Pharmacovigilance GCC Certification

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Enrolled: 15 students
Lectures: 14

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Pharmacovigilance (PV) is a discipline that 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 careers and strengthen their position in the field of pharmacovigilance.

“Pharmacovigilance GCC Certification” course is designed for students and industry professionals, to advance their careers as PV professionals. 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.

11 -Nov

1
Pharmacovigilance Basics: Introduction to PV and Classification of ADRs.
2
Pharmacovigilance Basics: Introduction to PV and Classification of ADRs.
3
PV Terminology and Abbreviations
4
Good Vigilance Practices (GVP)
5
Good Vigilance Practices (GVP)

12 -Nov

1
The International Framework for Pharmacovigilance.
2
The International Framework for Pharmacovigilance
3
Individual case safety report management
4
Individual case safety report management
5
Medication Errors
6
Medication Errors

18 -Nov

1
Casuality Assessment
2
Causality Assessment
3
Signal Management System
4
Signal Management System

19-Nov

1
The Pharmacovigilance System and the pharmacovigilance System Master File
2
The Pharmacovigilance System and the pharmacovigilance System Master File
3
Safety Communication & Aggregated Safety Reporting
4
Safety Communication & Aggregated Safety Reporting

25 -Nov

1
Handling Audits and Inspections
2
Handling Audits and Inspections

26 -Nov

1
Risk Management Measurements
2
Risk Management Measurements & Advertisements
3
The Role of the MAH & QPPV
4
The Role of the MAH & QPPV
5
PV Regulations and Reporting Systems in the GCC
6
PV Regulations and Reporting Systems in the GCC