Introduction to Pharmacovigilance - MOTEC LIFE-UK

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Yellow Card System • Vital public health mechanism • Essential component in Regulatory Authority’s pharmacovigilance work • To date, more than 500,000 UK reports submitted • www.yellowcard.gov.uk • Reports submitted in confidence by healthcare professionals & patients 6 29th March 2009
Black Triangle Scheme • A black triangle indicates intensive monitoring by the Regulators • Assigned if the drug/vaccine is a new active substance. • Products containing previously licensed active substances may also be monitored: • a new combination of active substances • administration via a new route of administration or drug delivery system • a significant new indication which may alter the established benefit/risk profile of that drug • Assessment is usually made following 2 years of postmarketing experience 7
Page 1 and 2: MotecLife AGM 29 th March 2009 Dr S
Page 3 and 4: Pre Clinical Phase 1 Phase 2 Phase
Page 5: Limitations of Clinical Trials •
Page 9 and 10: Definition of an Adverse Event •
Page 11 and 12: Examples of known ADRs • Teratoge
Page 13: 13 29th March 2009

Introduction to Pharmacovigilance - MOTEC LIFE-UK

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