About
Navigating Regulatory and Clinical Pathways for Cosmetic Products: A Practical Masterclass
Successfully navigating the EU cosmetic regulatory landscape requires clear understanding, practical tools, and the ability to make the right decisions early.
This expert-led online training offers a structured and practical overview of the regulatory and clinical requirements applicable to cosmetic-use products in the European Union.
Designed for both newcomers and experienced professionals, the program focuses on product classification, borderline scenarios, and clinical evidence expectations, helping participants confidently apply EU Cosmetics Regulation, MDR (including Annex XVI), and relevant food supplement legislation to achieve compliant and efficient market access.
Key topics covered, are:
- Introduction to the regulatory framework for cosmetic-use products
- Differentiating between cosmetics, medical devices, food supplements, and medicinal products
- Understanding borderline product classifications and decision trees
- Clinical evaluation and evidence requirements for market access
- Case studies: Product classification and European market entry
- Regulatory strategies and optimal routes to market in the EU
Programme
Module 1
- Welcome & Introduction
- EU Regulatory Landscape: Foundations and Key Legislations
- Differentiating Product Types and market access: Cosmetics, Medical Devices, Food Supplements, Medicines
- Borderline Products: Guidance and Classification Tools
- Clinical and Technical Evidence: Requirements for Technical Documentation
- Wrap up – conclusion of day 1
Module 2
- The EU Medical Devices Regulation (MDR) Annex XVI Implications for Cosmetic-like Devices
- Preparing Regulatory Submissions and compliance: Dossiers, Notifications, Inspections
- Latest Trends, and Regulatory Updates
- Case Study: Market Access Pathways in EU, UK, CH
- Questions and Answers – conclusion of day 2
- Cosmetic, Medical Device and Food Supplement industry professionals
- Regulatory affairs specialists and managers
- R&D and innovation leads
- Quality assurance and compliance teams
- Commercial leads
This interactive training combines short knowledge quizzes, guided group discussions on real-life case studies, and a practical exercise focused on claims and clinical data preparation, ensuring an applied and engaging learning experience.
Claims and clinical data preparation exercise.
Lecturers
Arkan Zwick
Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 20 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures at University of Applied Sciences (IMC Krems) and speaks regularly at international conferences.
Online Training – 2 modules:
MODULE 1 | 04 November 2026 from 2:30 pm to 5:30 pm CET
MODULE 2 | 05 November 2026 from 2:30 pm to 5:30 pm CET
Some days before the online training 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: € 690,00* (until 14 October 2026)
Ordinary: € 885,00*
Freelance – Individual – Academy – Public Administration: € 495,00*
* 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.
Register
Accepted payment methods: Bank Transfer, Credit Card, PayPal.
Ilaria Butta
Events & Training Manager
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
