According to the World Health Organization, “Pharmacovigilance (PV) is defined as the science and activities..
Given the specific IND safety reporting requirements for the sponsor, drug safety operations and management..
Annual Reports Requirements for Safety are listed in the 21CFR Part 312.33(b). This list includes summary information..
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding..