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SafetyCall On What Cosmetics Companies Need In Their AE Reporting Systems

 
• By Eileen Francis

Companies preparing for adverse event reporting and recordkeeping deadlines on 29 December under new cosmetics regulations should ensure they have systems in place for netting complaints across media, triaging reports, and making speedy weight-of-evidence determinations, said SafetyCall International’s Rick Kingston at IBA’s recent FDA regulatory workshop.

Warning Signal

A proper system for meeting adverse event reporting (AER) and recordkeeping requirements under the Modernization of Cosmetics Regulations Act should comprise a database for capturing all reports and post-market surveillance that includes signal detection, triaging, and weight-of-evidence decision making, according to Rick Kingston, co-founder and president of regulatory and scientific affairs at SafetyCall International, LLC.

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More from Policy & Regulation

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