4. The India pharmaceutical industry is expected to grow by 15 per cent per annumbetween 2015 and 2020, outperforming the global industry which is set to grow at 5 percent per annum during the same period. Covers organisational structure, responsibilities, procedures, processes and resources and includes appropriate resource management, compliance management and record management 3. Widing Scope in Pharmacovigilance. • Pharmakon (Greek) = Medicinal Substances • Vigilia (Latin) = To keep watch WHO Definition • The science & activities relating to the detection, assessment, understanding & prevention of adverse effects or any other drug related problems for Healtaficare Candidates Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. 3. Clipping is a handy way to collect important slides you want to go back to later. Excel Healthcare Community Pharmacovigilance in the Elderly - highlights from informal PhVWP June M Raine Pharmacovigilance Working Party. See our Privacy Policy and User Agreement for details. Adverse drug reactions - Classification, mechanism, predisposing factors, casuality assessment [different scales used] c. Reporting, evaluation, monitoring, preventind and management of ADRs d. Role of pharmacist in management of ADR. Looks like you’ve clipped this slide to already. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, and prevention of adverse drug reactions in humans. It basically emphasises on drug responses that are adverse in nature but medical blunders like over dosage, misuse and abuse of a certain drug as well as drug exposure … Since then, it has undergone many changes educationally and These aspects are listed in the guidance document on good pharmacovigilance practices of the Food and Drug Administration (FDA) and include the following 10 : You can change your ad preferences anytime. Statutory Pharmacovigilance inspections by regulatory authorities – especially in the EEA – have become increasingly intensive and wide in scope in recent years. Pharmacovigilance - An overview Tulasi Raman P. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. 6.METHODS OF PHARMACOVIGILANCE Aims and Scope. Pharmacovigilance a. India is one of the largest producers of pharmaceuticals in the world and is popular even for exporting the pharmaceuticals. They work nationally and collaborate internationally to monitor and identify the harm caused by medicines, to reduce the risks to patients and to establish worldwide pharmacovigilance standards and systems. They work nationally and collaborate internationally to monitor and identify the harm caused by medicines, to reduce the risks to patients and to establish worldwide pharmacovigilance standards and systems. Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU. Pharmacovigilance Scope. To develop, manufacture and commercialise a drug a company must adhere to strict regulations. In terms of revenue, branded generics dominate the pharmaceuticals market, constituting nearly 80% o… Unlike the history of medicine, the history of pharmacovigilance is fairly recent. Established Pharmacovigilance System • May wish to restrict what is reported e.g. 1. Scope 126 This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC and Chapter 127 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, Pharmacovigilance Compiled by-Shamon Ahmad, M.Pharma (Q.A) Chandigarh Group of Colleges, Landran, Mohali(Punjab India)email-shmmon@gmail.com on Date-25/12/2012… See our User Agreement and Privacy Policy. Scope, definition and aims of pharmacovigilance b. Pharmacovigilance (PV/PhV) or drug safety can be defined as the pharmacological science that deals with the collection, identification, evaluation, observation and inhibition of the negative effects of various pharmaceutical products. A umque 1nIt1at1ve to 3, Pharmacovigilance has been regarded as a type of continual monitoring of unwanted effects and other safety-related aspects of drugs, which are already placed in markets. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The need for Pharmacovigilance activities continue long after the initial pre-marketing clinical trials, with post-marketing studies forming an important part of the confirmation of the safety and efficacy profile of each new medicinal product. Now customize the name of a clipboard to store your clips. 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