Professional Regulatory Affairs GCC Certification

 

Course start dates – to be announced

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:

     
  • Build up a solid and comprehensive foundation in regulatory affairs.
  • Understand the procedures of company, manufacturer, and product registration according to the product category.
  • Create a thorough understanding of important regulatory concepts.
  • Gain expertise in the field of regulatory affairs documentation and process.
  • Encourage continuous learning and development in regulatory affairs field.
  • Get certified from Dubai Pharmacy college.
  • Add a qualified certification to their CVS.
  • know more about GCC health authorities’ regulations.


Who Should Attend?

  • Students who want to pursue their career in regulatory affairs.
  • Young regulatory professionals who need more knowledge in regulatory affairs.
  • Professional personnel who want to shift their career to regulatory affairs career.
  • Regulatory Affairs Professionals who need to be certified by a recognized college.
  • Personal who needs RA certification for the purpose of relocation or immigration.
  • Regulatory affairs professionals starting new projects in the GCC.
  • Professionals who want to have an update on the recent healthcare regulations in the GCC market.


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
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.


Course Structure & Duration:
  • One or Two taught modules will be delivered by the speaker from industries and academia.
  • Participants will be evaluated based on individual modules assessments that will be conducted online.
  • The certificate will be issued one month after the course end.
  • Course is available online.
For more information on the course and registrations, please contact: +971 4 299 9398/ +971 4 255 5728 or email training@pra-me.com or visit us on www.pra-me.com