Introduction to pharmacovigilance (eLearning)

Pharmacovigilance (PV) is governed by strict regulatory and legislative standards and guidelines, and subject to regular audit and inspection. Consequences of non-compliance would include, but are not limited to, financial penalties, imposed limitations on/withdrawal of marketing authorisations, and most importantly a potential risk to public health.

This eLearning course provides a comprehensive overview of the principles of pharmacovigilance, a key function in all pharmaceutical companies to ensure continuous oversight of the benefits and risk of medicines and the early identification and management of safety concerns.

The course is suitable for anyone in the pharmaceutical industry that needs to gain knowledge of pharmacovigilance and drug safety. This could include those working in a pharmacovigilance and drug safety role that are new to pharmacovigilance or those in a junior role wishing to gain more knowledge and understanding.

Also relevant for Trainee QPs and to those working in Quality Assurance, Regulatory or Medical roles who need to understand the basic principles of pharmacovigilance and drug safety and start-up pharmaceutical companies with product/s currently at clinical trial stage with a need to understand pharmacovigilance/drug safety prior to gaining a MA license.

The course has 8 sections:

• What is pharmacovigilance?
• Pharmacovigilance Legislation, which is split into 5 sub-sections
• Systems
• Inspections and audits
• Risk management and adverse events
• Safety reports, studies and signal management
• Additional monitoring, safety communication and Risk Minimisation Measures
• Additional Guidance covering, Regulatory Guidance, Advisory Body Guidelines for UK and Ireland