TypeOnline Course
Student Enrolled1
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Price$390 / Rs. 19500
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drug registration in gcc countries

Introduction

Features

Duration

Course Fees

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

330 USD (For payment outside India.)

16500 Indian Rupees (For payment within India)

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 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10Practical Training on INDA, NDA, ANDA filing
Lecture 11Priority Accelerated Review
Section 2Clinical Trial & Related Terminologies
Lecture 12Clinical Trials Terminologies
Lecture 13Clinical Trial Protocol Writing
Lecture 14Ethics in Clinical Research
Lecture 15Informed 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 19The Common Technical Document (CTD) - Introduction
Lecture 20Dossier Preparation Process for pharma exporting
Lecture 21Stability Study Module 1
Lecture 22Stability Study Test
Lecture 23Interchangeability
Lecture 24Stability Testing of API
Lecture 25Stability Testing of Finished Pharmaceutical Products
Lecture 26Review Test on Stability Testing
Section 7Drug Registration in Saudi Arabia
Section 8Documentation Required for the GCC countries
Section 9Drug Registration Process
Lecture 29Drug Registration in UAE
Lecture 30Drug Registration in Other GCC countries
Lecture 31Requirements of the Drug Registration in the United Arab Emirates
Lecture 32Drug Registration Requirement - Qatar
Section 10Fundamental of Medical Devices Regulation
Lecture 33Fundamentals of Medical Devices
Lecture 34Overview of Medical Devices Regulation
Lecture 35Medical Devices: Guidance, Classification and Guidance, CE Marking
Section 11Medical Device Registration in GCC countries
Section 12GMP
Lecture 37Definition of GMP
Lecture 38Introduction to Good Manufacturing Practices 
Lecture 39Certification Pharmaceutical Companies / Plants
Lecture 40Premises & Plant Layout Designing
Lecture 41Sanitation and Hygiene
Lecture 42Equipment Modules
Lecture 43Production Modules
Lecture 44Documentation
Lecture 45Quality Control
Lecture 46Product Complaint
Lecture 47Storage Module
Section 13DMF & SMF
Lecture 48DMF & SMF
Lecture 49Site Master File
Lecture 50Practical Training on preparing DMF and SMF
Section 14Exporting to GCC: Requirements and Basic Considerations
Lecture 51Stepwise Procedure for Export
Lecture 52Sequences of activities in pharmaceutical export
Lecture 53Export Documents required
Section 15Comparison of Registration Requirement of Different Regulatory Bodies
Section 16ASSESSMENT OF APPLICATIONS FOR NEW MARKETING AUTHORIZATIONS
Section 17Decision Chart for MA using WHO-Type of Product Certificate
Section 18FAQs : GCC Exporting