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Insights Into the Decision Making of Advisory Groups to the Italian Medicines Agency

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Abstract

The Italian Medicines Agency (AIFA) is enhancing a strong transparency-oriented policy to improve information exchange and decision making with stakeholders. To this end, a questionnaire titled “Survey AIFA 2013” was sent to the 72 selected contacts on February 17, 2013 (closing date April 3, 2013), to assess influence on committees and secretariats’ opinions and decisions. The survey was divided into 2 sections (17 questions) with a 10-minute time limit. The results show that external resolutions have little influence on internal advisory groups, whereas internal ones carry more weight. So-called intellectual bias needs careful monitoring, as it can potentially condition decisions.

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References

  1. McIntyre TD. How FDA Advisory Committee Members Prepare and What Influences Them. Bethesda, MD: 3D Communications; 2012.

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  2. AIFA regulation on conflict of interest. http://www.agenziafarmaco.gov.it. Published February 2012.

  3. European Medicines Agency policy on the handling of conflicts of interests of scientific committee members and experts. EMA/513078/2010. http://www.ema.europa.eu. Published April 3, 2012.

  4. European Medicines Agency strengthens rules on conflicts of interests of its scientific experts: new rules aim for a more robust, efficient and transparent process. EMA/624730/2010. http://www.ema.europa.eu. Published October 14, 2010.

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Correspondence to Michele Marangi PharmD.

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Marangi, M., Cammarata, S.M. & Pani, L. Insights Into the Decision Making of Advisory Groups to the Italian Medicines Agency. Ther Innov Regul Sci 48, 696–701 (2014). https://doi.org/10.1177/2168479014529571

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  • DOI: https://doi.org/10.1177/2168479014529571

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