Early dialogue in Europe: perspectives on value, challenges, and continuing evolution

EMA

24 September 2018 - This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies in Europe.

Eleven semi-structured interviews were arranged purposively with experienced people from the pharmaceutical industry, the EMA and an expert in health economics. 

The interview questions focused on the value of early dialogue, the challenges faced during the process of early dialogue, the best time to start an early dialogue, the kind of products most suitable for early dialogue, the current situation, and future perspectives for the early dialogue process. The interviews were recorded and then transcribed for open and axial coding to summarise the findings.

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Michael Wonder

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Michael Wonder