In order to enhance the knowledge of qualified pharmacovigilance professionals as per requirement of Schedule Y of Drugs and Cosmetics Act, 1940, the Indian Pharmacopoeia Commission (IPC), which is the national co-ordinating centre (NCC) for the Pharmacovigilance Programme of India (PvPI), is starting a skill development programme for pharmacists, pharmacovigilance (PV) professionals and healthcare professionals across the country.
The programme which is scheduled to start from July 2, 2018 will conclude on July 11, 2018 and will cover states like Chhatisgarh, Karnataka, Andhra Pradesh, Dadra and Nagar Haveli, Lakshadweep and Goa will cover basics and regulatory aspects of pharmacovigilance. It has already covered states like UP, Uttarakhand, Manipur, Chandigarh, Delhi, Madhya Pradesh, Nagaland, Tamil Nadu, Meghalaya, Puducherry and Haryana since January 2018..
This programme will offer adequate knowledge to to the participants to secure employment opportunities in the emerging field of pharamacovigilance. It will also ensure capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPV) as per recent amendments in Drugs and Cosmetics Rules, 1945.
Pharmaceutical industries play an important role for patient safety by collecting Adverse Drugs Reactions (ADRs) due to the use of pharmaceutical products and sending them to the IPC - NCC- PvPI.
As per the recent amendment to Schedule Y, Drugs and Cosmetics Rules, 1945, notified through Gazette Notification on March 8, 2016, PV has been made mandatory for Marketing Authorization Holders (MAHs) in India. In order to ensure the effective implementation there is need to understand the issues and challenges for the MAHs as well as PvPI in terms of managing ADRs and to set up a pharmacovigilance system at MAHs’ organisation
Target participants are professionals in PV, quality assurance (QA) and regulatory affairs (RA) in pharmaceutical industry and healthcare systems.
This will also help obtain information about requirements to set up and strengthen the pharmacovigilance system. It will help get information to improve the PV system in compliance with the regulatory requirements.
This will also help get information about quality management system at MAHs’site and any other issues related to pharmaceutical industries for reporting of ADRs to IPC, NCC-PvPI.