Course overview
The regulations for cosmetic products globally have been in place for nearly 50 years and have been changing and growing worldwide. Previously there had not been a requirement to test cosmetics in the same manner as medicines because of perceived lack of effect or ‘danger’ to the consumer.
The identification and analysis of adverse reactions (Serious Undesirable Effects (SUEs)), related to cosmetic products is a process that used to be mainly industry driven. However, it is now the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed, and to then collect reports of undesirable effects similar to the pharmaceutical industry, and conduct safety summaries of their products.
The rules that apply to cosmetics differ from country to country, including how to collate data for the Product Information File (PIF), safety reviews, causality assessments, reporting, and other areas of the legislation.
This course will provide a comprehensive overview of Cosmetovigilance in Europe, the USA and the Rest of the World (ROW). It will cover the applicable legislation, the regulatory requirements, what needs to be reported, the role of the Responsible Person, borderline products and promotional claims.
Essentially it will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access 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.
