TypeOnline Course
Price$390 / Rs. 19500
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Admission Process

Admission Process

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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 : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 21DMF & SMF
Lecture 22Site Master File
Lecture 23Practical Training on preparing DMF and SMF
Lecture 24Stepwise Procedure for Export
Lecture 25Importance of effective dossier management
Lecture 26Common Deficiencies in CTD dossier
Lecture 27Boxed Warning
Lecture 28Certificate of Analysis
Section 4Drug Registration in Different ASEAN countries
Lecture 29ASEAN Drug Regulatory Affairs
Lecture 30Asean Geography 
Lecture 31Drug Registration in Brunei 
Lecture 32Drug Registration in Malaysia 
Lecture 33Drug Registration in Cambodia 
Lecture 34Drug Registration in Mayanmar 
Lecture 35Drug Registration in Philippines 
Lecture 36Drug Registration in Singapore 
Section 5Drug Registration in GCC countries
Lecture 37Introduction
Lecture 38Commonly used Business Region Acronyms in Pharmaceutical Industry 
Lecture 39GCC Registration Procedure
Lecture 40Drug Registration in Saudi Arabia
Lecture 41Documentation Required for the GCC countries 
Section 6Comparison of Registration Requirement of Different Regulatory Bodies
Section 7Discussions
Lecture 43FAQs
Lecture 44Importance of ISO in export
Section 8Pharma Export Process