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Track 1: Clinical Safety and Pharmacovigilance

DIA 2017: Driving Insights to Action

This track, with the overarching theme, Big Data – How to Address and Relevance, has sessions providing an overview of the global regulatory environment in the field of clinical safety and pharmacovigilance for medical products (biopharmaceutical products 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.

Sessions in Clinical Safety and Pharmacovigilance

Sunday, June 23 | Short Courses

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Monday, June 24

Tuesday, June 25

Wednesday, June 26

Take a look at our video interview from DIA 2018 as Howard Chazin, Director of Clinical Safety Surveillance Staff in the Office of Generic Drugs, CDER, who chaired the session, "Generic Drug Products: Comparison of Safety Profile with Branded Cousin," explains how FDA interprets regulation and safety reporting requirements for generic drugs.

Who is This Track Designed For?

Professionals involved in: drug safety/pharmacovigilance, medical product safety risk assessment, pharmacoepidemiology (including real world evidence generation), post-market studies (including Large Simple Safety Studies and pragmatic safety studies), statistics, benefit-risk assessment and management, benefit-risk communication (including professional and consumer medical product safety labeling), regulatory affairs, clinical research (including clinical trial design), medical affairs, and health outcomes.

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