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Pharmacovigilance @ Transintegra

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Pharmacovigilance is an ongoing process requiring systematic safety monitoring to identify previously identified and unidentified adverse drug reactions and to evaluate the safety and efficacy of medical products during clinical trials and subsequent to marketing of the product.

Marketing Authorization Holders are the ‘owner’ of product and are primarily responsible for ensuring that the objectives for pharmacovigilance are fulfilled.

Risk of Non-Compliance

In most countries the MAH responsibility is described within the law. Failure of Pharmacovigilance Compliance can lead to Regulatory Warning, Suspension of Licence or Product Recall.

As a marketing authorization holder, you shouldn't face a warning letter or recall. Although procedures can vary depending on the regulatory agency, the most common observation of non-compliance are:

  • Failure to report each adverse drug experience
  • Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting  of post marketing adverse drug experiences from all sources
  • Failure to submit adverse drug experiences reports that are both serious and unexpected within the time-frame defined by regulatory agency

prevent the risk

Why wait, when the business risks can be eliminated without hiring/training additional staff on urgent business priorities. 

TRANSINTEGRA will solve your Pharmacovigilance problems by proper assessment of risks & implementation of the Pharmacovigilance requirements, including some of the urgent PSUR’s commitments & updates.