Introduction
Feature
Who should attend
Course Content
Related Courses
About Middle East RA
The Middle East pharmaceutical sector is rapidly growing, with countries like Saudi Arabia, the UAE, Egypt, and Jordan becoming hubs for healthcare innovation and investment. As these countries evolve their regulatory frameworks, the demand for skilled regulatory affairs professionals who can navigate complex, country-specific requirements is increasing. This course will help you gain a competitive edge in this dynamic field, whether you’re looking to advance in your current role or begin a new career in regulatory affairs.
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:Â 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.
- Course Certificate: Certificate will be provided at the end of the successful completion of 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
- Harmonization and recent developments in the region – Centralized 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.Â
- Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.Â
Who should attend
- One want to enhance knowledge about the MIDDLE EAST countries latest regulatory updates.
- Regulatory Affairs professionals seeking specialized knowledge in the Middle Eastern market.
- Pharmaceutical and biotechnology industry professionals involved in international expansion.
- Quality Assurance, Quality Control, and Compliance officers working with Middle Eastern companies.
- Healthcare professionals, pharmacists, and researchers aiming to transition into regulatory roles.
- 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.
This comprehensive curriculum is designed to equip students with essential knowledge and skills for a career in regulatory affairs within the Middle Eastern pharmaceutical industry. Here is sneak peek into the course flow:
Introduction to Regulatory Affairs in the Middle East
- Overview of Regulatory Affairs
- Importance and Role of Regulatory Affairs in Pharmaceuticals
- Overview of Middle Eastern Pharmaceutical Markets
- Key Regulatory Authorities in the Middle East (SFDA, MOHAP, etc.)
Middle Eastern Regulatory Frameworks and Compliance Requirements
- Understanding Regulatory Agencies in Each Country (Saudi Arabia, UAE, Egypt, Jordan, etc.)
- Regulatory Requirements and Guidelines by Country
- Key Legislation Governing Pharmaceuticals in the Middle East
- Harmonization Efforts and Common Market Procedures
Product Registration and Licensing in the Middle East
- Product Registration Process for Pharmaceuticals, Biologics, and Medical Devices
- Application Types: New Drug, Generic Drug, Biologics
- Dossier Compilation (CTD and eCTD formats)
- Submission Procedures and Timelines
- Navigating Local Requirements and Variations
Documentation and Technical Writing for Regulatory Submissions
- Overview of Common Technical Document (CTD) Structure
- Module 1 Requirements (Country-Specific Documents)
- Good Documentation Practices
- Labeling and Packaging Requirements
- Key Considerations for Technical Writing in Regulatory Submissions
Clinical and Non-Clinical Data Requirements
- Overview of Preclinical and Clinical Study Requirements
- Bioequivalence Studies in the Middle East
- Clinical Data Submission and Review
- Risk-Benefit Analysis and Evidence Requirements
Quality Requirements in the Middle Eastern Market
- Good Manufacturing Practices (GMP) in Middle Eastern Countries
- Quality Assurance, Quality Control, and Compliance
- Product Stability Testing and Requirements
- Packaging and Storage Requirements
Pharmacovigilance and Post-Marketing Surveillance
- Introduction to Pharmacovigilance
- Adverse Event Reporting Requirements
- Risk Management and Safety Monitoring
- Regulatory Authority Reporting Systems
Variations and Lifecycle Management
- Understanding Types of Variations (Minor, Major)
- Procedures for Variation Submissions
- Change Control Management
- Renewals and Product Lifecycle Management in the Middle East
Case Studies and Practical Applications
- Country-Specific Case Studies (Saudi Arabia, UAE, Egypt, etc.)
- Practical Application: Compiling a Regulatory Dossier
- Review of Past Regulatory Challenges and Solutions
- Workshop: Drafting a Regulatory Submission Plan
Few of the similar courses
- GCC Drug Regulatory Affairs Course
- Drug Regulatory Affairs
- ASEAN drug regulatory affairs
- Latam drug regulatory affairs
- Medical Devices Regulation Training
- Drug Registration and Regulation in UAE
- Drug Registration and Regulation in Saudi Arabia
- European Drug Regulatory Affairs
- Drug Biologics Medical Devices Regulatory Affairs
The Middle East is a transcontinental region in Afro-Eurasia which generally includes Western Asia, all of Egypt, and Turkey. Learn more
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 16 billion on the pharmaceutical industry by 2025. 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. 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.
