TypeOnline Course
Student Enrolled2
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Price$390 / Rs. 19500
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drug registration in gcc countries

Introduction

Features

Duration

Course Title: KPE’s Certificate Program in Drug Registration in GCC Countries

Course Objective: The objective of this course is to impart knowledge and understanding of Drug Registration Procedure in GCC countries, Regulations, Registration procedure, country specific Common Technical Documents, GCC guidelines and dossier preparation.

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for the GCC countries. The course is designed to challenge students and Professionals 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 place, allowing the user to stop and start at their leisure.

1. Orientation to practical understanding in the entire drug regulation, registration procedure, country specific common Technical Documents, GCC guidelines and drug dossier preparations.

2. Simulation to real life Strategic planning in Drug Registration in GCC countries.

3. Access to Industry Data bank

4. Access to related Case Studies

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

Upon completion of the admission process, you will be provided the course access. You can attend lectures, case studies and also you can download e-books (modules) from your page. 

1 Month

Course Flow / Syllabus

Section 1Introduction to Drug Regulatory Affairs - Basic Understanding
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug
Lecture 3New Drug Application
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Handling of orange book
Lecture 8Practical Training on INDA, NDA, ANDA filing
Lecture 9Expedited Drug Approval Process
Lecture 10Practical Training on INDA, NDA, ANDA filing
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics
Lecture 13Exploratory IND Vs. Traditional IND
Lecture 14Patents Vs. exclusivity 
Lecture 15Orphan Drug & Orphan Drug Act
Section 2Clinical Trial & Related Terminologies
Lecture 16Clinical Trials Terminologies
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19Informed Consent 
Section 3Introduction to GCC Pharma Market
Section 4GCC Vs. Other Region - Regulatory point of view
Section 5GCC Centralized Vs. Decentralized Registration
Section 6Dossier Preparation
Lecture 23The Common Technical Document (CTD) - Introduction
Lecture 24Dossier Preparation Process for pharma exporting
Lecture 25Stability Study Module 1
Lecture 26Stability Study Test
Lecture 27Interchangeability
Lecture 28Stability Testing of API
Lecture 29Stability Testing of Finished Pharmaceutical Products
Lecture 30Review Test on Stability Testing
Section 7Drug Registration in Saudi Arabia
Section 8Documentation Required for the GCC countries
Section 9Drug Registration Process
Lecture 33Drug Registration in UAE
Lecture 34Drug Registration in Other GCC countries
Lecture 35Requirements of the Drug Registration in the United Arab Emirates
Lecture 36Drug Registration Requirement - Qatar
Lecture 37Drug Registration in Kuwait
Lecture 38Drug Registration in Bahrain
Lecture 39Drug Registration in Oman
Section 10GMP
Lecture 40Definition of GMP
Lecture 41Introduction to Good Manufacturing Practices 
Lecture 42Certification Pharmaceutical Companies / Plants
Lecture 43Premises & Plant Layout Designing
Lecture 44Sanitation and Hygiene
Lecture 45Equipment Modules
Lecture 46Production Modules
Lecture 47Documentation
Lecture 48Quality Control
Lecture 49Product Complaint
Lecture 50Storage Module
Section 11DMF & SMF
Lecture 51DMF & SMF
Lecture 52Site Master File
Lecture 53Practical Training on preparing DMF and SMF
Section 12Exporting to GCC: Requirements and Basic Considerations
Lecture 54Stepwise Procedure for Export
Lecture 55Sequences of activities in pharmaceutical export
Lecture 56Export Documents required
Section 13Comparison of Registration Requirement of Different Regulatory Bodies
Section 14ASSESSMENT OF APPLICATIONS FOR NEW MARKETING AUTHORIZATIONS
Section 15Decision Chart for MA using WHO-Type of Product Certificate
Section 16FAQs : GCC Exporting