What makes a compliant Phase III and pre-launch patient strategy?
In some ways compliance could be seen as less of a concern in early development because there is no product so to speak, but unlike existing treatments where the rules are very clear, there is no compliance precedent in earlier stages.
The peer reviewed report, which has just been published in the Journal of Market Access and Health Policy, is based on contributions from over 50 European industry executives and expert comment from senior advocacy and compliance consultants & a leading European patient group. It examines the biggest compliance concerns for pharma executives at the time of Phase III; offers practical advice on how to engage with patients in early development and provides best practice principles for a compliant advocacy programme during these increasingly important R & D stages.
You will also be able to sign up for If Medicines Could Talk™ my monthly video blog on patient engagement in early development. The first episode is with one of the the study authors talking in detail about the patient group implications of a compliant advocacy strategy. Further episodes will involve interviews with the other study authors.
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