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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?
Who Should Attend?
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 | |
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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 |