Pharmacovigilance GCC Certification

Onsite | 1 Month | Twice a Year

Course Overview:

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 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.

The “Phar Pharmacovigilance GCC Certification macovigilance 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.

Course Methodology

Our course is designed to equip participants with the real-world skills and knowledge required to be effective Pharmacovigilance 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.
  • One-to-one and group discussions.

Type of Companies Hiring PV Professionals in GCC

  • Pharmaceutical companies and manufacturers.
  • Biologics related sectors.
  • Health authorities.
  • Pharmaceutical consultancy companies.
  • Scientific offices.
  • Marketing authorization holder offices.

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 related to medicine safety and quality required more knowledge about international and local PV guidelines.

Experience: This course doesn't require previous experience in Pharmacovigilance; however, it requires 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?

  • 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 have a better understanding of pharmacovigilance.
  • To gain expertise in the field of PV in tip GCC region.
  • To continue your learning and development in PV related to the GCC.
  • region and be up to date with the guidelines with the guidelines.
  • To have a career growth as PV Officer.
  • To meet, network and share experiences with other industry colleagues.

Upon successful completion of this Course, participants will be awarded with Continuing Professional Development points (CPD) points.

Course Timings

Sessions will start promptly at 9:00 AM and end at 2:00 PM (UAE Time) /Saturday and Sunday of each week

Course Modules
Pharmacovigilance Basics: Introduction to PV and Classification of ADRs.
PV Terminology and Abbreviations
Good Vigilance Practices (GVP)
Medication error
Individual case safety report management
The International Framework for Pharmacovigilance
Causality Assessment
Signal Management System
The Pharmacovigilance System and the pharmacovigilance System Master File
Safety Communication & Aggregated Safety Reporting
Handling Audits and Inspections
Risk Management Measurements & Advertisements
The Role of the MAH & QPPV
PV Regulations and Reporting Systems in the GCC
The Essential Safety Information
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