Lecture 2 - Pharmacovigilance in Animal Health Regulatory...

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1 1 Pharmacovigilance in Animal Health Regulatory Affairs Graduate Education Program UGA Kari Blaho-Owens 2 1. Pharmacovigilance 2. Adverse events 3. Laws and regulations 4. Post marketing adverse event data 5. Additional resources Contents
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2 3 Pharmacovigilance Pharmakon (greek) – “drug” Vigilare (latin) – to keep awake or alert, to keep watch Is a system that defines, implements and maintains the processes for collecting, analyzing, and reporting post-marketing adverse event (AE) data Post market surveillance of spontaneously reported AE data is one component in the overall monitoring of a drug’s safety and efficacy. This system is an integral part of the veterinary product (drug, vaccine) life-cycle process. The overall goal of pharmacovigilance is to foster the rational and safe use of medicines. 4 Pharmacovigilance (PV) Elements of Hippocratic medicine (Veterinary Medicine, An Illustrated History, Dunlop, Williams Mosby) – Clinical evaluations using all senses and problem-oriented diagnosis – Cosmological and ecological factors, hygiene and expected time course – Recording of data and commitment to advance the knowledge of disease – Moral commitment to and humanistic concern for the patient – Mastery of medicine, with required apprenticeship with a Master – Avoidance of recourse to mysticism while providing psychological support
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3 5 Pharmacovigilance Hippocratic approach derives from an evolving scientific perspective: a base of accumulated and redistilled knowledge of the course, treatment and outcome of clinical cases; rigorous examination and data gathering; and analysis and decision making leading to intervention for the safety and comfort of the patient 6 Adverse Event VICH GL 24, III.1 – Management of Adverse Event Reports defines an adverse event as any observation in animals, whether or not considered to be product-related, that is unfavorable and unintended and that occurs after any use of VMP (veterinary medicinal product) (off-label or on-label use). Included are events related to a suspected lack of expected efficacy according to approved labeling or noxious reactions in humans after being exposed to VMP(s). CVMP, Guideline on Pharmacovigilance for veterinary medicinal products – guidance on procedures for marketing authorization holders. EMEA/CVMP/183/96 – Rev. 1 Consultation, section 4 defines an AE or adverse reaction as a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function. FDA 21CFR Part 514.3(a) – defines an adverse event is any adverse event associated with the use of a new animal drug, whether or not considered to be drug related, and whether or not the new animal drug was used in accordance with the approved labeling. Adverse drug experience includes, but is not limited to:
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This note was uploaded on 01/01/2012 for the course PHRM 7230 taught by Professor Tackett during the Spring '11 term at University of Georgia Athens.

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Lecture 2 - Pharmacovigilance in Animal Health Regulatory...

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