Merrill Brink News Reviews and Opinions: Improvement of pharmacovigilance to reduce adverse drug reactions

Share Article -- EU companies and applicants for market authorisations are now responsible to monitor the safety of the medicines throughout its lifespan.

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Pharmacovigilance and risk management plans for medicines will only be truly efficient if they are consistently understood by all stakeholders.

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Are you a regulatory professional in the pharmaceutical, medical device or life sciences industry? Are you aware of the changes in the European Union (EU) pharmacovigilance?

EU companies and applicants for market authorisations are now responsible to monitor the safety of the medicines throughout its lifespan. The legislation is in place to protect the public safety, and businesses need to comply or risk facing serious dissuasive and financial penalties.

Pharmacovigilance compliance requires transparency from stakeholders and regulatory professionals throughout the EU’s 27 member states. Pharmacovigilance deals mainly on adverse drug reactions (ADRs) and its risk management process. Given that the EU has 23 national languages, and have other beneficiaries, an organisation involved in pharmacovigilance needs to be prepared that ADRs and other related documents may come in many languages.

When preparing to meet pharmacovigilance regulation you should assess whether or not a qualified language services provider (LSP) can assist you:

  •     Help detect, reduce duplication and eliminate duplicative process
  •     Translate any or all documents across multiple languages
  •     Proven translation process that meets regulatory obligations

To learn more about pharmacovigilance and the role of translations in ensuring the integrity of the process, find out more from this article

About Merrill Brink International
Merrill Brink International ( 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, localisation, desktop publishing and globalisation services.

Merrill Brink is recognised 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.

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Vanessa Lontoc
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