Studi trials: training for Missione MSL

On 22 July Massimo Zaninelli, CEO of Maxer Consulting, presented the training session dedicated to “Clinical studies: from submission to AIC” to the young participants of Missione MSL.
The lecture outlined the overview of the process that leads from the design of a study to the marketing authorization of the new drug. These are the topics covered:

  • EU: clinical trial process
  • US: clinical trial process
  • Transparency of results
  • Application of Reg 536/2014 in Italy

The interest shown by the participants underlined the value they attribute to the development of new drugs as a tool for their professional background.