TypeOnline Course
Student Enrolled2
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Price$390 / Rs. 19500
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Admission Process

Admission Process

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drug registration in gcc countries

Introduction

Features

Course Certification

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Course Code: KPE-C-017

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.

Our Registrants are in Takeda, Pfizer, GSK, Lipoxen (UK), Patheon, Mylan, Biocon, Aurobindo Pharma, Micro Lab, GE Lifesciences, Orchid, Sanofi, AstraZeneca, Hospira, Ranbaxy, Julphar, Jhonson and Jhonson, Ethicon, Dr. Reddy’s Laboratory, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya Herbal Healthcare, Bangalore Pharmaceutical and Research laboratories, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Wintac Limited, Faveo Pharmaceuticals, Enzem, Leo Pharma, Accenture, Shaigan Pharmaceutical, Ceutica & Chemie, Medxplor Healthcare, Systopic Laboratories and many more companies across the pharma industry.

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, 24×7 at your convenience from anywhere across the globe.

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. 

On completion of the course duration course completion certificate will be issued.
On completion of the course final examination, course gradation certificate will be issued.

You can upgrade to 1 Year Advance Diploma in Drug Regulatory Affairs or 1 Year Executive Program in Drug Regulatory Affairs at the end of the course by paying only difference in course fees. For more information regarding upgrade contact info@nckpahrma.com

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 8Complete Response Letter | Key understanding | Management and Action Plan
Lecture 9Expedited Drug Approval Process
Lecture 10505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 11Authorized Generics: Key Understanding
Lecture 12Exploratory IND Vs. Traditional IND
Lecture 13Patents Vs. exclusivity 
Lecture 14Orphan Drug & Orphan Drug Act
Lecture 15Advance Learning on 505B2 Pathway
Lecture 16Chemistry, Manufacturing & Controls 
Lecture 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2Clinical Trial & Related Terminologies
Lecture 18Clinical Trials Terminologies
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 3Introduction to GCC Pharma Market
Section 4GCC Centralized Vs. Decentralized Registration
Section 5Dossier Preparation
Lecture 24The Common Technical Document (CTD) - Introduction
Lecture 25Dossier Preparation Process for pharma exporting
Lecture 26CMC Dossier & Compliance Management
Lecture 27Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Section 6Documentation Required for the GCC countries
Section 7Drug Registration Process
Lecture 29Drug Registration in UAE
Lecture 30Requirements of the Drug Registration in the United Arab Emirates
Lecture 31Drug Registration Requirement - Qatar
Lecture 32Drug Registration in Kuwait
Lecture 33Drug Registration in Bahrain
Lecture 34Drug Registration in Oman
Lecture 35Drug Registration in Saudi Arabia
Section 8GMP
Lecture 36Definition of GMP
Lecture 37Introduction to Good Manufacturing Practices 
Lecture 38Premises & Plant Layout Designing
Lecture 39Sanitation and Hygiene
Lecture 40Equipment Modules
Lecture 41Production Modules
Lecture 42Documentation
Lecture 43Quality Control
Lecture 44Product Complaint
Lecture 45Storage Module
Section 9DMF & SMF
Lecture 46DMF & SMF
Lecture 47Site Master File
Lecture 48Practical Training on preparing DMF and SMF
Section 10Exporting to GCC: Requirements and Basic Considerations
Lecture 49Stepwise Procedure for Export
Lecture 50Sequences of activities in pharmaceutical export
Lecture 51Export Documents required
Section 11Comparison of Registration Requirement of Different Regulatory Bodies
Section 12ASSESSMENT OF APPLICATIONS FOR NEW MARKETING AUTHORIZATIONS
Section 13Decision Chart for MA using WHO-Type of Product Certificate
Section 14FAQs : GCC Exporting
Section 15Final Certification Examination