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

• What is Regulatory Affairs, Importance of RA department, Roles and their functions, and Worldwide regulatory agencies
• General overview of the Pharmaceutical Industry, role of various departments and their functioning.

Topic : 2 ICH guidelines

• What are ICH guidelines and their importance.
• In deep knowledge on ICH guide lines covering Stability Testing of New Drug Substances and Products, Photostability Testing of New Drug Substances and Products, Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Analytical Method Validation, Impurities in New Drug Substances, Impurities in New Drug Products, Guideline for Residual Solvents, Elemental Impurities, Specifications and Pharmaceutical Development.

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.

• Module 1 - Administrative and Prescribing Information
• Module 2 – Common Technical Document Summaries
• Module 3 – Quality Part-CMC
• Module 4 - Nonclinical Study Reports
• Module 5 - Clinical Study Reports

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.