Join Chantal & Sigrid on Thursday, June 27th, 2024, at 14:00 BST / 15:00 CEST / 9:00 EDT for the first episode of our webinar series on the upcoming European Health Technology Assessment (HTA) regulation.
In this first episode, Chantal Van Gils & Sigrid Klaar will cover every aspect of the new regulation, focusing on the critical Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs), that will first apply to oncology drugs and advanced therapy medicinal products (ATMPs) from January 12, 2025.
Why you should attend
• Stay Ahead of Regulatory Changes: Understand the implications of the new EU HTA regulation and how it integrates with the Marketing Authorization Application (MAA) timeline.
• Prepare Proactively: Learn how to anticipate the scope of the JCA, prepare for evidence generation, and utilize JSC opportunities to ensure timely and effective dossier preparation.
• Enhance Cross-Functional Collaboration: Gain insights on fostering strong internal collaborations to support successful implementation.
• Expert Guidance: Benefit from the knowledge of ex-regulators and industry experts who will guide you through the complexities of the new regulation.
Focus
- Introduction to Health Technology Assessment (HTA) and the differing needs of payers and regulators.
- Detailed explanation of the EU HTA Regulation.
- Understanding the implications for companies in the biotech and drug development sectors.
