The introduction of the EU HTA Regulation has brought Joint Clinical Assessment to the top of the agenda for biotech sponsors. JCA is mandatory, runs in parallel with EMA timelines, and places new demands on evidence generation, trial design and cross-functional alignment earlier in development than many companies anticipate.

As the first JCA submissions are now underway, early patterns are emerging. The PICO scope remains a central challenge, and the gap between regulatory and market access thinking continues to create operational strain for smaller organizations.

In this webinar we cover practical strategies for JCA readiness, from predicting your PICO scope and optimizing your pivotal trial, to understanding the implications for business development and out-licensing.

Watch the recording below or download the PDF summary for practical guidance and early learnings.

Hosts

Dr Chantal W.M. van Gils

VP Evidence and Value

Mel Walker

CEO & Founder, Access InVivo

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Building Better Biotechs