Professional Regulatory Affairs GCC Certification

Onsite | 3 Months | Twice a year

Course Overview:

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 students to develop up-to-date knowledge of regulatory affairs process and legislations especially in UAE and gulf region.

The GCC Regulatory Affairs (RA) Certification 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.

Course Methodology

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 these methods are:

  • Interactive presentations.
  • Group discussions.
  • Case studies.

Course Structure & Duration

  • Modules will be delivered by the expert from the field coming from different industries and academia at the Dubai Pharmacy College
  • Every Sunday morning.
  • The course is conducted twice a year for 3 months.
  • Participants will be evaluated based on individual module assessments that will be conducted online.

Type of Companies Hiring RA Professionals in GCC

  • Pharmaceutical Companies and Manufacturers
  • Medical Device Companies and Manufacturers
  • Biologics and Biotechnology related sectors
  • Veterinary Products Companies and Manufacturers
  • Cosmetic Companies and Manufacturers
  • Health Authorities
  • Pharmaceutical Consultancy Companies
  • Scientific Offices
  • Marketing Authorization Holder Offices
  • Medical Stores
  • Healthcare Logistic Companies
  • Notified Bodies
  • Herbal Companies and Manufacturers

Regulatory Affairs Professional Positions

  • Regulatory Affairs Associates.
  • Regulatory Affairs Assistance.
  • Regulatory Affairs Head / Director.
  • Medical Information Associates.
  • Drug Inspector / Drug Controller / Drug Safety.
  • Specialist/ Regulatory Food.
  • Safety Scientist.
  • Quality Operations / Quality Control / Quality.
  • Assurance.
  • Regulatory Affairs Consultants.
  • Labelling Professional.
  • Public Affairs.
  • Pricing Strategy Expert.

Who Should Attend?

  • Students who want to pursue a career in regulatory affairs.
  • Young regulatory professionals who need more knowledge in regulatory affairs.
  • Professionals 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 relocation or immigration.
  • Regulatory affairs professionals are starting new projects in the GCC.
  • Professionals who want to have an update on the recent healthcare regulations in the GCC market.

Experience & Prerequisite

  • 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/Medical
  • area which qualifies you to benefit from the training.
  • We consider applicants with different backgrounds on a case-by-case basis.

Why 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.
  • Create a thorough understanding of important regulatory concepts.
  • Gain expertise in regulatory affairs documentation and processes.
  • 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’ s regulations.

Course Timings

Sessions will start promptly at 10:00 AM and end at 02:00 PM (UAE Time).

Course Modules
Introduction to Regulatory Affairs.
Common Technical Document (CTD).
Electronic Common Technical Document (E-CTD).
Pharma Registration in GCC.
General Sales List Pharmaceutical in GCC - General Products (OTC).
Overview on Food & Beverages Regulatory Affairs.
Good Manufacturing Practice (GMP).
Stability Studies Related to GCC.
Product Life Cycle Management.
Registration of Medical Device in GCC.
Labeling Guidelines.
Pharmacoeconomics.
Registration of Cosmetics In GCC.
Gulf Health Council Registration.
Pharmacovigilance.
The reimbursement mechanism in the Gulf region.
Pricing.
VET Medicine Regulation In GCC.
Communication and Interview Skill in Regulatory Affairs.
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