About
Course Overview: This course is designed to provide a comprehensive understanding of signal detection and evaluation in pharmacovigilance. Participants will learn the fundamental principles, methodologies, and practical applications of signal detection to identify potential safety concerns associated with medicinal products. Target Audience: + Pharmacovigilance professionals + Medical safety officers + Data scientists + Clinical research associates + Regulatory affairs professionals Course Objectives: Upon completion of this course, participants will be able to: 1. Define signal detection and its importance in pharmacovigilance. 2. Understand the regulatory requirements for signal detection and reporting. 3. Identify and apply various signal detection methodologies, including data mining techniques and statistical methods. 4. Evaluate the strength of evidence for a potential safety signal. 5. Develop effective signal investigation strategies and risk management plans. 6. Communicate signal findings clearly and concisely to relevant stakeholders.
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