eCFR :: 21 CFR 600.80 — Postmarketing reporting of adverse experiences. Title 21 —Food and DrugsChapter I —Food and Drug Administration, Department of Health and Human ServicesSubchapter F —BiologicsPart 600 —Biological Products: GeneralSubpart D —Reporting of Adverse ExperiencesSource: 59 FR 54042, Oct. 27, 1994, unless otherwise noted.Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c,…
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What is Pharmacovigilance aka Drug Safety? Yeah, that is not in the dictionary. Pharmacovigilance (PV) means, Medicine(s) to watch out. Per World Health Organization, it is “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.” Why do Pharmaceutical companies do that ? As…
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Commonly used abbreviations in Pharmaceutical Industry ACRO Academic Research Organization CDMoP Clinical Data Monitoring Plan CRA Contract Research Associate CRO Contract Research Organization CSR Clinical Study Report CTTI Clinical Trials Transformation Initiative DM Data Manager DMon Data Monitoring – All raw and source data review activities by a sponsor that guarantee the protection of trial…
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