TypeOnline Course
Student Enrolled1
Price$390 / Rs. 19500
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Admission Process

Admission Process

Upon receiving your filled up application form, our admin team will generate PROVISIONAL ADMISSION ID and send you the PROVISIONAL ADMISSION LETTER along with instruction to course fees payment options.

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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 2Fundamentals of Regulatory Affairs
Lecture 3R&D Process & Introduction to drug discovery
Lecture 4Investigational New Drug Application (INDA)
Lecture 5New Drug Application (NDA) 
Lecture 6Basic concept and understanding of the Generic Drug
Lecture 7Abbreviated New Drug Application (ANDA) 
Lecture 8Handling of orange book
Lecture 9Priority Accelerated Review 
Lecture 10Practical Training on INDA, NDA, ANDA filing
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics: Key Understanding
Lecture 13Exploratory IND Vs. Traditional IND
Lecture 14Patents Vs. exclusivity 
Lecture 15Orphan Drug & Orphan Drug Act
Section 3Dossier Preparation
Lecture 16Introduction to Common Technical Document (CTD)
Lecture 17Asean Common Technical Document (ACTD) 
Lecture 18Introduction to Electronic Common Technical Document (ECTD)
Lecture 19Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 20Modules on Stability Study 1
Lecture 21Stability Study Test 
Lecture 22Module on Interchangeability 
Lecture 23Stability Testing of API 
Lecture 24Stability Testing of Finished Pharmaceutical Products
Lecture 25Review Test on Stability Testing 
Lecture 26DMF & SMF
Lecture 27Site Master File
Lecture 28Practical Training on preparing DMF and SMF
Lecture 29Stepwise Procedure for Export
Lecture 30Importance of effective dossier management
Lecture 31Common Deficiencies in CTD dossier
Lecture 32Boxed Warning
Lecture 33Certificate of Analysis
Section 4Drug Registration in Different ASEAN countries
Lecture 34ASEAN Drug Regulatory Affairs
Lecture 35Asean Geography 
Lecture 36Drug Registration in Brunei 
Lecture 37Drug Registration in Malaysia 
Lecture 38Drug Registration in Cambodia 
Lecture 39Drug Registration in Mayanmar 
Lecture 40Drug Registration in Philippines 
Lecture 41Drug Registration in Singapore 
Section 5Drug Registration in GCC countries
Lecture 42Introduction
Lecture 43Commonly used Business Region Acronyms in Pharmaceutical Industry 
Lecture 44GCC Registration Procedure
Lecture 45Drug Registration in Saudi Arabia
Lecture 46Documentation Required for the GCC countries 
Section 6Comparison of Registration Requirement of Different Regulatory Bodies
Section 7Discussions
Lecture 48FAQs
Lecture 49Importance of ISO in export
Section 8Pharma Export Process