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Reporting adverse drug reactions

BMA Board of ScienceReporting adverse drug reactionsA guide for healthcare professionalsMay 2006improving healthBMA Board of ScienceReporting adverse drug reactions : A guide for healthcare professionalsiReporting adverse drug reactionsA guide for healthcare professionalsMay 2006 Editorial boardA publication from BMA Science & Education department and the BMA Board of ScienceChair, Board of ScienceProfessor Sir Charles GeorgeDirector of Professional ActivitiesProfessor Vivienne NathansonHead of Science & EducationDr Caroline SeddonProject managerNicky JayesingheResearch and writingGemma JacksonEditorial secretariatEeMun ChenNicola FookesDarshna GohilEmily HoyAcknowledgementsThe association is very grateful for the help provided by the BMA committees and many outsideexperts and organisations.

reporting of adverse drug reactions (ADRs) is an important mechanism for post-marketing surveillance of medicines and is vital for maintaining drug safety. In 1996 the BMA’s Board of Science published Reporting adverse drug reactions – a policy document1, which discussed the different structures in place within the UK for reporting ADRs.

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SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

cdsco.gov.in

Duly filled Suspected Adverse Drug Reaction Reporting Form can be send to the nearest Adverse Drug Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC). Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.

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• Discuss how the Common Terminology Criteria for Adverse Events (CTCAE) is used for assessing AEs. • Describe the elements required to document AEs. • Define serious and unexpected AEs and how to report these types of events to various regulatory/oversight groups. • Discuss the purpose and processing of an Investigational New Drug

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REPORTING ADVERSE DRUG REACTIONS DEFINITIONS OF TERMS AND CRITERIA FOR THEIR USE DEFINITIONS OF TERMS AND CRITERIA FOR THEIR USE 1999 1949 TIONAL REPORTING ADVERSE TIONS OF MEDICAL SCIENCES DRUG REACTIONS CIOMS publications may be obtained direct from CIOMS, c/o World Health Organization, Avenue …

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