Dublin , Dec. 18, 2023 /PRNewswire/ — The “Cosmetovigilance Training Course” conference has been added to ResearchAndMarkets.com’s offering.
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.
Benefits of Attending
Hear the differences in the global requirements
Understand Causality Assessments in Cosmetovigilance
Know how to manage The Product Information File (PIF)
Learn about Safety Signal Analysis
Understand the role and responsibilities of The Responsible Person for Cosmetovigilance
Discuss borderline products and cosmetics
Be aware of the advertising regulations for cosmetics
Who Should Attend:
Customer Call Personnel/Product safety/Product Complaints
Undesirable effect assessors
R&D
Regulatory affairs professionals
Quality control and assurance
Responsible persons
Agenda
Day 1
An Introduction to Cosmetovigilance
New EU Legislation
USA & Rest of World reporting
What needs to be reported
Data capture techniques
Causality Assessments in Cosmetovigilance
Legal basis for causality assessments
Types of causality
Where causality assessments appear
Determining causality
The Product Information File (PIF)
Availability and purpose
Composition
Maintenance and updates
Safety Signal Analysis – Part A – What is a Signal?
What is a signal?
Where to look for signals
Literature
Individual reports
Pre-Clinical findings
Safety Signal Analysis – Part B – The Signal and Actions?
Trending over time
Quality of the reports
Potential signals and their handling – communication
Regulators
Public
Borderline Products & Cosmetics
What is a borderline product?
What does this mean for Cosmetics
Safety reporting for a product that is Device and Cosmetic?
Day 2
Annual Product Safety Report
Product Safety Information
Subsections for the Safety Information
Product Safety Assessment
Information for the Safety Assessment
The Regulators Perspective for Cosmetovigilance
Regulatory Inspections for Cosmetics
USA
Europe
ROW
The Responsible Person for Cosmetovigilance
The role of the Responsible Person
Qualifications and Expectations from the Regulatory Agencies
The Practical Role of the Responsible Person for Cosmetovigilance
The role of the Responsible Person with:
Ingredients, labelling and claims compliance
Configuration and custody of the Cosmetic Product Information File (PIF)
Configuration of the Cosmetic Product Safety Report (CPSR)
The Practical Role of the Responsible Person for Cosmetovigilance (continued)
The role of the Responsible Person with:
Product notification on the Cosmetic Products Notification Portal (CPNP)
Post-market surveillance
Review of Nanomaterials and Carcinogenic, Mutagenic and Reprotoxic (CMR) substances
Promotional Claims for Cosmetics
The regulations for advertising cosmetics
Medical claims
Penalties for false advertising
Speakers:
Graeme Ladds
Director
PharSafer Associates Ltd.
Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme 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.
For more information about this conference visit https://www.researchandmarkets.com/r/kt7o5w
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SOURCE Research and Markets
