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Professional Regulatory Affairs GCC Certification

Summary

The course is designed for students and industry professionals who need to advance their career as regulatory affairs professional and stay ahead of the competition. This course will help students to develop up-to-date knowledge of regulatory affairs process and legislations especially in UAE and gulf region.

Why To Join?

  • To build up a solid and comprehensive foundation in regulatory affairs.
  • To create a thorough understanding of important regulatory concepts.
  • To gain expertise in the field of regulatory affairs documentation and process in the GCC.
  • To encourage continuous learning and development in regulatory affairs field.
  • To get certified from Dubai Pharmacy college.
  • To add a qualified certification to your CV.
  • To meet, network and share experiences with other industry colleagues.

Who Should Join?

  • Students who want to pursue their career in regulatory affairs.
  • Young regulatory professionals who need more knowledge in regulatory affairs.
  • Industrial personnel who want to change 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.

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
  • Licensing Requirements for Pharma Entities in UAE
  • Pharmacoeconomics
  • Common Technical Document (CTD)
  • Electronic Common Technical Document (E-CTD)
  • Pharma Registration in GCC
  • General sales list pharmaceuticals in GCC
  • Registration of cosmetics in GCC
  • Labeling Guidelines
  • Registration Of Medical Device in GCC
  • Stability Study Related to GCC Region
  • Product Life Cycle Management
  • Good Manufacturing Practice (GMP)
  • Pharmacovigilance
  • Communication Skills in Regulatory Affairs & RA Interview

Course Structure & Duration:

  • Our course is designed to equip participants with the real-world skills and knowledge required to be effective Regulatory Affairs professional. Our course relies on a variety of training and facilitation methodologies and techniques used whenever applicable; these methods aim to enhance participant interaction while maximizing the learning journey.

Some of the methods are:

  • Interactive presentations
  • Individual and team exercises
  • One-to-one and group discussions
  • Case studies, simulations and small projects