pharmacovigilance

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Akanksha Narang

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PHARMACOVIGILANCE

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It is the pharmacological science relating to the detection, assesment , understanding & prevention of adverse effects, particularly long term and short term side effects of medicines. Pharmacovigilance starts from the clinical stage and continues throughout the product life cycle of the drug. Mainly divided as: Pre-marketing Post -marketing

PURPOSE OF CLINICAL TRIALS:

PURPOSE OF CLINICAL TRIALS

AIMS OF PHARMACOVIGILANCE:

AIMS OF PHARMACOVIGILANCE

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Improve patient care and safety. Research the efficacy of drug and by monitoring the adverse effects of drugs right from the lab to the pharmacy and then on for many years. Pharmacovigilance keeps track of any drastic effets of drugs.

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Improve public health and safety. Contribute to the assesment of benefit, harm , effectiveness , risk of medicines, encouraging their safe , rationale and more effective (including cost-effective) use. To promote understanding, education and clinical training.

WHY PV IS NEEDED ?:

WHY PV IS NEEDED ?

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Test in animals are insufficient to predict human safety. Patients used in clinical trials are selected and limited in number. Information about rare but serious adverse reactions, use in special groups (such as children, elderly and pregnant women) is often incomplete or not available.

PHARMACOVIGILANCE IN INDIA:

PHARMACOVIGILANCE IN INDIA

Pharmacovigilance Programme of  India (PvPI) for  Assuring Drug Safety Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare Government of India in collaboration with   Indian Pharmacopoeia Commission, Ghaziabad, U.P.     :

Pharmacovigilance Programme of  India ( PvPI ) for  Assuring Drug Safety Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare Government of India in collaboration with   Indian Pharmacopoeia Commission, Ghaziabad, U.P.    

National Pharmacovigilance Program (NPP): Officially inaugurated by the honorable Health Minister Dr. Anbumani Ramadoss on 23 November, 2004 at New Delhi. The Main focus was to collate, analyze and archive adverse drug reaction data for creating healthy environment for the Regulatory Authorities to analyse the drugs to be marketed in India.:

National Pharmacovigilance Program (NPP ): Officially inaugurated by the honorable Health Minister Dr. Anbumani Ramadoss on 23 November, 2004 at New Delhi. The Main focus was to collate, analyze and archive adverse drug reaction data for creating healthy environment for the Regulatory Authorities to analyse the drugs to be marketed in India.

It is a three layered structure consisting of peripheral(28) regional (5) zonal centres(2) Monitored by an apex body i.e. National Pharmacovigilance Advisory Committee and the National Pharmacovigilance Centre ( based at the Central Drugs Standard Control Organization, New Delhi.) :

It is a three layered structure consisting of peripheral(28 ) regional (5 ) zonal centres (2 ) Monitored by an apex body i.e. National Pharmacovigilance Advisory Committee and the National Pharmacovigilance Centre ( based at the Central Drugs Standard Control Organization, New Delhi .)

PROGRESS OF PHARMACOVIGILANCE IN INDIA:

PROGRESS OF PHARMACOVIGILANCE IN INDIA

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WHO HQ + 6 Regional offices WHO Collaborating Centre, Uppsala National Centres

ROLE OF WHO COLLABORATING CENTRE:

ROLE OF WHO COLLABORATING CENTRE Identify early warning signals of serious adverse reactions to medicines. Evaluate the hazard. Undertake the research into the mechanisms of action to aid the develpoment of safer and more effective medicines.

National Centres participating in the Programme August 2008 86 countries: Include Argentina, Ghana, Kenya, Nepal, Netherlands, Nigeria, Russia, Sri Lanka, Tunisia, Uganda, USA :

National Centres participating in the Programme August 2008 86 countries: Include Argentina, Ghana, Kenya, Nepal, Netherlands, Nigeria, Russia, Sri Lanka, Tunisia, Uganda, USA

INTERNATIONAL COOPERATION:

INTERNATIONAL COOPERATION Malaysia WHO Other regulatory agencies Eg ; USFDA

INSTITUTE OFFERING PHARMACOVIGILANCE COURSES:

INSTITUTE OFFERING PHARMACOVIGILANCE COURSES Clinwellkriger training & research institue , Banglore . Bioinformatics institute in India, Noida . Empower school of health,Kalkaji , Delhi. Indian institute of pharmaceutical marketing (IIPM), Lucknow . New York university, New York, USA. Yale university, Chicago, USA.

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