भारतीय भेषज संहिता आयोग
Call for Experts: Join Subject Expert Committee of Materiovigilance Programme of India
Materiovigilance programme of India (MvPI) aims to improve Indian patient safety by monitoring, recording, analysing the root cause of adverse events or risks associated with the use of medical devices including in-vitro diagnostics and suggesting Indian regulatory authority for appropriate action with the sole intention of improving patient safety. Indian Pharmacopoeia Commission (IPC) is an autonomous institution of Ministry of Health & Family Welfare and also functions as the National Coordination Centre (NCC) for MvPI. MvPI receives Medical Device Adverse Events (MDAE) reports from Medical Device Adverse Events Monitoring Centres (MDMCs), Adverse Drug Reactions Monitoring Centres (AMCs), Marketing Authorization Holders (MAHs) and consumers.
Initial examination of the received cases is being done by the MvPI team. After initial examination, MvPI consults with the concerned subject experts based on the device in question and obtains their independent opinion on the received cases. The cases reviewed by the subject experts are further discussed in MvPI partners’ meeting which include the National Health Systems Resource Centre (NHSRC), New Delhi, Sree Chitra Tirunal Institute of Medical Sciences (SCTIMST), Thiruvananthapuram, Central Drugs Standard Control Organization (CDSCO), New Delhi along with concerned subject experts to arrive at a meaningful conclusion on adverse events received at MvPI. Based on the discussion in the MvPI Partners meeting, MvPI issues recommendations to CDSCO for their necessary action at their end and safety alerts to MDMCs and AMCs pan India.
In this connection, MvPI is looking for subject experts in various domains such as interventional Cardiology, Transfusion Medicine, Orthopaedics, ENT, Oncology, Physiotherapy, Forensic Medicine, General Medicine, Gastroenterology, Dental, Gynaecology, Urology, Ophthalmology, Respiratory/Pulmonary, Neurology, Anaesthesiology, Radiology, Endocrinology, Dermatology, Venereology, Biochemistry, Rheumatology, Immunology & Immunogenetics, Pathology, Geriatrics and Pediatrics to provide their opinion on MDAE cases received at NCC-MvPI. Subject experts will be identified based on their active experience and knowledge in the above-mentioned respective fields. The identified subject expert shall provide their opinion on MDAE cases, as and when required either physically or virtually.
An amount of Rs. 4000/-INR as an honorarium per meeting will be provided to the selected subject experts.
Terms of Reference
• Experts must be free of any real, potential, or apparent conflicts of interest.
• NCC-MvPI, IPC has the right to accept or reject the applications of the experts.
• Subject Experts will present their findings to NCC-MvPI, specifically related to their technical assessments of the causality of adverse events, ensuring that the causality evaluation process is accurate and comprehensive.
• Subject experts will adhere to all relevant NCC-MvPI policies, procedures, and guidelines, including those concerning confidentiality, impartiality, and ethical conduct, to ensure the integrity of the causality assessment process for medical device adverse events.
• The subject expert committee will be revised every three years asking about the willingness of the existing subject experts and the requirement for the addition of new experts
Code of Conduct
• An expert shall attend MvPI subject expert meetings as and when required, either physically or virtually.
(Note: A prior intimation for the said meeting will be communicated to the subject experts)
• Maintain strict confidentiality of all the material, knowledge, information, and/or data generated/exchanged with NCC-MvPI.
• Not present themselves as representative of MvPI on any platform other than the official meeting/programs unless nominated by NCC-MvPI.
How to apply
Willing Experts may apply through the below link, the link will be active for 45 days from the date of publication of the advertisement.
