Post marketing Safety Management is a very important area of a Good Clinical Practice (GCP) and Good Vigilance Practice (GVP). This is why the FDA has very detailed and clearly laid out requirements that organizations and sponsors of clinical research have to comply with as part of meeting safety requirements.
The FDA’s requirements on post marketing safety management are laid out in a number of its sections, namely 21 CFR 310.305, 314.80, 314.98, 600.80, and 600.81. Primarily, these sections of the FDA require organizations or sponsors to report the following:
- Serious and unexpected adverse experiences that can occur from either foreign or domestic sources
- Spontaneously reported adverse experiences that occur domestically and that belong to any of these categories:
- Serious and expected
- Nonserious and unexpected
- Nonserious and expected
Who should report post marketing safety management?
Post marketing safety management is to be taken care of and reported by personnel who have been entrusted responsibilities relating to safety reporting. These include:
What is to be reported as part of post marketing safety management?
The FDA states clearly that the following need to be reported as part of post marketing safety management:
- Any adverse event associated with the use of a drug or a biological product
- Serious adverse experiences, whose reporting is necessitated by any of the following:
- An experience in which the subject felt that her life was threatened
- Any experience that causes the patient’s stay in hospital to be prolonged
- An experience in which the patient was left with a debilitating condition on account of the clinical research
- A defect that occurs in the womb
- Post marketing safety management also requires reporting on experiences in which the patient (or subject) develops an allergic bronchospasm that requires intensive intervention and hospitalization
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