Cosmetovigilance: Adverse event management and compliance

From regulatory foundations to procedural obligations under EU, UK, and US regulations, with a focus on implementing an effective quality system for managing adverse events and serious undesirable effects.

Abstract

From regulatory foundations to procedural obligations under EU, UK, and US regulations, with a focus on implementing an effective quality system for managing adverse events and serious undesirable effects. The program covers operator responsibilities, case collection and evaluation methods, PIF updates, and staff training, providing practical guidance for accurate reporting and communication with Competent Authorities.

Key Points

  • Regulatory foundations and obligations (EU, UK, USA)

  • Objectives and guidelines

  • PIF updates and safety substantiation (USA)

  • Control tools along the supply chain

  • Reporting and interaction with Competent Authorities

Structure

4-hour course.

Live streaming or on-site at your company, based on your needs.

Would you like to host this course at your company?

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