SafetyCall On What Cosmetics Companies Need In Their AE Reporting Systems

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.

Speaking at the Independent Beauty Association’s FDA Cosmetics Regulation Workshop on 21 September, Kingston – whose company specializes in AE management and regulatory compliance services – identified key components of the system industry stakeholders need to develop to comply