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 the Corporate Regulatory Affairs Director at a private global pharmaceutical and surgical company with products in ophthalmology, orthopedics, and aesthetic dermatology. With over eighteen years of regulatory experience, his responsibilities span advocacy for drug, medical device, combination product, and cosmetic compliance, as well as providing in-house legal support for contract management, mergers and acquisitions, and intellectual property matters. Mr. Zwick ensures regulatory compliance in the EU, collaborates with various notified bodies, and manages global market authorizations in the Americas and Asia-Pacific. He holds a master’s degree in law from the University of Vienna and a PhD in European Law, teaches at the University of Applied Sciences in Vienna, and is a frequent speaker at life cycle conferences and trainings. He is fluent in English, German, and French.
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
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.
