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An IS0 9001:2015 Certified Institute

Drug Approval procedure in US and EU

Drug Approval procedure in US and EU

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:-

THIS COURSE IS BEST TO GAIN KNOWLEDGE IN REGULATORY FILINGS IN US & EU MARKETS

Course Syllabus

Topic : 1 Introduction to RA

Topic : 2 Drug Approval procedure in US

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.

Topic : 3 Drug Approval procedure in Europe.

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).

Course Features

Instructor Live Sessions

There will be allocated hours of instructor with Live classroom and Simultaneously on Online.

Real Time Studies

Live project based on any of the selected use cases on the above selected Domain.

Assignments

Each class will be followed by practical assignments which can be completed before the next class.

24/7 Support

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.

Certification

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.

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