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2025年8月06日 (水) 午後 12:00 - 2025年8月06日 (水) 午後 1:00

(US Eastern Standard Time)

DIA Direct: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products

Navigate the complexities of global post-approval changes with strategies that prioritize speed, compliance, and patient safety.

概要

Join DIA’s Direct Community Webinar hosted by DIA's Regulatory Affair Community

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally. The pharmaceutical industry needs a harmonized approach to establish globally recognized standards for change management, streamline regulatory pathways, foster transparency and collaboration, and prioritize patient safety and product quality throughout the process.

特集トピック

    • Strategies for Harmonizing Global Post-Approval Change Management
    • Enhancing Regulatory Transparency and Collaboration to Safeguard Patient Safety

参加対象

The webinar is designed for regulatory affairs professionals, CMC (Chemistry, Manufacturing, and Controls) experts, quality assurance leaders, and global supply chain managers

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