diverse individual roadmaps. Both organizations employ structured content and strong processes to not only achieve regulatory compliance, but to reduce risk, build a framework for flexibility, and manage change.
Preparing the regulatory organization of the future requires alignment of process, preparedness of the organization, readiness of technology, and consideration of data centric approaches. As the industry aligns to data centricity and changing/updated standards committees like FIHR; regulatory teams look for ways to stay flexible.
Learning Objective : - Reduce patient safety and counterfeit risks via digital formats
- Increase regulatory compliance with FDA 21CFR11, EU Falsified Medicines Directive (FMD) and Good Manufacturing Practices (GMP) through an e-labeling initiative
- Prepare for changes and reduce workloads by using structured content to reuse content or re-purpose content
- Assess challenges in continued content management in labelling and benefits of what labeling can provide
Speaker(s)
Unified by Design: Centralizing R&D Document Services to Improve Agility in an Evolving Regulatory Environment
Samantha Lighting, MS
Sanofi, United States
Functional Lead, Submission Ready Documents
Implications of Global Regulatory Momentum Toward Electronic Labeling (e-Labeling) in Pharmaceuticals
Eric Randel, MBA, PMP
Astellas Pharmaceuticals, United States
Associate Director, CCDS & Labeling Lead
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