This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). 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.
9-10 October 2023
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.
This course is part of our Vigilance Training Course collection, which features other pharmacovigilance training courses for professionals.
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
9-10 October 2023
09:30-16:45 UK (London) (UTC+01)
10:30-17:45 Paris (UTC+02)
04:30-11:45 New York (UTC-04)
Course code 14172
Until 04 Sep
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: