Breaking into Europe: Regulatory and Market Access Essentials for Digital Health Companies
CMC Development of New Small Molecule Products
IVDR Performance Evaluation IVDs, RUO & In House
Serialization Italy, Europe & Global Outlook
Management of Variations in The New Frameworks: what’s changing and how to prepare
Marketing Authorization Transfers and Considerations for Successfull Implementation and Integration
Management of Variations in the New Frameworks – ITALIAN
IVDR Transition Period Extension – Breathing Room Amidst Persistent Challenges
While this extension offers manufacturers valuable additional time to align with the regulation, significant compliance challenges still remain. This session will explore how organizations can strategically adapt to evolving IVDR expectations while maintaining operational continuity.
Self-Care
Novel Food webinar Preview
Webinar about Novel Food regulatory Framework and scientific requirements for novel Foods - Preview