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About the course:-
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This training helps to understand drug approval process in major markets US & EU
Objective of the course:-
US(FDA) Introduction, 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.
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.