Academics

Professional Certificate Course in Regulatory Affairs

Starting from 3rd March 2017

 

Why to join this Course?

  • 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.
  • To encourage continuous learning and development in regulatory affairs field. 

 

Who should join this Course?

  • 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.
     
Course Modules
Module1: Regulatory Affairs Introduction & Regulatory Affairs Professionals Role in GCC
Module2: Pharma Law in UAE and Licensing Requirements
Module3: CTD Modules Overview
Module4: E-CTD Guidelines
Module5: Overview on Pharma Registration Requirements in GCC
Module6: Stability study related to GCC Region
Module7: Overview on Medical Device Requirement in GCC
Module8: Good Manufacturing Practices
Module9: Pharmacoeconomics
Module10: Pharmacovigilance
Module11: Product Life Cycle Management
Module12: Communication Skills in Regulatory & RA Interview Skills

Course Structure:

Duration of Course: 3 months

  • One or Two taught modules will be delivered by regulatory experts from industries and academia every weekend [Usually on Fridays, 4-6 hours duration] at Dubai Pharmacy College for 12 weeks.
  • Participants will be evaluated based on individual module assessments.
 

For registration and more details please feel free to contact on
04 2999398 or email: info@pra-me.com