
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.
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