Research and Markets: Cosmetovigilance - Ensure You Comply with the New EU Regulations

DUBLIN--()--Research and Markets ( has announced the addition of the "Cosmetovigilance - Ensure You Comply with the New EU Regulations (Course, London)" conference to their offering.

The Cosmetovigilance course will take place on 03 July 2014 at The Rembrandt Hotel, London

This one day course is intended to help all people working in the area of cosmetics to understand what is required under the new EU Regulations for Cosmetovigilance. For a long time the Cosmetics Industry has remained, not only separate to the rest of the Pharmaceutical Industry, but also away from the strict constraints concerning product composition changes; reporting adverse reactions; noting trends in adverse events and careful monitoring and understanding of why adverse events happen.

Under the new EU Regulations, Cosmetic Companies are now required to have information clearly available to the Regulatory Authorities concerning their cosmetic products and their composition as well as safety assessments of those products, derived from the reports received from consumers and the scientific literature.

This course clearly provides what is required for compliance with the new Legislation and what exactly is required in terms of documentation on company products, as well as the individual responsibility given to the Responsible Person for Cosmetovigilance.

Course Features

  • Gain a Thorough Understanding of the New EU Regulations for Cosmetovigilance
  • Discuss Causality Assessments - their Legal Basis and the Types of Causality
  • Receive Practical Tips on Carrying out your Safety Signal Analysis
  • Understand the Role of the Responsible Person
  • Learn how to Design your Annual Product Safety Report


Personnel working in Cosmetics, especially Product Managers, Responsible Persons as well as anyone needing an update in the area of Cosmetovigilance.


Delegates will receive a course material folder containing comprehensive documentation provided by the course tutor which will be a valuable source of reference for the future.

A Certificate of Attendance for Professional Development will be given to each participant who completes the course

Key Topics Covered:

09.30 - An Introduction to Cosmetovigilance

- New EU Legislation

- USA & Rest of World reporting

- What needs to be reported

- Data capture techniques

10:30 - Causality Assessments in Cosmetovigilance

- Legal basis for causality assessments

- Types of causality

- Where causality assessments appear

11:30 - The Product Information File

- Availability and Purpose

- Composition

- Maintenance and Updates

13:30 - Safety Signal Analysis

- Trending over time

- Quality of the reports

- Potential signals and their handling

14:30 - The Responsible Person

- The role of the Responsible Person

- Qualifications

- Document reviews and safety

15.15 - Tea

15.35 - Annual Product Safety Report

- Product Safety Information

- Subsections for the Safety Information

- Product Safety Assessment

- Information for the Safety Assessment

16.45 - End of Seminar

For more information visit


Research and Markets
Laura Wood, Senior Manager
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Pharmaceuticals


Research and Markets
Laura Wood, Senior Manager
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Pharmaceuticals