InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 18500 INR.
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GCC drug regulatory affairs

Introduction

Course Type

Course Duration

Feature

Eligibility

Who should attend

Certification

Course Deliverable

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About RA

gcc drug regulatory affairs course

The objective GCC Drug Regulatory Affairs is to impart knowledge of drug regulatory procedures in GCC countries. The course provide detail training on Regulations, Registration procedure, guidelines and dossier preparation specific to GCC countries. Moreover course focus on the regulatory affairs strategic planning for registration of pharmaceutical, biopharmaceutical in GCC countries.

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 Code: RYD-012

Course Title: Advance Certification in GCC Drug Regulatory Affairs

Online distance learning course. Therefore, the course can be accessed online across anywhere 24×7.

1 Month

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 globe.
  • Students can download the course materials from 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 page. 
  • Moreover, final examination is online. Hence student can attend the final examination own convenient date and time. 

Graduation in any discipline. Even the final year student can join the course.

  • Those who want to know about the GCC Pharmaceutical Market, Regulation.
  • One want to enhance knowledge about the GCC countries latest regulatory updates.
  • 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.

 Certificate will be provided at the end of the successful completion of the course.

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also eligible to receive the course study modules. You can download by login to your course page.

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.

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.

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

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 Requirement - Qatar
Lecture 26Drug Registration in Kuwait
Lecture 27Drug Registration in Bahrain
Lecture 28Drug Registration in Oman
Section 3Good Manufacturing Practices Requirement
Lecture 29Introduction to Good Manufacturing Practices
Lecture 30G1 Lecture Premises & Plant Layout Designing
Lecture 31G2 Lecture Sanitation and Hygiene
Lecture 32G3 Lecture Equipment Modules
Lecture 33G4 Lecture Production Modules
Lecture 34G5 Lecture Documentation
Lecture 35G6 Lecture Quality Control
Lecture 36G7 Lecture Product Complaint
Lecture 37G8 Lecture Storage Module
Lecture 38Certification Pharmaceutical Companies / Plants
Section 4Drug Registration Dossier Preparation
Lecture 39Common Technical Document (CTD)
Lecture 40Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 41CMC Dossier & Compliance Management
Lecture 42Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 43Drug Master File
Lecture 44Site Master File
Lecture 45Practical Training on preparing DMF and SMF
Lecture 46Comparison of various regulatory bodies with GCC