This is a 5-day training programme which spans over five half-days (3 hrs per day).
Attending the full 5 days is mandatory.

Fee: from $100.00 per person

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you.

Drug Safety is a primary concern throughout the life-cycle of any medicinal product. Pharmacovigilance (PV) activities are crucial for improvement of patient care, public health, and safety in relation to the use of medicines. PV is becoming a career opportunity that requires certain skills, training, and experiences.

The training course is designed to use a blended learning approach where you will have a mixture of lectures, interactive discussions, workshops, and progress check quizzes to keep your learning experience enjoyable and memorable.

Featured Topics:

• Background and History of Pharmacovigilance
• Legislation and regulatory framework
• Journey of Adverse Events and Causality Management
• Risk Management System
• Periodic Aggregate Reports (PSUR / PBRER)
• PV System Files: PSMF, PSSF
• Role of QPPV / LSR

12.00 pm – 15.00 pm (London, UK)

What you will learn:

• Understand the History behind the evolution of the PV and the key definitions.
• Understand the Legislation and regulatory framework globally and in the region.
• Understand the Journey of Adverse Events as individual cases and within the various types of safety reports.
• Understand the Risk Management System including the plan, the minimization measures and how to measure the effectiveness.
• Understand the concepts of the Periodic Aggregate Reports.
• Understand the details & contents of the various PV files (preparation, maintenance, updates)
• Understand the roles and responsibilities of the local safety responsible person or the national QPPV and conduct day-to-day PV activities.