Global review of Adverse events (AEs) to marketed products: Handling, reporting and monitoring AEs
A past presentation by Viny Srinivasan from last year's 2017 Cosmetic Compliance.
• Roles and responsibilities, collaborating and communicating with Consumer Affairs/Customer Service
• Performing data reconciliation and conducting causality assessments of the AEs
• Signal detection and confirmation as well as monitoring of the trends
• Ensuring timely reporting to regulatory authorities (Mandatory versus Voluntary), for example, in key countries/regions like US, Brazil, China and Europe
• Providing updates to senior management and recommendations for product reformulations
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