Introduzione
Cosmetovigilance is the system that monitors and ensures the safety of cosmetic products in the European Union. This course will introduce you to the key regulations, responsibilities, and reporting requirements in the field.
You will learn about the role of the Responsible Person and how to manage product safety effectively. The training also covers how to identify and report serious undesirable effects of cosmetics.
By the end of the course, you will have the knowledge to navigate EU cosmetovigilance regulations and apply risk management principles.
This course will provide:
- An introduction to cosmetics and cosmetovigilance
- An overview of the EU Cosmetovigilance regulations
- Information on the role of the Responsible person for Cosmetovigilance and their responsibilities
- Guidance on safety assessment and risk management
- Explanation of “Serious undesirable effects” and their reporting guidelines
This course is designed for professionals working in the cosmetic industry who are involved in product safety, compliance, and regulatory affairs.
Participant experience
This is an introductory course, and no previous experience is required.
Interactive lecture that includes Q&A, quizzes and practical examples to build understanding and confidence in the newly gained knowledge.
Docente/i
Enej Šterbenc
Enej began his professional career as a physician. After leaving clinical practice, he joined Billev Pharma East as a Medical advisor. In his current position, he is part of a team ensuring the safety of medical products. He also participates in various projects bringing new products to market.
Lara Šterbenc
Lara holds a Master’s degree in Pharmacy and began her career as a Regulatory Affairs Manager at Krka d.d. Novo mesto, overseeing compliance and regulatory processes for various EU and non-EU markets. She transitioned to Billev Pharma East, where she continues her work as a Regulatory affairs manager. Her work covers all aspects of regulatory affairs with a current focus on EU markets.
Online Training – 1 module
20 October 2025 from 2:00 pm to 6:00 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 515,00* (until 29 September 2025)
Ordinary: € 645,00*
Freelance – Individual – Academy – Public Administration: € 435,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Cosa saprai fare dopo il corso