About the course:-
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.
Objective of the course:-
What are ICH guidelines and their importance.
Overview of following ICH guidelines
Introduction about CTD/eCTD, origin of CTD and overview of each module.
US(FDA) Introduction, overview on 21CFR, INDA, NDA, ANDA drug applications, Patents and their types, GDUFA, Post approval changes (Annual reports, CB-30 and prior approval supplements) and Types of DMF’s.
Overview on Drug regulatory authorities in European Union (EU), different types of approval procedures (MRP, DCP, National and Centralized Procedures), brief study on post approval changes (variations and extensions) and approval procedures for drug substance (DMF and CEP).
There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
Live project based on any of the selected use cases on the above selected Domain.
Each class will be followed by practical assignments which can be completed before the next class.
We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
Towards the end of the course, you will be working on a project. Sadhana Infotech certifies you as an course Expert based on the project.