InstructorRoyed Training
TypeOnline Course
Price$290 USD / 13750 INR.
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drug registration and regulation in UAE

Introduction

Course Type

Course Duration

Feature

Eligibility

Who should attend

Certification

Course Deliverable

Related Courses

About RA

UAE drug regulatory affairs training

This drug regulatory affairs course on “Drug Registration and Regulation in UAE” provides deep insight on the marketing authorization process in UAE. The course provide detail training on drug Registration Procedure in United Arab Emirates. It covers recent regulations, registration procedure, country specific Common Technical Documents, guidelines and dossier preparation. Moreover course focus on the regulatory affairs strategic planning for registration of pharmaceutical, biopharmaceutical in United Arab Emirates. UAE drug regulatory affairs

The 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, allowing the user to stop and start at their leisure.

Course Code: RYD-031

Course Title: Advance Certification in Drug Registration & Regulation in UAE.

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

1 Month

This UAE Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the United Arab Emirates 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

  • Orientation to practical understanding in the entire drug regulation, registration procedure of United Arab Emirates. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations.
  • The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
  • Moreover, students can download the course material hand out by login to dashboard. Hence, it helps them to study offline even after completion of the course.
  • Final examination is online. Hence, student can attend the final certification examination at own convenient date and time.

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

  • Freshers and beginners. Those who want to know about the UAE Pharmaceutical Market, Regulation.
  • Drug regulatory affairs professionals. Who want to enhance knowledge about the United Arab Emirates regulatory affairs.
  • 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 UAE.

 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, which you can download by login to your course page.

Few of the similar courses

Career in Drug Regulatory Affairs

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

UAE is the one of the largest, most developed economies in the Middle East. Hence, UAE pharmaceutical market presents significant growth opportunities for local and multinational drug makers. Recent days, expansion of private healthcare coverage and the modernization of health infrastructure will contribute to drive prescription market growth. But stricter pricing controls, generic drug substitution and an unfavorable demographic profile are the few of the challenges of UAE pharmaceutical market. However, there is huge scope for the MNC and domestic pharmaceutical companies.

As we discussed, there are lot of regulatory changes as far as the the drug registration and regulation in UAE. So, the major objective of the regulatory changes to maintain safety and efficacy of the drugs and bio molecules.

In this UAE drug regulatory affairs course, focus is on learning the fundamental to advance learning regarding drug discovery, development to commercialization process. Secondly, course is designed to provide comprehensive training on marketing authorization process for pharmaeutical, biopharmaceutical. Above all, course provide extensive training on drug authorization dossier preparation. In addition, course provide access to case simulations and case studies pertaining to drug registration in United Arab Emirates. Certainly, this help all students to acquire practical understanding regarding marketing authorization process in UAE.

About regulatory affairs job>> Learn here

Section 1Fundamental of Drug Regulatory | Discovery to Commercialization Process
Lecture 1Introduction to Pharmaceutical R&D | Drug Discovery Development Process
Lecture 2Concept of Investigational 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 7USFDA expedited programs
Lecture 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 9Authorized Generics: Key Understanding
Lecture 10Exploratory IND Vs. Traditional IND
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2Clinical Trial | Detail Understanding
Lecture 12Clinical Trials Terminologies 
Lecture 13Clinical Trial Protocol Writing
Lecture 14Ethics in Clinical Research
Lecture 15Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 3Marketing Authorization Process
Lecture 16Introduction: GCC Pharmaceutical Market
Lecture 17GCC Registration Procedure - Centralized and Decentralized Procedure 
Lecture 18Drug Registration in UAE
Section 4Plant Regulatory Affairs
Lecture 19Introduction to Good Manufacturing Practices
Lecture 20G1 Lecture Premises & Plant Layout Designing
Lecture 21G2 Lecture Sanitation and Hygiene
Lecture 22G3 Lecture Equipment Modules
Lecture 23G4 Lecture Production Modules
Lecture 24G5 Lecture Documentation
Lecture 25G6 Lecture Quality Control
Lecture 26G7 Lecture Product Complaint
Lecture 27G8 Lecture Storage Module
Lecture 28Certification Pharmaceutical Companies / Plants
Section 5Submission Dossier Preparation
Lecture 29Chemistry, Manufacturing & Controls 
Lecture 30Introduction to Common Technical Document (CTD)
Lecture 31Advance Practical Training on Dossier Preparation focusing on drug registration
Lecture 32CMC Dossier & Compliance Management
Lecture 33Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 34Drug Master File
Lecture 35Site Master File
Lecture 36Practical Training on preparing DMF and SMF
Lecture 37Comparison of various regulatory guidelines