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