InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$690 USD / 34500 INR.
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Middle East Regulatory Affairs course

Introduction

Feature

Who should attend

Certification

Course Deliverable

Related Courses

About Middle East RA

Middle East Pharma Regulation

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

This advance certification course in Middle East Regulatory Affairs covers drug registration, regulation and marketing authorization strategic planning for Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen.

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-066
  • Title of the training: PG Certification in MIDDLE EAST Drug Regulatory Affairs (PGMEDRA)
  • Nature of the course: Online distance learning course. Therefore, the course can be accessed online across anywhere 24×7.
  • Duration of the course: 1 Year.
  • Eligibility of the course: Graduation in any discipline. Even the final year student can join the course.

This MIDDLE EAST Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the MIDDLE EAST 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.

Benefit of Middle East Pharma Regulation Course

  • Gain an overview of the regulatory environment in the Middle East
  • Understand the Economic and cultural background to the Markets
  • Understand the strategic pathway for marketing authorization in middle east countries
  • Harmonisation and recent developments in the region – Centralised registration in the Gulf (GCC-DR), Middle East Regulatory Conference (MERC)

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. 

Who should attend

  • Those who want to know about the MIDDLE EAST Pharmaceutical Market, Regulation.
  • One want to enhance knowledge about the MIDDLE EAST 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 MIDDLE EAST 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.

The Middle East is a transcontinental region in Afro-Eurasia which generally includes Western Asia, all of Egypt, and Turkey. Learn more

Middle East Countries

Middle East usually includes the Arab countries from Egypt east to the Persian Gulf, plus Israel and Iran.

Do Afghanistan is part of middle east?

No. Afghanistan, Pakistan, India, and Bangladesh are usually described as South Asia.

Do Turkey part of middle east?

Yes. Turkey is also part of the Middle East. At the same time due to close proximity of Europe, Turkey sometimes considered as a part of Europe. Middle East includes North Africa as well.

Turkey is a transcontinental country located in both Asia and Europe. 97% of Turkey’s territory lies in Asia and only 3% of its territory lies in Europe.

Middle East Pharmaceutical Market and Regulatory Affairs

The Middle East Region has gradually developed its pharma market and more than 140 companies are operating in the region. Middle East pharmaceutical market accounts approximately 3% of the world market. Middle East pharmaceutical market is semi regulated market. Hence, understanding of regulations and making 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 middle east 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 middle east 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.

Gulf Pharmaceutical Markets

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

The UAE market is valued at $2.2 billion growing by 12% over last year with retail channel being dominant having 79% share growing at 14% previous growth. Alimentary TA accounts for 24% market share growing at 12% PPG generating additional approximately $51mn in 2018. Multinationals dominate the market in sales with Novartis ($210mn) being the leading player however local players like Julphar ($100mn) feature among top 10 and Dar Al Dawa (78% PPG) is the fastest growing corporation.

As we discussed, there are lot of regulatory changes as far as the the drug registration and regulation in middle east 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.

Do the course covers entire course content of GCC Drug Regulatory Affairs?

Yes. All GCC countries marketing authorization process covers in Middle East Regulatory Affairs course.

Do the course cover Egypt drug regulatory affairs?

Yes, absolutely. The course cover the Egypt drug regulatory affairs in detail.

Egypt pharma market is valued at $3.4bn with a growth rate of 26% over last year. Alimentary and anti-infectives are the top selling segments. Novartis is the leading corporation with $267mn sales in 2018 while Medical Union Pharma is the fastest growing corporation experiencing a growth rate of 55% over last year.

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 19Review on Drug Discovery and Development 
Section 2Middle East Pharmaceutical Regulation
Lecture 20Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 21Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 22GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 23Drug Registration and Regulation in Saudi Arabia
Lecture 24Drug Registration and Regulation in UAE
Lecture 25Drug Registration and Regulation in Egypt
Lecture 26Drug Registration and Regulation in Iran
Lecture 27Drug Registration and Regulation in Iraq
Lecture 28Drug Registration and Regulation in Israel
Lecture 29Drug Registration and Regulation in Jordan
Lecture 30Drug Registration and Regulation in Lebanon
Lecture 31Drug Registration and Regulation in Libya
Lecture 32Drug Registration and Regulation in Sudan
Lecture 33Drug Registration and Regulation in Syria
Lecture 34Drug Registration and Regulation in Yemen
Lecture 35Drug Registration in Morocco
Lecture 36Drug Registration Requirements in Algeria
Section 3Good Manufacturing Practices Requirement
Lecture 37Introduction to Good Manufacturing Practices
Lecture 38G1 Lecture Premises & Plant Layout Designing
Lecture 39G2 Lecture Sanitation and Hygiene
Lecture 40G3 Lecture Equipment Modules
Lecture 41G4 Lecture Production Modules
Lecture 42G5 Lecture Documentation
Lecture 43G6 Lecture Quality Control
Lecture 44G7 Lecture Product Complaint
Lecture 45G8 Lecture Storage Module
Lecture 46Introduction 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 47WHO-GMP Certification Scheme 
Lecture 48Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 4Drug Registration Dossier Preparation
Lecture 49Common Technical Document (CTD)
Lecture 50Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 51Chemistry, Manufacturing & Controls 
Lecture 52Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 53ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 54ICH Q2 : Analytical Validation 
Lecture 55ICH Q3 : Impurities
Lecture 56Rest of ICH Q Family Guidelines
Lecture 57CMC Dossier & Compliance Management
Lecture 58Introduction to Electronic Common Technical Document (ECTD)
Lecture 59Key Consideration for Drug Master File Preparation and Submission 
Lecture 60Practical Understanding on Drug Master File Preparation and Submission
Lecture 61Associated Learning: Site Master File - Detailed Understanding 
Lecture 62Drug Master File - Global Perspective [Across Different Regions]
Lecture 63Importance of effective dossier management
Lecture 64Discussion on 85 common deficiencies in CTD submission dossier
Section 5Stability Study
Lecture 65Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 66Climate Zone
Lecture 67Stability Zone Finder
Lecture 68Stability Studies : Case discussions
Lecture 69Stability Data for Zone IV countries
Lecture 70Accelerated and intermediate testing conditions
Lecture 71Long Term Stability Testing Requirements
Lecture 72Stability Study Protocol Development - Dosage form: Capsule
Lecture 73Stability Data Sheet
Lecture 74Stability Testing for dossier submission
Lecture 75Testing Frequency
Lecture 76Bracketing
Lecture 77Matrixing
Section 6Bioequivalence Study | PKPD Study
Lecture 78PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 79Bioequivalence Study | Study design | Different types of BE Studies
Lecture 80Bioequivalence 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 81Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 82Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 83Bioequivalence Study - Discussion - Dissolution Testing
Lecture 84Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 7Variation Management
Lecture 85Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 86Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 87New Updates, Guidelines in Variation
Section 8Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 88Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 89Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 90Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 91Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 92RTQs | Response to Queries | How to handle Regulatory Queries  
Section 9Request for course certification