Pharmacovigilance GCC Certification
Course Starting on 3rd Feb 2022
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.
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 is looking for more knowledge in international and local pharmacovigilance.
- Medical affairs professionals who require more knowledge about PV.
- Fresh graduates who is looking to start their career in pharmacovigilance.
- All professions related to medicine safety and quality who required more knowledge about.
- International and local PV guidelines
Experience / Prerequisite Experience
This course doesn't 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: Introduction to PV and Classification of ADRs. | |
| PV Terminology and Abbreviations | |
| Individual case safety report management | |
| Good Vigilance Practices (GVP) | |
| Medication Errors | |
| Signal Management System | |
| Safety Communication & Aggregated Safety Reporting | |
| The Pharmacovigilance System and the pharmacovigilance System Master File | |
| Handling Audits and Inspections | |
| Causality Assessment | |
| The International Framework for Pharmacovigilance. | |
| Risk Management Measurements & 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.