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ONCOLOGY DRUG SAFETY & PHARMACOVIGILANCE. An introduction to monitoring, reporting, and managing the safety of cancer therapies.
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CONTENTS. Pharmacovigilance Basics The science of monitoring drug safety 01.
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Define pharmacovigilance Recognize common drug reactions Report and assess adverse events Identify key safety regulations Apply risk management basics.
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What Is Pharmacovigilance?. Definition: the science of detecting, assessing, and preventing harmful effects of medicines. Goal: protect patients before and after a drug reaches the market. In oncology: cancer therapies are powerful, so safety monitoring matters even more..
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Narrow margins: effective doses are often close to toxic doses. Severe side effects: many therapies cause serious, lasting harm. Vulnerable patients: often older, frailer, or on several medications. Long-term risks: some effects can appear months or years later..
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LET'S BEGIN.