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What is the meaning of drug safety?

Drug safety refers to the frequency of adverse drug effects (i.e., physical or laboratory toxicity that could possibly be related to the drug) that are treatment emergentthat is, they emerge during treatment and were not present before treatment, or they become worse during treatment compared with the pretreatment

What is the pharmacovigilance reporting process?

A pharmacovigilance system is a system used by a country and its authorized technical entity to fulfil its legal obligations and responsibilities in relation to pharmacovigilance. It is designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance.

What is the definition of a safety report?

safety report means a report in respect of the Program, setting out the hazard identification and risk assessment for the production of the Program and the measures put in place to eliminate or, if that is not reasonably practicable, to control those risks.

What is an IND safety report?

Investigational New Drug (IND) regulations require that a narrative or tabular summary of the most frequent and most serious adverse events be reported to the FDA in the annual report. However, serious and unexpected suspected adverse reactions must be reported quickly in the form of an IND Safety Report.

What is a safety alert for a drug?

A safety alert tells you about a possible risk or action you need to take for a health product. This alert doesnt always mean a medicine or medical device product is unsafe.

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