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Pharmacovigilance GCC Certification

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Enrolled: 2 students
Duration: 3 weeks
Lectures: 14
Level: Beginner

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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.

12-Nov

1
Pharmacovigilance Basics: Introduction to PV and Classification of ADRs.
180
2
Pharmacovigilance Basics: Introduction to PV and Classification of ADRs.
11 questions
3
PV Terminology and Abbreviations
70

13-Nov

1
Individual case safety report management
120
2
Individual case safety report management
10 questions

19-Nov

1
Causality Assessment
180
2
Causality Assessment
10 questions
3
Signal Management System
180
4
Signal Management System
10 questions

20-Nov

1
The Pharmacovigilance System and the pharmacovigilance System Master File
180
2
The Pharmacovigilance System and the pharmacovigilance System Master File
10 questions
3
Safety Communication & Aggregated Safety Reporting
180
4
Safety Communication & Aggregated Safety Reporting
10 questions

26-Nov

1
Handling Audits and Inspections
180
2
Handling Audits and Inspections
10 questions
3
The International Framework for Pharmacovigilance.
120
4
The International Framework for Pharmacovigilance.
10 questions

27-Nov

1
Risk Management Measurements
120
2
Risk Management Measurements & Advertisements
10 questions
3
The Role of the MAH / PV Regulations
120
4
The Role of the MAH & QPPV
10 questions
5
PV Regulations and Reporting Systems in the GCC
120
6
PV Regulations and Reporting Systems in the GCC
10 questions

10-Dec

1
Good Vigilance Practices (GVP)
120
2
Good Vigilance Practices (GVP)
10 questions
3
Medication Errors
120
4
Medication Errors
10 questions