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.
CPD Hours: 12
Course Content
- Day 1
- An introduction to cosmetovigilance
- Causality assessments in cosmetovigilance
- The Product Information File (PIF)
- Safety signal analysis - what is a signal?
- Safety signal analysis -the signal and actions?
- Borderline products & cosmetics
- Day 2
- Annual product safety report
- The regulators perspective for cosmetovigilance
- The Responsible Person for cosmetovigilance
- The practical role of the Responsible Person for cosmetovigilance
- The practical role of the Responsible Person for cosmetovigilance (continued)
- Promotional claims for cosmetics
Speakers
Graeme Ladds
Graeme Ladds, Director of PharSafer, has over 30 years’ experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.
Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug-device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.
