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The GCC Regulatory Affairs (RA) Course is a healthcare certification, which educates young science and pharmaceutical graduates about the latest regulatory affairs, legislation, and documentation in the region.
This course is also aimed at industry professionals who will additionally learn about the complexities of regulatory submissions related to products such as pharmaceuticals, herbal and veterinary medicines,agrochemicals, medical devices, supplements, and cosmetics.
Certified by the Dubai Pharmacy College, our first eight sessions have benefitted those students who wished to enhance their qualifications in regulatory affairs and learn about best practices and standards in the region.
The course could also increase the possibilities of being selected for future jobs openings in the GCC healthcare sector.
Why to join this Course?
Upon Completion of this course , participants should be able to:
Who Should Attend?
Experience / Prerequisite Experience
This course doesn’t require previous experience in regulatory affairs; however, it requires a relevant experience/knowledge and a bachelor’s degree in the pharmaceutical/biological area which qualifies you to benefit from the training. We consider applicants with different background on a case-by-case basis.
Course Modules | |
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Introduction to Regulatory Affairs. | |
Common Technical Document (CTD). | |
Electronic Common Technical Document (E-CTD). | |
Good Manufacturing Practice (GMP). | |
Pharma Registration in GCC. | |
Stability Studies Related to GCC. | |
Labeling Guidelines. | |
Pharmacovigilance. | |
Pricing . | |
Product Life Cycle Management. | |
Pharmacoeconomics. | |
Registration of Medical Device in GCC. | |
Registration of Cosmetics In GCC. | |
General Sales List Pharmaceutical in GCC – General Products (OTC). | |
Overview on Food Beverages Regulatory Affairs (Food and Beverage Registration). | |
Gulf Health Council Registration. | |
VET Medicine Regulation In GCC. | |
Communication Skills in Regulatory Affairs & RA Interview. |