Management of Variations in the New EU Framework: What’s Changing and How to Prepare

ProductLife Group is pleased to present a dedicated webinar providing regulatory and operational guidance on the new EU Variations Framework following the introduction of Regulation (EU) 2024/1701 and the subsequent publication of the long-awaited variations classification guideline (C/2025/5045).

These regulatory updates represent one of the most significant revisions to the EU variations system in recent years, reshaping procedures for Competent Authorities, Marketing Authorisation Holders (MAHs), and manufacturers.
This session has been designed to help regulatory professionals navigate the transition with clarity, accuracy and confidence.

This session provides a clear and practical overview of the regulatory changes and their implications for daily operations. Key topics include:

• Main updates introduced by Regulation (EU) 2024/1701
• Structure, scope and interpretation of the new classification guideline C/2025/5045
• Expected impact on MAHs, manufacturers and Competent Authorities
• Adaptation of internal processes to ensure readiness and compliance
• Practical recommendations to support the transition to the new framework

Participants will gain actionable insights to align resource planning, documentation management and regulatory pathways with the updated requirements.

ProductLife Group remains committed to supporting companies in adapting to evolving EU requirements with expert guidance, targeted training and end-to-end regulatory support.
Through this webinar, PLG reinforces its mission to help organisations anticipate regulatory change, maintain compliance and ensure efficient, robust processes throughout the product lifecycle.

🗓️ 15 December 2025 | 🕒 12:00 CET

📍 Format: Free online webinar hed in English

🎙️ Speaker: Raffaella Pandini