(MENAFN- GlobeNewsWire - Nasdaq) Discover the latest in global cosmetovigilance with our comprehensive course. Explore regulations, safety assessments, and the role of the Responsible Person. Gain insights for cosmetic, pharmaceutical, and medical device sectors. Earn 12 CPD hours and a completion certificate.

Dublin, July 28, 2025 (GLOBE NEWSWIRE) -- The "Cosmetovigilance Training Course" 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

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Who Should Attend:

• Customer call personnel/product safety/product complaints
• Undesirable effect assessors
• R&D
• Regulatory affairs professionals
• Quality control and assurance
• Responsible persons

Key Topics Covered

Day 1

An introduction to cosmetovigilance

• New EU Legislation
• USA and 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 - what is a signal?

• What is a signal?
• Where to look for signals
• Literature
• Individual reports
• Pre-Clinical findings

Safety signal analysis - 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

For more information about this training visit

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