TypeOnline Course
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Course Title: KPE’s Certificate Program in Drug Registration and Dossier Preparations.

Course Objective: The objective of this course is to impart knowledge and understanding of Drug Registration and Dossier Preparation.

Course Description

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for different regulatory bodies and practical exposure in drug dossier preparation. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

1. Orientation to practical understanding in the entire drug regulation in brief, drug registration process of different regulatory bodies and practical exposure on Drug Dossier Preparation.

2. Technical Documents and guidelines on dossier preparation

2. Simulation to real life Strategic planning in Drug Registration Process

3. Access to Industry Data bank

4. Attend Live Lectures of all different chapters / study content.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

1 Month

This course is divided into following modules

1. Overview of the Drug Regulation and different regulatory bodies. Basic in-depth Training on regulatory affairs.

2. Drug Registration Process.

3. Drug Dossier and its components.

4. Page by page development of Drug Dossier Preparation.

Detailed page by page CTD preparation included. Course will also provide open file of 154 Page real life CTD (dossier). 

Section 1Introduction
Lecture 1Course Introduction / Download PDF Modules
Lecture 2Pharma Export What? When? and How?
Section 2Dossier Preparation
Lecture 3Common Technical Document (CTD)
Lecture 4Asean Common Technical Document (ACTD) 
Lecture 5CMC Dossier & Compliance Management
Lecture 6Electronic Common Technical Document (ECTD)
Lecture 7Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 8Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 9Importance of effective dossier management
Lecture 10Certificate of Analysis
Lecture 11Detailed Understanding on ANDA Submission Dossier 
Lecture 12Prior Approval Submission 
Lecture 13Detailed Understanding on ANDA Fees
Lecture 14Advance Learning on 505B2 Pathway
Lecture 15Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 16NCE Vs. 505b2 application - Case Based Learning 
Lecture 17FTF - 180 Days Exclusivity - Case Based Learning
Lecture 18Classic case study of the 505b2 filing : Case Based Learning
Lecture 19Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 20
Lecture 21Discussion on 85 common deficiency in CTD submission dossier
Lecture 22Key Consideration for Drug Master File Preparation and Submission 
Lecture 23Practical Understanding on Drug Master File Preparation and Submission
Lecture 24Site Master File - Detailed Understanding 
Lecture 25DMF Completeness Assessment
Lecture 26Drug Master File - Fees
Lecture 27Drug Master File - Global Perspective [Across Different Regions]
Lecture 28Data Integrity issues in Pharmaceutical Industry
Lecture 29Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 30Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 3Drug Registration in Africa
Lecture 31Basic Export Requirement for African Countries
Lecture 32Nigeria  - Drug Registration
Lecture 33Drug Registration in Zambia
Lecture 34Drug Registration in Ghana
Lecture 35Drug Registration in Algeria
Section 4Drug Registration in GCC countries
Lecture 36GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 37Drug Registration in Saudi Arabia
Lecture 38GCC Registration Procedure
Lecture 39Drug Registration in Saudi Arabia
Lecture 40Documentation Required for the GCC countries 
Lecture 41Drug Registration in Oman
Section 5Comparison of Registration Requirement of Different Regulatory Bodies
Section 6Discussions
Lecture 43FAQs
Lecture 44Importance of ISO in export
Section 7Pharma Export Process
Section 8Final Certification Exam