The Indian Pharmacopeia Commission (IPC) will organize a National Workshop on ‘Ensuring Quality and Safety of Medical Devices’ from July 19 to 20, 2018 at Ghaziabad, Uttar Pradesh.
Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under the title Indian Pharmacopoeia (IP).
At the Workshop, all health-care stakeholders will be sensitized for a better understanding of medical device standards for promoting patient safety and for the strengthening of materiovigilance system. One can register for the workshop up to July 5, 2018.
IPC has been entrusted with National Coordination Centre responsibilities related to Materiovigilance Programme of India(MvPI) to improve Indian patient safety by monitoring, recording, analyzing the root cause of adverse events or risk associated with the use of medical devices.
MVPI program aims to promote and facilitate adverse event reporting of Medical Devices and subsequently evaluating these events. The scientific and systematic evaluation of these medical device events/reports will foster monitoring trends for improving and protecting the health and safety of patients.
They will also be made aware of the necessity and importance of medical devices adverse events (MDAE) reporting. The objective of the medical devices adverse event reporting is to improve protection of the health and safety of patients, users and others by disseminating information which may reduce the likelihood of, or prevent the repetition of adverse events, or alleviate consequences of such repetition.
This National Workshop will also seek inputs from the industry on an upcoming guidance document on medical devices.
This workshop will help decision making for medical device manufacturers, users, regulators and other stakeholders by disseminating information on how to report, when to report and what to report and what not to report to IPC, NCC-MvPI.
It will also make stakeholders aware of the quality standards for promoting patient safety. It will ensure effective AE reporting culture among MDMCs, clinicians, biomedical engineers, hospital biotechnology staff and other HCPs.
Professionals working in vigilance, quality assurance and regulatory affairs in the medical device industry will attend the workshop.
IPC will also suggest regulatory bodies for appropriate action for improving patient safety.