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Jun 04, 2024 9:30 AM - Jun 04, 2024 12:30 PM

Signal Management in Pharmacovigilance

This is a virtual pre-meeting Short Course in conjunction with the DIA Global Annual Meeting.


Pre-registration required and is an additional fee.

*Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory.

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This Short Course will be offered virtually – Join from anywhere! This short course covers all aspects of the Signal Management process. The course is sub-divided into two modules:

  1. The first module discusses the Importance of robust and efficient Signal Management, and the Signal Detection step: we discuss definitions, applicable regulations, methodologies, quantitative v. qualitative techniques, and common datasets reviewed.
  2. The second module covers Signal Validation where the validation process, relevance, and possible conclusions shall be elaborated. Next, we discuss the Signal Assessment process in detail. We start with the various data-sources that can be evaluated and their relative importance, explain the formulation of the search strategy, and finally outline the key aspects of case assessment and literature summarization. We cover the basic structure of the Signal Assessment Report and discuss the importance of using multiple data sources for a comprehensive signal assessment. We end by touching upon various possible outcomes of the Signal Management process.

We do not aim to have an entirely theoretical discussion on this complex topic: illustrative examples will be described to illustrate how the principles discussed are put into practice. At the end of the course, participants can expect to have a good understanding of Signal management from a theoretical and practical standpoint.

Register for two or more Short Courses and receive $50 off each Short Course! Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

    Who should attend?

    Drug Safety and Clinical Trial professionals with at least a basic understanding of safety signals and who want to better understand the details of the various processes involved, as well as how signal management fits into the bigger picture of Patient Safety. This course would be helpful to individuals who have recently started, or are looking to start, in a Signal Management/Brand Safety role.

    Learning objectives

    At the conclusion of this short course, participants should be able to:
    • Evaluate the importance and relevance of Signal Management in the current Regulatory environment and Patient Centricity
    • Discuss the challenges associated with Management of Safety Signals and provide strategies to overcome these challenges
    • Identify recent advances with AI for Signal Management and future possibilities

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