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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]
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 ...
The International Society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESOP), is an international non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries.
Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines [ 1 ] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India .
The government on 1 February 2023 appointed Dr. Rajeev Singh Raghuvanshi as Drug Controller General of India. The government earlier on 14 August 2019 appointed Dr. VG Somani as Drug Controller General of India (DCGI). Dr. VG Somani succeeded S Eswara Reddy, the interim DCGI who was appointed in February 2018.
The Pharmacy Council of India (PCI) is the statutory body under the Ministry of Health and Family Welfare, Government of India. It is constituted under the Pharmacy Act of 1948. [1] The Council was first constituted on 4 March 1948. [2] Montubhai Patel was elected as the new president of PCI in May 2022. [3] [4]
With primary objective of identify the earliest possible pharmacovigilance signals, the usage of VigiBase is permitted and accessed by the following authorities: [5] Member states: Authorized centre of all member countries have the free access to the data through VigiSearch/ VigiLyze, or can be requested for data to UMC. Although these data ...