Primum non nocere (“First do no harm”) is the principle that underlies all health care.  There is no task more critical to the credibility of a pharma organization than the timely, accurate and appropriate reporting of adverse events.  With both direct patient care, as well as extensive regulatory experience, Michael Kurman Consulting brings a unique and balanced perspective to the reporting of drug safety.

  • Medical monitoring
  • Expedited safety reporting
  • Safety review
  • SAE narrative/Analysis of similar events