This track provides an overview of the evolving global regulatory environment in clinical safety, pharmacovigilance, and risk management for medical products, including biopharmaceuticals, advanced therapies, and medical devices. Sessions focus on proactively identifying, assessing, and mitigating risks to protect patient safety, while incorporating the patient voice into the pharmacovigilance ecosystem. Forward-thinking discussions explore the application of new technologies, real-world data sources, and advanced analytical techniques to enhance safety signal detection, strengthen benefit-risk assessment and communication, and optimize risk management planning and execution across the product lifecycle as regulatory requirements evolve and medical product development becomes increasingly global.

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