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EMA pilot will see if clinical trial data should be digested ‘raw’

pharmaphorum

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors. It may also help the regulator to define target treatment populations better.

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Creating an effective patient engagement set of practices that is enduring and future-proof

pharmaphorum

The ‘PEP Talks’ monthly e-newsletter has approaching 50 pharma companies as subscribers and the inaugural ‘Patient Engagement Day’ on September 01 st achieved an inspirational number of downloads of toolkits for ways to ‘Amplify the Patient Voice’ as the launch theme. Will pharma listen, and is this even their role to do so?