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Expanding the Scope: Empowering the Public in Pharmacovigilance

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
346

Room Number:
30AB

Level:
Intermediate

Type:
Symposium

Title:
Expanding the Scope: Empowering the Public in Pharmacovigilance

Chair(s):
Magnus Wallberg, MSc
Product Manager Technical Solutions
Uppsala Monitoring Centre, Sweden

Description:
This session will discuss various tools currently being used to track adverse events reporting and data. We will discuss the VigiBase data resource which is the largest and most comprehensive source of spontaneous reports and is updated with incoming ICSRs on a continuous basis and the FDA will discuss MedWatchLearn, a web-based learning tool designed to educate health professionals and consumers/patients about reporting in a way that provides the best information for FDA reviewers to further investigate medical product problems.

Learning Objective(s):
Identify at least two tools currently being used to track adverse events reporting.

Presentation(s) & Speaker(s):
Opening the WHO ICSR Database for Public Access
Magnus Wallberg, MSc
Product Manager Technical Solutions
Uppsala Monitoring Centre, Sweden

New FDA Tools for Adverse Event Reporting: MedWatchLearn, Mobile Technology, and Consumer/Patient MedWatch Form 3500B
Anna M Fine, PharmD, MS
Director, Health Professional Liaison Program, Office of the Commissioner
FDA, United States

EMA Perspective
Sabine Brosch, PharmD, PhD
Monitoring and Incident Management, Pharmacovigilance Department
European Medicines Agency, United Kingdom