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drug registration in gcc countries



Course Certification

Course upgrade

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 25Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 26CMC Dossier & Compliance Management
Lecture 27Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 28Importance of effective dossier management
Lecture 29Certificate of Analysis
Lecture 30Discussion on 85 common deficiency in CTD submission dossier
Lecture 31Electronic Common Technical Document (ECTD)
Section 6Drug Registration Process
Lecture 32Drug Registration in UAE
Lecture 33Requirements of the Drug Registration in the United Arab Emirates
Lecture 34Drug Registration Requirement - Qatar
Lecture 35Drug Registration in Kuwait
Lecture 36Drug Registration in Bahrain
Lecture 37Drug Registration in Oman
Lecture 38Drug Registration in Saudi Arabia
Section 7GMP
Lecture 39Definition of GMP
Lecture 40Certification Pharmaceutical Companies / Plants | Introduction to Good Manufacturing Practices 
Lecture 41Premises & Plant Layout Designing
Lecture 42Sanitation and Hygiene
Lecture 43Equipment Modules
Lecture 44Production Modules
Lecture 45Documentation
Lecture 46Quality Control
Lecture 47Product Complaint
Lecture 48Storage Module
Lecture 49Data Integrity issues in Pharmaceutical Industry
Section 8DMF & SMF
Lecture 50DMF & SMF
Lecture 51Site Master File
Lecture 52Practical Training on preparing DMF and SMF
Section 9Exporting to GCC: Requirements and Basic Considerations
Lecture 53Stepwise Procedure for Export
Lecture 54Sequences of activities in pharmaceutical export
Lecture 55Export Documents required
Section 10Reference and Discussions
Lecture 56Comparison of Registration Requirement of Different Regulatory Bodies (GCC vs. US/EU/ASEAN/GCC/LATAM/CIS/Asia Pacific -except ASEAN)
Lecture 57Assessment of application for new marketing authorization
Lecture 58Decision chart for marketing authorizations using WHO-Type product certificate
Lecture 59Some Important Points Regarding GCC Exports 
Lecture 60Documentation Required for the GCC countries 
Section 11Final Certification Examination