Introduzione
Compliance with the regulatory requirements applicable to cosmetic products, ensuring the highest level of safety for consumers, is considered the most important factor for growth of a cosmetic brand.
In selecting your suppliers and ingredients, in developing your formulations, in deciding on your product positioning and claims, and in rolling out your sales and distribution, it is important to understand the European Union regulatory framework applicable to cosmetics.
This introductory course will provide you with a grounding knowledge of regulatory affairs of cosmetics in the EU market and a practical insight into the European regulatory environment throughout the whole product life cycle.
Overview of EU Cosmetics Regulatory Framework
- Regulation (EC) No. 1223/2009 on Cosmetic Products
- Cosmetic Regulatory Definition and Borderline Products
- Economic Operators along the Supply Chain
- Responsible Person: definition and obligations
Regulatory Requirements – From Concept to Market
- R&D of cosmetic formulations for placement in the EU market
- Good Manufacturing Practices (GMP)
- Product Information File (PIF): structure and contents
- Safety Assessment Report: structure, contents, and responsibilities of the EU Safety Assessor
- Labelling Requirements
- Advertising, Proof of Claims and Alleged Effects
- Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance – Cosmetovigilance obligations
Q&A Session
- Professionals in the cosmetic and personal care industries new to EU Cosmetics Regulatory Affairs or wishing to update their knowledge on the EU regulatory landscape.
- Regulatory Affairs, Registration and Documentation Assistants/Officers/Managers and Quality Assurance professionals seeking to improve their skills in the cosmetic’s regulatory environment.
- R&D professionals involved in development of cosmetic formulations for the EU market. Marketing professionals involved in cosmetics label preparation and market placement.
- Project Management or Business Development officers who would find knowledge of the regulatory environment useful.
Training will be in the form of an interactive workshop. It will include presentations, discussions, and Q&A.
Docente/i
Liliana Teles
Liliana Teles is a pharmacist holding Masters in Pharmaceutical Sciences and Pharmaceutical Medicine, with more than 10 years of experience in Medical Devices and In Vitro Diagnostics Regulatory Affairs & Quality Assurance. At Critical Catalyst, her work is focused in supporting medical device Manufacturers, Distributors, and Importers in achieving regulatory compliance. Experienced in implementation and audit to Quality Management Systems according to ISO 13485 and Good Distribution Practices of medical devices.
Passionate about working with dedicated teams, driving projects related to regulatory compliance in the medtech field and streamlining patients access to medical device technology.
Online Training – 2 modules
MODULE 1 | 14 June 2022 from 2.00 pm to 5.30 pm CEST
MODULE 2 | 16 June 2022 from 2.00 pm to 5.30 pm CEST
After the registration, you will receive all details about the connection.
The course admits maximum 12 attendees.
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: € 770,00* (until 17 May 2022)
Ordinary: € 960,00*
Freelance – Academy – Public Administration**: € 500,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.