Who should attend
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.
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.
- 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.
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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.
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