Pharmacovigilance Course

Highlight how drugs like thalidomide (1961), benoxaprofen (1982), and phenformin (1982) were withdrawn after toxic effects, including thalidomide's congenital defects and phocomelia observed in babies.

Define adverse event and adverse drug reaction, explain causal relationships, distinguish side effects from adverse events, and outline unexpected, serious, and severe reactions with the investigator brochure.

Explore the world’s drug regulatory authorities, including India’s central drugs standard control organisation, the FDA, EMEA, MHRA, TGA, and MCC, to prepare for interviews.

Trace the evolution of pharmacovigilance from sulfanilamide and thalidomide disasters to international harmonization, highlighting yellow card, MedWatch, and India pvpi network.

Classify adverse event reports into unsolicited, solicited, contractual agreements, and regulatory authority sources, highlighting unsolicited subtypes such as spontaneous, literature, internet or media reports, and noting stimulated reporting as voluntary.

Identify sources of adverse event reports, including spontaneous, literature, internet, and media, and solicited methods such as clinical trials, post-marketing surveillance, patient use programs, and quality of life questionnaires.

Compare the MedWatch US form and India's susar user form for reporting adverse drug reactions, outlining criteria such as patient information, adverse event, suspected products, and mandatory reporting fields.

Receive case reports from multiple sources, triage and document them, and perform duplicate checks to classify cases as initial or follow-up for accurate archiving.

Identify solicited and unsolicited adverse event reports and understand the six-step ICSR case processing flow—from case receipt, triage, data entry, peer or quality review, medical review, to ICSR completion.

Identify four criteria to deem a pharmacovigilance report valid: identifiable patient, identifiable drug, identifiable reporter, and adverse event. Then perform duplicate search and triage assessing seriousness, expectedness, relatedness, and timelines.

Study how aggregate safety reporting compiles data from spontaneous reports, clinical studies, literature, and health authorities to reveal the drug’s risk-benefit across pre and post marketing.

Write clear patient safety narratives that describe the sequence of adverse events, causality, lab data, treatment, and outcomes within ICH guidelines for pharmacovigilance.

Explain the global standard for narrative writing in pharmacovigilance, detailing the introductory paragraph, body, and conclusion, and outlining data elements like nature, intensity, outcome, timing, labs, concomitant medications, and causality.

Identify and classify elements of an adverse event report in pharmacovigilance, including date of receipt, report type, reporter, demographics, main event, study details, and suspected drug and indication.

Keep follow-up information at the end, treating unconsolidated reports as separate and noting the receipt date for each follow-up item.

Explore five challenges in pharmacovigilance narrative writing, including chronology, medical cohesiveness, vague terms, and relevant laboratory data.

Master drug labeling essentials, including uses, dosages, contraindications, adverse reactions, and handling, while examining reference safety documents such as the investigator brochure, data sheet, local spcs, and patient information leaflets.

Discover how labeling lists common adverse reactions and how to determine expected versus unexpected events using reference standards, severity, duration, and outcome to guide pharmacovigilance reporting.

Identify whether an adverse event is expected or unexpected by comparing severity, specificity, and population context to the label, including cases like fulminant hepatitis, migraine, and overdose.

Explore pharmacovigilance labeling by distinguishing expected from unexpected adverse events, using case-based exercises and justifications for events like anaphylaxis, pneumonia, and tachycardia.

Outline end-to-end pharmacovigilance processes from Excel case processing and triage through data entry, quality review, medical review, ICSR completion, and regulatory submission, covering case seriousness and relatedness.

Explore how pharmacovigilance uses signal detection and signal management to identify unexpected adverse events, validate ICSR reports, and guide risk management through data analysis and labeling.

Learn pharmacovigilance risk management: identify and assess identified and potential risks, and follow the four stages of detection, assessment, minimization, and communication, plus submission of the risk management plan.

Code medical terms, adverse events, medical conditions, and brand-name drugs into a standard language using MedDRA, enabling data standardization and safer signal detection.

Learn MedDRA coding for pharmacovigilance, including auto coding and manual queries, with hierarchical terms from system organ class to lower level term, plus lab data and drug dictionaries.