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
Certification:
- CPD: 12 hours for your records
- Certificate of completion
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
Mr 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.
Who Should Attend
- Customer Call Personnel/Product safety/Product Complaints
- Undesirable effect assessors
- R&D
- Regulatory affairs professionals
- Quality control and assurance
- Responsible persons
