Cosmetovigilance Training Course

Course overview

The regulations for cosmetic products worldwide have been in place for nearly 50 years and continue to evolve and expand across different regions. Historically, cosmetics were not required to undergo testing in the same way as medicinal products, largely due to the perceived minimal effect or ‘risk’ to the consumer. The same was true for safety reporting.

Over time, this position has changed significantly. The identification and analysis of adverse reactions, known as Serious Undesirable Effects (SUEs), associated with cosmetic products was once largely driven by industry initiatives. Today, however, the responsibility sits firmly with manufacturers to ensure products and ingredients are safe before they reach the market. In addition, they must actively collect and assess reports of undesirable effects in a manner similar to routine pharmacovigilance within the pharmaceutical sector, as well as produce safety summaries for their products.

Regulatory expectations also vary internationally, with different requirements across countries for areas such as the collation of data within the Product Information File (PIF), safety reviews, causality assessments, reporting obligations, and other legislative considerations.

This course delivers a comprehensive overview of Cosmetovigilance across Europe, the USA, and the Rest of the World (ROW). It explores the relevant legislation, regulatory requirements, reporting obligations, the role of the Responsible Person, as well as borderline products and promotional claims.

Overall, the course provides essential guidance for manufacturers and distributors seeking to understand and comply with global regulatory requirements. It is also highly valuable for pharmaceutical and medical device companies looking to expand into the cosmetic market.

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Benefits of attending

• Hear the differences in global regulatory requirements across regions
• Understand causality assessments within Cosmetovigilance and how they are applied
• Learn how to manage the Product Information File (PIF) effectively and in line with regulations
• Gain insight into safety signal analysis and its importance in product safety monitoring
• Understand the role and responsibilities of the Responsible Person in Cosmetovigilance compliance
• Discuss borderline products and how they are classified as cosmetics
• Become aware of advertising and promotional regulations for cosmetic products
• Learn about the sanctions that Regulatory Agencies can impose with non-compliance

Who should attend

• Customer call personnel/product safety/product complaints
• Undesirable effect assessors
• R&D
• Regulatory affairs professionals
• Quality control and assurance
• Responsible persons

Popular with...

This course has proven particularly popular among our customers in these roles:

• Medical Affairs Manager
• Regulatory Manager
• Senior Manager Pharmacovigilance Epidemiology & Risk Management

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