Pharmacovigilance

(Medical Literature Monitoring)

Do I need to monitor medical literature for pharmacovigilance?

One of the primary sources of identifying adverse drug reactions is the monitoring of peer-reviewed medical journals and conference proceedings. An essential aspect of the development and marketing of a drug is determining whether the benefits of the drug outweigh any potential harm. For this reason, governmental authorities such as the Food & Drug Administration (FDA) and the European Medicines Agency (EMA) have placed an obligation on drug companies to monitor the medical literature for any adverse reactions associated with their medicinal products.

What are the requirements for monitoring medical literature?

One of the primary sources of identifying adverse drug reactions is the monitoring of peer-reviewed medical journals and conference proceedings. The FDA requires applicants to report adverse experiences at "quarterly intervals for 3 years from the date of approval of the application, and then at annual intervals." (21 CFR 314.80 - Postmarketing reporting of adverse drug experiences)

The EMA stipulates that companies marketing drugs are expected to conduct systematic literature reviews of "widely used reference databases... no less frequently than once a week." (Module VI - VI.B.1.1.2 Literature Reports)

Why partner with Mc2 for your medical literature monitoring?

  • Databases - Mc2 Research Group has access to the world's leading medical literature databases including Medline, Embase, Biosis, International Pharmaceutical Abstracts (IPA), Elsevier's Scopus, and Chemical Abstracts' STN.

  • Experience - Our researchers have decades of experience in searching these databases and in developing superior search strategies to ensure complete coverage of any adverse effects associated with your drugs.

  • Confidence - Partnering with Mc2 for your medical literature monitoring will provide you with an unbiased, trusted third-party you can count on to meet your information needs.

 

How often should I monitor medical literature for adverse effects?

We recommend a weekly monitor of your regulated products.

 

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