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.
Read the full article here: http://www.merrillbrink.com/contributors-and-authorities-role-to-facilitate-a-pharmacovigilance-process-08192013.htm.
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Merrill Brink International (http://www.merrillbrink.com) is a leading provider of complete translation and language solutions for global companies and law firms, with special expertise in serving the legal, financial, life sciences, software, heavy machinery and corporate markets. A proven leader with more than 30 years of experience, Merrill Brink offers a wide range of language solutions including translation, localization, desktop publishing and globalization services.
Merrill Brink is recognized in the industry for its commitment to quality and its pioneering approach of leveraging technology to reduce costs, eliminate redundant processes and accelerate translation life cycles. Merrill Brink is certified to ISO 9001:2008; ISO 27001:2005 and ISO 13485:2003, and registered to EN 15038:2006 and ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Merrill Brink International is a wholly owned subsidiary of Merrill Corporation.