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Virtual

May 09, 2024 11:00 AM - May 09, 2024 12:00 PM

(US Eastern Standard Time)

Signal Management: Pre-Marketing vs Post-Marketing

Overview

Whether you are working in safety or interested in learning more about signal management, this live-virtual webinar is for you!

Don’t miss the opportunity to hear from DIA's expert in this sector for clarification on the application of the EU Pharmacovigilance Module IX to safety signal management, and what resources DIA has curated to earn a certificate in Drug Safety and Pharmacovigilance.

Join us for a short presentation on the signal management process and how it applies to data sources.  You’ll have the advantage of learning from a key opinion leader as the following questions are addressed:

  • How does the signal management process differ between clinical development and post-marketing?
  • Why was the EU GVP Module IX guideline developed?
  • What are the steps in the signal management process as it applies to the data sources available?

Developing the Components for a Signal Management Program – The EU Good Vigilance Practice (GVP) Module IX is a comprehensive approach to the safety signal management steps in post-marketing surveillance, but can these same steps be applied to signal management in the clinical development period? Faculty will share their experience with the similarities and differences in the signal management process described in Module IX in the clinical development and post-marketing periods.

You will have the opportunity to ask the expert about signal management processes specifically in your work.

Registration is free! Don’t Wait, Register today!

Learning objectives

  • Describe how the signal management process differs between clinical development and post-marketing
  • Explain the context in which the EU GVP Module IX guideline was developed
  • Explain the steps in the signal management process as it applies to the data sources available
  • Discuss important additional steps in the signal management process that are not described in GVP Module IX

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