Clinical trials for medical devices


Clinical trials for medical devices

Temas srl - Forum Institute of Management GmbH organize an intensive seminar on "clinical trials on medical devices". Dr. Armando De Vincentiis (CSO-THS-Therapeutic Solutions srl), Eng. Elena Venturelli (Medical Device Advisor Merc srl) and Dr. Antonio Parisi (Director Office VI - Clinical trials on medical devices - Ministry of Health) will be the speakers of the seminar. The Seminar will be held on 2 April 2014. at NH Machiavelli Hotel Via Lazzaretto, 5 - Milan.

Topics covered:

  • Regulatory Requirements for the driving of a clinical trial on medical devices
  • Development of the study and investigator brochures protocol
  • Documentation to be submitted for the authorization application
  • What to do in case of significant changes to the study protocol?
  • Possible critical issues in the process of carrying out the trial
  • When and how to report any adverse reactions?

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