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The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic. [3] The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems. [3] One of the successes of the program was detecting adverse effects of people in India using carbamazepine.
The Society of Pharmacovigilance, India (SoPI), is an Indian national non-profit scientific organisation, which aims at organizing training programmes and providing expertise in pharmacovigilance and enhance all aspects of the safe and proper use of medicines [1]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO). Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of ...
Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some countries consumers) to identify and report any adverse events to their national pharmacovigilance center, health authority (such as the European Medicines Agency or FDA), or to the drug manufacturer ...
Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance centres in regard to the benefits, harm, effectiveness and ...
Institute of Chartered Accountants of India: 1-May-1949: Financial system and monetary policy: Reserve Bank of India: 01-Apr-1935: Mining and Mineral Exploration: Directorate General of Mines Safety(DGMS) 07-Jan-1902: Food Safety: Food Safety and Standards Authority of India: Aug-2011: Security Market: Securities and Exchange Board of India: 12 ...
The DMC will convene at predetermined intervals (depending on the type of study) to review unblinded results. The DMC has the power to recommend continuation or termination of the study based on the evaluation of these results.