Course description
This comprehensive training course equips professionals with essential knowledge and skills in pharmacovigilance, focusing on drug safety monitoring. The curriculum delves into principles, methods, and regulations, covering adverse event reporting, signal detection, and risk management. Key topics include Good Pharmacovigilance Practices (GVP) and international guidelines, supplemented by practical case studies. This course is ideal for individuals in pharmaceutical companies, regulatory agencies, and clinical research organizations responsible for ensuring the safety and efficacy of medicinal products throughout their lifecycle. Upon completion, participants will be well-prepared to contribute to a robust drug safety system.
What will i learn?
Requirements
Frequently asked question
This pharmacovigilance course is intended for a diverse group of professionals, such as doctors, pharmacists, and life science graduates, as well as anyone pursuing a career in drug safety and pharmacovigilance.
A background in life sciences, such as a degree in pharmacy, medicine, dentistry, or a related field, is recommended. However, individuals with a keen interest in the subject may also enroll.
This course encompasses fundamental principles of pharmacovigilance, adverse event reporting, causality assessment, risk management, adherence to regulatory guidelines (such as ICH-GCP), and the utilization of safety databases.
The course commences with foundational pharmacovigilance concepts and progressively delves into more intricate subjects, rendering it appropriate for both novices and individuals with prior experience.
Upon successful completion of the course and associated assessments, a certificate of completion will be issued.
Indeed, the curriculum incorporates practical exercises, case studies, and interactive discussions, facilitating the application of theoretical knowledge to authentic, real-world situations.
The duration of the course may vary based on its format (e.g., self-paced, instructor-led). Kindly refer to the specific course details for precise information regarding its length.
A certification in pharmacovigilance can facilitate access to diverse professional opportunities, including roles such as Drug Safety Associate, Pharmacovigilance Scientist, Medical Coder, and positions within regulatory affairs and clinical research.
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Lectures
8
Skill level
Beginner
