Professional Certificate Course in Regulatory Affairs

The course is designed for students and industry professionals who need to advance their career as regulatory affairs professionals and stay ahead of the competition.

This course will help participants to develop up-to-date knowledge of regulatory affairs process and legislations especially in the UAE and Gulf region.

o To get a better understanding of important Regulatory Affairs (RA) concepts

o To gain expertise in the field of RA documentation and process in GCC region

o To continue your learning and development in RA field related to GCC region

o To enrich your CV with RA recognised certificate

o To learn how to prepare for an RA related interview

o To meet new Regulatory Affairs experts

o Students who want to pursue their career in regulatory affairs

o Young regulatory professionals who need more knowledge in regulatory affairs

o Industrial personnel who want to change to regulatory affairs career

Duration of course: 3 months

o One or Two taught modules will be delivered by regulatory experts from industries and academia every weekend for 12 weeks

o Participants will be evaluated based on individual module assessments.

Module 1: Regulatory Affairs Introduction & Regulatory Affairs Professionals Role in GCC

Module 2: Pharma Law in UAE and Licensing Requirements

Module 3: Pharmacoeconomics

Module 4: Pharmacoeconomics

Module 5: E-CTD Guidelines

Module 6: Overview on Pharma Registration Requirements in GCC

Module 7: Overview on GSL Registration Requirements in GCC

Module 8: Cosmetic Guidelines in GCC

Module 9: Labeling Guidelines

Module 10: Overview on Medical Device Registration Requirements in GCC

Module 11: Stability Study Related to GCC Region

Module 12: Product Life-Cycle Management

Module 13: Good Manufacturing Practices

Module 14: Pharmacovigilance

Module 15: Communication Skills in Regulatory Affairs & RA Interview

To register or if you have any enquires please contact us