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Are you a sponsor who is seeking joint scientific advice from a regulatory agency and from an HTA body?

If yes, this episode is for you. This presentation replicates the discussions which may go on during scientific advice. The example was in Respiratory. This roleplay is played by David Wright, Oliver Keene, Stephen Ruberg, and myself. The aim is to show a couple of discussion points and an interesting aspect that may come up with such discussions.

A lively debate followed about the differing needs of Regulatory agencies vs HTA, with the patient voice often not taking centre stage.

We will also be talking about the following:

• Estimand for pivotal trials 5062018 and 5062019 (identical trials)
• Specifically strategy for intercurrent events

Listen to this episode and share it with others, who might learn from it!

Link to the video on demand side on the PSI homepage!

Link to the slides for the introduction.