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Nov 10, 2015 11:00 AM - Nov 10, 2015 12:30 PM

(Eastern Standard Time)

Online

Part 3: Assessing the Safety of Medications and Vaccines in Pregnancy: The Vaccines and Medications in Pregnancy Surveillance System

Overview

Series Overview: This 4-part webinar series is designed to introduce the recent revisions to the Pregnancy and Lactation Labeling Rule, discuss resulting policy decisions, and describe different approaches for proactively gathering relevant data. This series will follow the 2015 DIA Annual Meeting, and content will continue discussion of ideas generated at the 2015 Annual Meeting forum on methodologies to increase availability and understanding of the safety information for products used by pregnant and lactating women. The series will culminate in a workshop/forum at the DIA 2016 Annual Meeting on multiple and complementary approaches for collecting and sharing safety data on medications used by pregnant and lactating women.

The format for this webinar series is a panel discussion including industry and academic experts, government and regulatory authorities and other stakeholders, promoting a lively discussion and exchange of ideas.  A question-and-answer session will be offered for the live webinar audience. 


In Part 3, we will describe the structure and function of VAMPSS and present the differences between VAMPSS and other approaches in providing valid gestational safety information that can be included in the new pregnancy label.


Links to Remaining Series Parts

Series Part 1

Series Part 2

Series Part 4

Who should attend?

Individuals involved in:

  • Pharmacology/Toxicology
  • Clinical Pharmacology
  • Risk Communication
  • Risk Management
  • Clinical Research and Development
  • Labeling
  • Regulatory Affairs
  • Clinical Safety and Pharmacovigilance
  • Post Market Studies
  • Health Economics and Outcomes Research
  • Medical Information and Affairs
  • Medical Writing
  • Patient Engagement
  • Statistics
  • Legal Affairs
  • Strategic Planning/Research and Development

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Describe the structure and function of the VAMPSS system
  • Recognize the differences between VAMPSS and traditional pharmaceutical company registries
  • Examine the differences and advantages by comparing multiple database approaches in retrieving data
  • Discussd how VAMPSS can provide valid gestational safety information that can be included in the new pregnancy label

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