The world of pharmacovigilance is growing in importance every day as medical product manufacturers expand their sales and distribution efforts in the global marketplace.
New York, US (PRWEB) August 23, 2013
The three main contributors and authorities in pharmacovigilance are the industry, payors and competent authority. The pharmocoviligance process, for organizations involved, is preferably conducted continuously in the pre- and post-authorization phase – from research, development, access and use of medicinal products and the timing of pharmacovigilance and post marketing surveillance.
Expert language translation is critical in facilitating a smooth and efficient pharmacovigilance process. The authorities and contributors have traditionally relied on their on-staff safety officers to manage the translation process, but this is becoming increasingly difficult given the rapid turnaround times required in many situations. Additionally, the translation of adverse event reports requires the understanding of patient confidentiality rules and how they apply to adverse event reports.
In addition, safety officers may or may not understand all of the detailed requirements for patient confidentiality. Patient safety officers also typically have many additional job responsibilities beyond the management of adverse event reports, a factor which can cause delays in getting the reports promptly translated.
With these contributors’ participation in mind, it is often a best practice for pharmaceutical, medical device companies and CROs to work with a qualified LSP who understands the intent and the requirement for a common database with a common medical language. An experienced LSP can help expedite reports and adequately participate in the creation of the worldwide database.
The world of pharmacovigilance is growing in importance every day as medical product manufacturers expand their sales and distribution efforts in the global marketplace. Moreover, the Internet has enabled a growing number of stakeholders including consumers, medical professionals, regulatory agencies and medical product manufacturers to report on and review medically adverse effects of pharmaceutical and medical devices. Inaccurate information or the misinterpretation of reporting information can result in negative outcomes for consumers, manufacturers and the public health community in general. The best approach for the industry, payors and competent authorities to minimize this risk is by establishing standard operating procedures that are built around a philosophy of accuracy, consistency and language transparency.
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