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An IS0 9001:2015 Certified Institute

Dossier/ANDA Compilation training Program

Dossier/ANDA Compilation training Program

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:-

- THIS COURSE IS DESIGNED TO GAIN IN DEPTH KNOWLEDGE IN REGULATORY AFFAIRS.
- BEING A CMC EXPERT IS THE MAIN OBJECTIVE OF THIS COURSE
- COMMENDABLE KNOWLEDGE IN REGULATORY AFFAIRS
- LIVE PROJECT TRAINING PROGRAM
- HANDS ON EXPERIENCE IN COMPILING THE DOSSIER

Course Syllabus

Topic : 1 Introduction to RA

Topic : 2 ICH guidelines

Topic : 3 CTD – eCTD

Introduction about CTD/eCTD, origin of CTD and detailed knowledge in compiling dossier/ANDA covering scientific guidelines both US & EU market.

Topic : 4 Drug Development Process

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

Topic : 5 Generic Drugs

What are generic drugs, how are they equal with innovator drugs, their development process, dissolution study comparisons and overview on concept of bioequivalence studies.

Topic : 6 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 : 7 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).

Topic : 8 Discussion on deficiencies received from authorities and how to address the quires effectively.

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.

Topic : 9 Current Trends as per agency Expectations

Brief understanding on the current topics, changes in regulatory guidance thus how by meeting the current requirements of Health Authorities.

Topic : 10 Project work with hands on experience in dossier compilation activity

Brief description and extensive discussion about each section in the modules along with project and compilation activity will taught.

Topic : 11 Resume preparation and interview questions

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.

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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