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Publications by authors named "Steve Estevao"

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The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Giovanni Tafuri Inês Lucas Steve Estevão Jane Moseley Anne d'Andon

Br J Clin Pharmacol

May 2018

Aims: The parallel regulatory-health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought.

Methods: Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed.

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Synopsis of recent research by authors named "Steve Estevao"

  • - Steve Estevao's research focuses on the effectiveness of the parallel regulatory-health technology assessment (PSA) procedure, which allows drug manufacturers to receive simultaneous feedback from regulatory agencies and health technology assessment bodies during clinical development.
  • - His 2018 study analyzed the integration of PSA recommendations in clinical development plans, examining advice provided by regulators and HTA bodies between 2010 and 2015.
  • - The findings highlight the role of PSA in shaping clinical development strategies and suggest potential improvements in the uptake of regulatory recommendations to enhance the drug approval process.

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