Join our experts Chantal W.M. van Gils & Sigrid Klaar on Thursday, 5th June at 14:00 BST | 15:00 CEST | 09:00 EDT for the fourth installment of our webinar series on the European Health Technology Assessment (HTA) regulation.
The EU Health Technology Assessment (HTA) Regulation is now in effect, and companies submitting new oncology drugs and/or ATMPs, for EU market approval must navigate the Joint Clinical Assessment (JCA). A Joint Scientific Consultation (JSC) is the key opportunity for Health Technology Developers (HTDs) to align their clinical development plans with HTA expectations – but access is limited, timing and preparation are critical, and alternative options must be well understood.
What you will learn
The Role of Joint Scientific Consultation (JSC) in EU HTA Strategy
- Why early engagement with HTA bodies is important for market access.
- How a JSC can help you de-risk your Joint Clinical Assessment (JCA).
The JSC Process – a walkthrough
- How the JSC procedure works—from submission to outcome.
- The importance of timing
- Parallel EMA-HTA JSC – an opportunity for connected advice
Strategic Considerations: How to Prepare
- What HTA bodies are looking for, and how to align your clinical trial design/evidence generation strategy
- How to submit a JSC briefing package– pitfalls to avoid.
What if you don’t get a JSC? Alternative Advice Pathways
- National HTA consultations – engaging directly with country-specific agencies.
- Consultation with HTA experts/payers
