The European JCA is already “living reality” for companies submitting their oncology / ATMP assets to the EMA; very soon, orphan drugs & all other drugs will follow. It is already clear that it will not replace national HTAs, so can be seen as an add-on hurdle. But what is needed in preparation of the JCA, and what exactly means early PICO scoping? In this Webinar, the speakers will address these questions and will present how an early JCA preparation that is supported by a customized tool can be done and how it can also support subsequent national HTA submissions in Europe.
Topics covered by this webinar are the following:
European JCA: what is needed, how does it work?
Early PICO Scoping: how to do it?
How to prioritize PICO-specific evidence needs?
Evidence Generation Options for comparative evidence
RCT Evidence
External Control Groups
Naïve Comparisons
Indirect Treatment Comparisons
A Process- and tool-driven proposal to do early JCA Planning
Speakers
