Pharmacovigilance GCC Certification

 

Pharmacovigilance (PV) is a discipline which is mainly concerned with the safety of pharmaceuticals. Due to the increasing need for new drugs, pharmacovigilance is one of the fundamental parts of the product life cycle. That is why the international PV framework of regulations, policies and guidelines are essential to safeguard the public health. In the last few years, GCC countries have strengthened their pharmacovigilance laws and regulations. To market their products in the GCC, pharmaceutical companies will have to comply with both international and national PV requirements. This has created many opportunities for (new) PV professionals to advance their career and strengthen their position in the field of pharmacovigilance.

“Pharmacovigilance GCC Certification” course is designed for students and industry professionals, to advance their career as PV professional. This course will provide attendees with essential knowledge and practices to develop their PV expertise. The attendees will be trained by PV experts within and outside the pharmaceutical industry.

Why to join this Course?

  • To have a better understanding of the pharmacovigilance.
  • To gain expertise in the field of PV in the GCC region.
  • To continue your learning and development in PV related to the GCC region and be UpToDate with the guidelines.
  • To have a career growth as a QPPV or PV Officer.
  • To build up a solid and comprehensive foundation in pharmacovigilance.
  • 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 Attend?

  • Medical background professionals who need more knowledge in the field of Pharmacovigilance.
  • Medical background professionals who need to be a certified PV officer.
  • Pharmacists who want to pursue a career as pharmacovigilance professional.
  • PV officers who are looking for more knowledge in international and local pharmacovigilance.
  • Medical affairs professionals who require more knowledge about PV.
  • Fresh graduates who are looking to start their career in pharmacovigilance.
  • All professions related to medicine safety and quality who required.


Experience / Prerequisite Experience

This course does not require previous experience in Pharmacovigilance; 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 background on a case-by-case basis.

Course Modules
Pharmacovigilance Basics: Historical Overview, Terminology, Definitions and Classification of ADRs..
The International Framework for Pharmacovigilance.
Good Vigilance Practices (GVP)
Global Adverse Events Reporting System and the Individual Case Safety Reports.
Safety Communication & Aggregated Safety Reporting
Signal Management System
The Pharmacovigilance System and Master File
Risk Management Measurement and Advertisements
PV Regulations and Reporting Systems in the GCC
The Role of the MAH & QPPV


Course Structure & Duration:
  • 3 sessions per week (Thursday, Fridays, and Saturday) for (2 weeks).
  • One or Two taught modules will be delivered by the speaker from industries and academia at the Dubai Pharmacy College or online.
  • The course is conducted once a year.
  • Participants will be evaluated based on individual module assessments that will be conducted online.
  • The certificate will be issued one month after the course end.
For more information on the course and registrations, please contact: 04 299 9398, or email info@pra-me.com or visit us on www.pra-edu.com