Industry Professionals interested in improving their qualifications and advancing their PV Career in the GCC region will find this course especially useful. Taken by PV experts within and beyond the pharmaceutical industry, this course offers updated knowledge and best practices needed to thrive in the PV industry to Pharma professionals.
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?
- Add a qualified certification to your CV and get yourself certified from Dubai Pharmacy College.
- Explore the way to a career growth as a QPPV or PV Officer.
- Gain expertise in the field of PV in the GCC region.
- Build up a solid and a comprehensive foundation in pharmacovigilance.
- Meet, network and share experiences with other industry colleagues.
- Enrich your knowledge and continue your learning and development in PV related to the GCC region and be UpToDate.
Who Should Join?
- 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: 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.
- Pharmacovigilance Basics: Introduction to PV and Classification of ADRs.
- The International Framework for Pharmacovigilance.
- Good Vigilance Practices (GVP)
- Individual Case Safety Report Management
- Safety Communication & Aggregated Safety Reporting.
- Signal Management System
- The Pharmacovigilance System and The Pharmacovigilance System Master File.
- Risk Management System
- PV Regulations and Reporting Systems in the GCC.
- The Role of the MAH & QPPV.
Course Structure & Duration:
- 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 the methods are:
- Interactive presentations
- Individual and team exercises
- One-to-one and group discussions
- Case studies, simulations and small projects