Pharmacovigilance: Signalling and-risk-assessment (English)

Our Good Pharmacovigilance Practice (GPV) 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 (GPV), our four-course modules will help you comply with European & US law. The modules are perfect for you if you are involved in drug safety, pharmacovigilance, regulatory and quality compliance. The Pharmacovigilance Signalling & Risk Assessment course is recommended if you are involved in drug safety, clinical trials, pharmacoepidemiology and risk management. The Pharmacovigilance Signalling & Risk Assessment course covers key components of signal detection, including; definitions, objectives, examples, FDA risk management constituents, EU Signalling requirements and data mining principles. Each of these factors is crucial for a company to ensure that they match legislation – one of signalling and risk management’s primary objectives is to understand and manage the risk profiles of drugs to help avoid hugely expensive and damaging drug withdrawals. Pharmacovigilance Signalling & Risk Assessment is a great addition to your knowledge in pharmacovigilance when combined with The Pharmacovigilance Audit course. The course contains 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 its requirements across European and American markets. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.