To sensitize manufacturers, importers, distributors and other stakeholders to develop and strengthen pharmacovigilance system according to the Good Pharmacovigilance Practices (GVP) over the user domain to monitor Adverse Drug Reactions (ADRs) aimed at establishing safer drug use in the country, the Indian Pharmacopeia Commission (IPC) will conduct a workshop on “Basics of Pharmacovigilance and Establishment of Pharmacovigilance System in Pharmaceutical Industries” on March 23 at Metropole, RTO Circle in Ahmedabad.
This will be the fifth regional workshop being organized by the IPC which is aimed to discuss setting up and strengthening of pharmacovigilance system at Market Authorisation Holders (MAHs) site. It will also examine the challenges and current issues for reporting of ADRs by MAHs to the IPC.
The workshop will bring together regulatory authorities and pharma experts and specialists to discuss the practice of pharmacovigilance in the country. It will also widen the knowledge spectrum of pharma experts in the field of pharmacovigilance.
Experts in pharmacovigilance, quality assurance (QA) and regulatory affairs (RA) in pharmaceutical companies and healthcare systems are the targeted audience of this workshop. And the creation of an agreeable roadmap for pharmaceutical companies and healthcare providers for the establishment of a harmonized and sustainable pharmacovigilance system for collection, collation, and processing AEs/ADRs is the expected result of this workshop.
The IPC’s initiative in organizing workshops at different locations in the country is significant as pharmacovigilance enhances patient care and safety in relation to the use of medicines and also play a major role in clinical practice and the development of public health policy.
The Union Health Ministry, therefore, launched a nationwide Pharmacovigilance Program of India (PvPI) in the year 2010 to monitor Adverse Drug Reactions ensuring the benefits of drugs outweighs the risks related to its use.
Indian Pharmacopeia Commission (IPC), the autonomous institute under the ministry has been functioning as National Coordination Center (NCC) for PvPI since April 15, 2011. To ministry ADRs, Adverse Drug Reactions Monitoring Centers (AMCs) under PvPI have been set up the country over.
According to the recent amendment in Drugs and Cosmetic Rules, 1945, Schedule Y and the Gazette notice GSR 287 (E) dated March 8, 2016, the setting up of pharmacovigilance system is mandatory for all MAHs.
In such manner, IPC in collaboration with CDSCO has developed “Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products”, which was released by the ministry on September 29, 2017, and has been effective from January 1, 2018.
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