OPALIA RECORDATI S.A - Tunisia

Pharmacovigilance



The role of pharmacovigilance is threefold

Detect, assess and monitor the risks associated with the use of all medicines at Opalia Recordati. Research and implement measures to reduce and prevent the occurrence of adverse events Promote the correct use of the drug and guarantee its safety. This mission is carried out continuously with the competent authorities and all health professionals in order to improve knowledge of the products and to better control the risks in their actual conditions of use.

The result of this work allows: To optimize the benefit / risk ratio of a drug. To determine the best treatment for a given patient. Inform doctors about the possible risks associated with the product. To propose the conditions for placing a product on the market.

Raise awareness and train in pharmacovigilance

The pharmacovigilance / epidemiology department of Opalia Recordati aims to set up a new training program to make all employees aware of the importance of pharmacovigilance and its procedures. This training will aim to be rolled out to the entire Group, including to medical and sales visitors. This awareness program will remind you of the basic safety rules, present the organization put in place, and detail the tools available as well as the procedures to be followed. Specific training will also be available for managers dedicated to pharmacovigilance within the group, to ensure that their knowledge is regularly updated. This training program will allow, among other things, to respect Opalia Recordati's commitments to comply with all the reporting obligations of adverse events within the deadlines set by national and international regulations.

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A solid regulatory environment

Pharmacovigilance is a highly regulated area in the pharmaceutical industry. Many regulations, general policies and recommendations exist, particularly at the Tunisian, European, International and American level Compliance with these rules is the guarantee that the best levels of patient safety practice are maintained. Within the Pharmacovigilance and Epidemiology department, those responsible for evaluating product safety are responsible for analyzing and managing all the potential signals emitted by each product, as well as documenting them. And this, whatever the origin of the signal.