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.

Highlighted Topics:

• 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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