Overview:

This expert-level course focuses on the critical role of literature monitoring in Pharmacovigilance, highlighting its importance in identifying adverse events and ensuring compliance with global safety reporting regulations. It covers advanced techniques for literature search, screening, and tracking ICSRs, with hands-on exercises to build proficiency in handling real-world challenges. Additionally, the course delves into regulatory requirements, compliance tracking, and strategies to ensure the completeness and accuracy of data derived from scientific publications.

Objectives:

1. To provide a detailed understanding of the literature monitoring process and its regulatory significance.
2. To master advanced search strategies using specialized databases and keywords.
3. To develop expertise in screening and extracting ICSRs from scientific articles.
4. To create and maintain effective trackers for literature monitoring activities.
5. To handle compliance checks and audits related to literature monitoring.

Outcomes:

By the end of this course, learners will:

• Demonstrate proficiency in conducting literature searches and identifying ICSRs.
• Develop and implement effective tracking systems for monitoring activities.
• Ensure compliance with regulatory requirements for literature monitoring and reporting.
• Gain confidence in handling real-world scenarios, including ambiguous or incomplete data in literature sources.

Hands-On Training Components:

1. Database Searches:
• Perform searches using PubMed and Embase to identify articles containing ICSRs.
• Practice using Boolean operators, filters, and database-specific tools.
2. Screening Workshops:
• Screen provided articles for relevant ICSRs, extracting key information for case processing.
3. Tracker Design:
• Create and maintain trackers to log search strategies, article screening, and extracted cases.
4. Compliance Exercises:
• Simulate a compliance check for a literature monitoring activity, identifying gaps and resolving issues.

Assessment Criteria:

• Knowledge Evaluation:
• Quizzes and scenario-based questions on search strategies, regulatory requirements, and compliance.
• Practical Application:
• Evaluation of hands-on exercises, including article screening, case extraction, and tracker creation.
• Submission of a completed literature monitoring tracker with annotated cases for review.