Dive into the realm of pharmacovigilance with our course “Entering data into the Pharmacovigilance database system”. This tailored course is structured to impart a deep understanding of pharmacovigilance database requirements and the intricacies of handling Individual Case Safety Reports (ICSRs) using the PV database. Ideal for beginners aiming to enter or professionals seeking to deepen their expertise in pharmacovigilance, this course equips participants with essential skills for effective safety data management and regulatory compliance.
What will you learn?
- Understand Pharmacovigilance Database Requirements: Grasp the essentials of ICSR submissions to the Eudravigilance database.
- Navigate ICSR Forms: Learn the differences between the E2B R2 and the new E2B R3 forms, including detailed guidance on filling out and interpreting various data elements.
- Manage Special Case Scenarios: Acquire techniques for managing reports of exposure during pregnancy and other specific case scenarios within the pharmacovigilance framework.
- Develop Follow-up Skills: Understand the requirements and methods for conducting thorough follow-up activities with reporters to ensure comprehensive case documentation.
- Master Reporting Dynamics: Get familiar with the dynamics of ICSR forms, including coding management, handling amendments and follow-up management.
Course Highlights:
- Expert-Led Presentations: Learn from presentations crafted by top subject matter expert, which include the latest updates and practices in pharmacovigilance.
- Hands-On Practice Activities: Engage in practical activities and assessments designed to simulate real-world pharmacovigilance tasks, enhancing your operational proficiency.
- Certification of Competence: Successfully pass the course test to receive a certificate that validates your newly acquired pharmacovigilance skills.
- Interactive Learning Platform: Participate in an interactive online environment that encourages dialogue and collaboration among fellow learners, fostering a rich learning experience.
Embark on your journey to mastering pharmacovigilance practices with our “Entering data into the Pharmacovigilance database system” course. Whether starting a new career or advancing in the field, this course provides a solid foundation in pharmacovigilance principles combined with practical skills for immediate application. Join us for a transformative educational experience that bridges theoretical knowledge with real-world applications.
