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 brief description about each section in the modules along with Hands on experience in CTD dossier compilation.
New drug development process, QSAR, pre-clinical and clinical studies, Basics of formulation development, Importance of pre-formulation studies and demonstration of product development with live project
What are generic drugs, how are they equal with innovator drugs, their development process, dissolution study comparisons and overview on concept of bioequivalence studies.
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).
Deficiencies received from various health agencies will be discussed along with best remedial action plan. This programme helps to boost up technical skills and knowledge enhancement.
Insight knowledge in implementation of post approval changes in Europe and US markets. Strategies to define while implementing these changes and submissions.
Resume meeting the latest trends with notified key words will be prepared. Interview questions shall be discussed.
There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
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.