Artwork review is often perceived as a routine regulatory task. However, inaccurate or poorly reviewed artworks can pose significant risks to patient safety, disrupt manufacturing timelines, and lead to regulatory non-compliance. This focused webinar provides practical guidance on the review of medicinal product artworks and mock-up materials for the EU market from the perspective of a Global Artwork Coordinator.
The session highlights key review checkpoints for package leaflets and outer packaging, including text accuracy against approved product information, formatting considerations, country-specific requirements in Europe, readability, Braille, and blue-box obligations.
Drawing on real-world experience, the webinar emphasizes a pragmatic approach to artwork coordination, outlining when to approve, when to question, and when to escalate. This enables participants to support efficient and compliant artwork processes within regulatory framework.
This webinar is particularly relevant for professionals involved in the coordination, review, and approval of medicinal product artworks in Europe.
Join us 3 June at 12:00 UTC
Presenter: Luka Lazauskiene is experienced Regulatory Affairs professional with 10 years of experience in the pharmaceutical industry, specializing in labelling and medicinal product lifecycle management. She has worked with regulatory service providers, representing a wide range of Marketing Authorisation Holders, which has given her exposure to a broad and diverse portfolio of medicinal products.
Through her roles, she has gained extensive hands-on experience with regulatory procedures across EU countries, including variations, renewals, and other post-authorisation changes, as well as the practical application of approved labelling content into artworks.
Her main professional focus is the end-to-end lifecycle management of medicinal products, ensuring that artworks remain compliant, accurate, and aligned with evolving regulatory requirements.
Agenda:
- Introduction and Context
- Reference Texts and Review Readiness
- Package Leaflet Review – Key Focus Areas
- Outer Packaging Components
- Special Cases
- Key Takeaways
Who should attend this webinar?
- Global Labelling Coordinators / Managers
- Regulatory Affairs Professionals
- Artwork Management / Artwork Coordinators
Language: English
Duration: up to 40 min.
The webinar is free of charge, register to attend.
Have any questios? Feel free to contact us!