GUJCOST Sponsored International e-Conference “Regulatory Trends of Biologics and Medical Devices in Covid-19 Pandemic”
The era of newer development and technology has decreased the morbidity and mortality of life. The medical development in terms of drugs and devices has brought about a robust change in the life of the people. Biotechnology provides innovative solutions to the medical field with more than 200 biologic medicines and vaccines. India has emerged as one of the leading providers to the world market for similar biologics. These are considered to become the most important economic and therapeutic element of the pharmaceutical market in India. Recently introduced guidelines and the amendment in the law will provide adequate guidance to both the manufacturers and competent authorities to manage cases efficiently and appropriately.
In the era of newer research and development, technology acts both as a curse and blessing for human beings. Hence, proper and stringent rules and regulations need to be put forth in the practice. Different regulatory bodies exist that regulate or monitor the activities in terms of socio-economic protection of human beings. Looking at the scope and requirements of medical devices, India needs to enter the global market by manufacturing their own devices. Thus, proper rules and regulations are needed to encourage the efficient growth of the device industry. Hence, the proposed conference will provide insights on conditions for approval of biologics and medical devices, Clinical trial Application submission for evaluating safety and efficacy, Post approval changes regarding quality, safety and efficacy document, etc..