Burguet LN, Troche CY

Language: Spanish
References: 14
Page: 339-347
PDF size: 52.07 Kb.

ABSTRACT

Introduction: pharmacosurveillance is a shared responsibility of the physicians, the pharmaceutical industry, the health authorities and the patients. However, Liorad Laboratories had not defined the implementation of this procedure yet.
Objective: to establish the working strategy to be followed by the institution to put pharmacosurveillance into practice at the industrial level.
Method: the outlined strategies were the selection of a person to take on responsibility for pharmacosurveillance, the definition of the regulatory framework to rule the same, setting up of the information flow, definition of the documentary system to obtain documented evidence and assessment of the design of aftermarket studies.
Results: one specialist from the research, development and innovation division was appointed to lead the pharmacosurveillance activity as well as his/her working functions were drafted. The appointed professional was trained in industry-oriented pharmacosurveillance. The regulatory framework was defined as the set of rules governing this activity at domestic level. The documents required for facilitating the organization of this activity and recording all the work done were finally drafted, reviewed and approved. Finally, it was decided that the fundamental design to carry out the aftermarket studies would be based on the research of adverse, unusual and unexpected events and the detection of rises in the incidence of known adverse reactions.
Conclusions: once the work is finished, there is an organizational infrastructure that enables the company to take on this task since the industrial phase, which will contribute to early detect unexpected events that could alter the risk-benefit balance of medicinal products manufactured at Liorad Laboratories.

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