InstructorRoyed Training
TypeOnline Course
Student Enrolled3
Price$490 USD / 27500 INR.
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gcc drug regulatory affairs course



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gcc drug regulatory affairs course

The objective GCC Drug Regulatory Affairs is to impart knowledge of drug regulatory procedures in GCC countries. The course provides detailed training on Regulations, Registration procedure, guidelines and dossier preparation specific to GCC countries. Moreover the course focuses on the regulatory affairs strategic planning for registration of pharmaceutical, biopharmaceuticals in GCC countries. Above all, the course provides marketing authorization variation training for GCC countries. Hence, this course provides comprehensive 360 degree training that regulatory professionals need to deal with in specific.

In addition, this course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place. So, it allows the user to stop and start at their leisure.

Course Snapshot

  • Course Code: RYD-012
  • Title of the course: Advance Certification in GCC Drug Regulatory Affairs (ACGDRA)
  • Course Duration: 1 Month
  • Nature of the course: Online distance learning course. Therefore, the course can be accessed online across anywhere 24×7.
  • Eligibility: Graduation in any discipline. Even the final year student can join the course.
  • Course Certification: Certificate will be provided at the end of the successful completion of the course.

This GCC Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the GCC pharmaceutical market. This online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.

Key features of the course

  • 24×7 Online Access. Therefore, access the course anytime from anywhere across the globe.
  • Students can download the course materials from the dashboard. Hence, it helps them to study offline even after completion of the course.
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web pages.
  • Moreover, the final examination is online. Hence students can attend the final examination at their own convenient date and time.

Who should attend GCC Regulatory Affairs course?

  • Those who want to know about the GCC Pharmaceutical Market, Regulation.
  • One want to enhance knowledge about the GCC countries latest regulatory updates on pharmaceutical and biopharmaceutical industry.
  • Business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the pharmaceuticals in GCC countries.

Career in GCC Drug Regulatory Affairs

A career in Regulatory Affairs is very challenging. But at the same time regulatory affairs career can be highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

GCC pharmaceutical market

The pharmaceutical market in the Gulf Cooperation Council (GCC) has witnessed considerable progress over the years due to favorable demographic and economic factors. Above all, there is a strong support from the government  for healthcare industry. Despite the progress, the pharmaceutical sector in the Gulf is still in an emerging phase. It is not highly regulated market. But drug regulation in GCC countries are evolving very fast. A vast majority of pharmaceuticals consumed in the region are of imported brand. However, the governments have been trying to increase local drug manufacturing. In turn, it will reduce reliance on imported products.

Largest pharmaceutical market among GCC countries

The Gulf countries are expected to spend USD 12 billion on the pharmaceutical industry by 2020. Among GCC countries,  Saudi Arabia has the largest market for pharmaceuticals.

As we discussed, there are lot of regulatory changes as far as the the drug registration and regulation in GCC countries. So, the major objective of the regulatory changes to maintain safety and efficacy of the drugs and bio molecules. The regulatory reform had taken place keeping easy of marketing authorization. Above all, this reform will help to align the regulatory pathway with developed market like US and EU. Hence, this will be easier and easily manageable.

About regulatory affairs job>> Learn here

About China Drug Regulatory Agency >> Learn more

Do the course provide marketing authorization training specific to different GCC countries?


Can course GCC regulatory affairs duration be extended?

In general, this course is having duration of 1 month. But you can increase your course subscription period of your need. What we mean, if you require to increase the course duration for 2 month or 3 month, you can do so. Kindly keep in touch our support team at, they will assist you further.

Is dossier preparation training included?

Yes. Dossier preparation is important job for regulatory professionals. This course provides in-depth training on dossier preparation.

Section 1Drug Discovery Development to Commercialization Regulation
Lecture 1Introduction to Pharmaceutical R&D | Drug Discovery Development Process
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Handling of orange book
Lecture 7Complete Response Letter | Key understanding | Management and Action Plan
Lecture 8USFDA expedited programs
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Orphan Drug Designation 
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14Chemistry, Manufacturing & Controls 
Lecture 15Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 16Clinical Trials : Advance Understanding |
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 20Review on Drug Discovery and Development 
Section 2GCC Pharmaceutical Regulation
Lecture 21Introduction: GCC Pharmaceutical Market
Lecture 22GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 23Drug Registration in Saudi Arabia
Lecture 24Drug Registration in UAE
Lecture 25Drug Registration in Kuwait
Lecture 26Drug Registration in Bahrain
Lecture 27Drug Registration in Oman
Section 3Good Manufacturing Practices Requirement
Lecture 28Certification Pharmaceutical Companies / Plants
Lecture 29G1 Lecture Premises & Plant Layout Designing
Lecture 30G2 Lecture Sanitation and Hygiene
Lecture 31G3 Lecture Equipment Modules
Lecture 32G4 Lecture Production Modules
Lecture 33G5 Lecture Documentation
Lecture 34G6 Lecture Quality Control
Lecture 35G7 Lecture Product Complaint
Lecture 36G8 Lecture Storage Module
Lecture 37Certification Pharmaceutical Companies / Plants
Lecture 38Pharmaceutical SOPs Management from regulatory perspective
Lecture 39Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 40PDE Value | Importance, Significance | How to calculate PDE value 
Lecture 41Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 42WHO-GMP Certification Scheme 
Lecture 43Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 4Drug Registration Dossier Preparation
Lecture 44Common Technical Document (CTD)
Lecture 45CMC Dossier & Compliance Management
Lecture 46Introduction to Electronic Common Technical Document (ECTD)
Lecture 47Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 48Importance of effective dossier management
Lecture 49Discussion on 85 common deficiencies in CTD submission dossier
Lecture 50Certificate of Analysis
Section 5Drug Master File | Site Master File
Lecture 51Key Consideration for Drug Master File Preparation and Submission 
Lecture 52Practical Training on preparing DMF and SMF
Lecture 53Site Master File
Lecture 54DMF Completeness Assessment
Lecture 55Drug Master File - Fees
Lecture 56Drug Master File - Global Perspective [Across Different Regions]
Section 6Stability Study
Lecture 57Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 58Climatic Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 59Stability Zone Finder
Lecture 60Stability Studies : Case discussions
Lecture 61Case Study: Managing Stability Study for Zone IV countries
Lecture 62Accelerated and intermediate testing conditions
Lecture 63Long Term Stability Testing Requirements
Lecture 64Stability Study Protocol Development - Dosage form: Capsule
Lecture 65Stability Data Sheet
Lecture 66Dossier Stability Test
Lecture 67Testing Frequency
Lecture 68Bracketing
Lecture 69Matrixing
Section 7Bioequivalence Study
Lecture 70PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 71Bioequivalence Study | Study design | Different types of BE Studies
Lecture 72Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 73Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 74Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 75Bioequivalence Study - Discussion - Dissolution Testing
Lecture 76Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 8Variation Management
Lecture 77Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 78Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Section 9Comparison of GCC requirements with other regions
Section 10Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 80Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 81Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 82Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 83RTQs | Response to Queries | How to handle Regulatory Queries