About
Course Overview: This course is designed to provide comprehensive training in the principles and practices of pharmacovigilance and drug safety. Participants will gain a deep understanding of regulatory requirements, risk management, adverse event reporting, signal detection, and other critical aspects of drug safety. Course Objectives: Upon completion of this course, participants will be able to: + Understand the fundamental principles of pharmacovigilance and drug safety + Apply regulatory requirements (e.g., ICH GCP, ICH E2A, ICH E2B) to pharmacovigilance activities + Identify, assess, and manage safety risks associated with drug products + Efficiently report adverse events and other safety information + Conduct signal detection and risk minimization activities + Develop and implement pharmacovigilance systems and processes + Collaborate effectively with healthcare professionals, regulatory authorities, and other stakeholders Assessment: + Written Examinations: Multiple-choice and short-answer questions to assess knowledge and understanding + Practical Assignments: Completion of real-world tasks to demonstrate practical skills + Case Study Analysis: Evaluation of case studies to assess critical thinking and problem-solving abilities Certification: Upon successful completion of the course, participants will receive a certificate of completion.
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Overview
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Group Discussion
This program is connected to a group. You’ll be added once you join the program.