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Track 1: Clinical Safety and Pharmacovigilance

This track provides an overview of the global regulatory environment in the field of clinical safety and pharmacovigilance for medical products (biopharmaceutical products, advanced therapies, and medical devices), with a focus on pragmatic approaches to protecting patient safety and incorporating the patient voice into the complex and evolving pharmacovigilance ecosystem. Forward-thinking sessions address the application of new technologies and methods to streamline pharmacovigilance systems and processes to enhance protection of patient safety as products become more complex, new data sources drive new analytical techniques, regulatory requirements become more detailed, and medical product development becomes more global.

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