Pharmacovigilance: Signalling and Risk Assessment (English)

Our Good Pharmacovigilance Practice (GVP) online training platform allows you to access our courses from wherever you are. Get trained and certified at your convenience. If you are involved in any aspect of pharmacovigilance (GVP), our four-course modules will help you comply with European and US laws. The modules are ideal for professionals involved in drug safety, pharmacovigilance, regulatory affairs, and quality compliance. The Pharmacovigilance Signalling and Risk Assessment course is recommended for those involved in drug safety, clinical trials, pharmacoepidemiology, and risk management. The Pharmacovigilance Signalling and Risk Assessment course covers key components of signal detection, including definitions, objectives, examples, FDA risk management components, EU signalling requirements, and data-mining principles. Each of these factors is crucial for a company to ensure compliance with legislation. One of the primary objectives of signalling and risk management is to understand and manage the risk profiles of drugs to help avoid extremely expensive and damaging drug withdrawals. Pharmacovigilance Signalling and Risk Assessment is a valuable addition to your pharmacovigilance knowledge when combined with the Pharmacovigilance Audit course. The course includes interactive mini-exams at the end of each chapter to help reinforce learning.

This course comprehensively explains signalling and risk assessment in pharmacovigilance, including an overview of data mining, signal detection, and regulatory requirements across European and American markets. Keeping products on the market without interruption has become more essential due to the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance is key to product longevity, consumer confidence, and regulatory compliance. This module provides a strong foundation of knowledge in pharmacovigilance and drug safety.