About the course:-
This course will provide you with a clear understanding of the US and European regulatory requirements for CTD of your application, and will show you how to compile this important part of your submission dossier. This course will teach you how to Compile and submit CTD of your registration dossier, to ensure that CTD of your dossier contains all data needed, achieve the quickest turnaround for your submission and deal effectively with regulators
Objective of the course:-
Introduction about CTD/eCTD, origin of CTD and detailed knowledge in compiling dossier/ANDA covering scientific guidelines both US & EU market.
New drug development process, QSAR, pre-clinical and clinical studies, Basics 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.
Brief understanding on the current topics, changes in regulatory guidance thus how by meeting the current requirements of Health Authorities.
Brief description and extensive discussion about each section in the modules along with project and compilation activity will taught.
Resume meeting the latest trends with notified key words will be prepared. Interview questions shall be discussed along with mock up interviews to boost the confidence.
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.