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