A replay of the PSI Conference 2018
Are you a sponsor who is seeking joint scientific advice from a regulatory agency and 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 was played by David Wright, Oliver Keene, Stephen Ruberg, and myself. Mouna Akacha moderated the discussion. The aim was 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 center stage.
We will also be talking about the following:
- Estimand for pivotal trials
- Specifically strategy for intercurrent events.
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