Introduction
Course Type
Course Duration
Feature
Eligibility
Who should attend
Certification
Course Deliverable
Related Courses
About Middle East RA
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 Code: RYD-066
Course Title:Â Advance Certification in MIDDLE EAST Drug Regulatory Affairs (ACMEDRA)
Online distance learning course. Therefore, the course can be accessed online across anywhere 24×7.
1 Month
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.Â
- Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.Â
Graduation in any discipline. Even the final year student can join the course.
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.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules. You can download by login to your course page.
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 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.
