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Session 1: Preparation for JCAs - Navigating The Complexity of Future JCA
Session Chair(s)
Lara Wolfson
AVP & Head, HTA Statistics
MSD Switzerland, Switzerland
Ansgar Hebborn, PHD, MBA
Head - Access Policy Affairs Europe
F. Hoffmann-La Roche AG, Switzerland
Joint Clinical Assessment (JCA) dossiers will need to be submitted by health technology developers (HTD)s 45 days prior to final CHMP regulatory opinions, based on PICO(s) that will be communicated only during the regulatory process. Preparing such dossiers in short times - and with uncertainties about needed content and scope - will pose operational and logistical challenges. In this session, we will discuss how the complexity of the PICOs and dossier landscape can be navigated.
Speaker(s)
Industry proposals to reduce complexity of EU21 PICO survey concept
James Ryan, MSC
AstraZeneca (Global), UK, United Kingdom
Director, Global HTA Policy
The A to Z of getting to JCA submission within D-45: Process and other operational considerations building on learnings from the experience with preparing complex clinical evidence dossiers (e.g. Germany)
Thomas M Ecker
Ecker + Ecker GmbH, Germany
CEO