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Safety Reporting: What Writers Need to Know

Track:
Medical Writing Regulatory Topics

Day & Time:
March 12, 10:00AM - 11:30AM

Room Number:
Ballroom Salon H

Type:
Session

Title:
Safety Reporting: What Writers Need to Know

Chair(s):
Eileen Girten
Senior Medical Writer
inVentiv Health Clinical, United States

Description:
Harmonization efforts have led to standard safety reporting formats, such as the Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), and the recent Periodic Benefit-Risk Evaluation Report (PBRER). This session will summarize the evolution of the PSUR to the PBRER, compare and contrast the PBRER/PSUR to the DSUR, and provide practical approaches to preparing DSURs/PSURs/PBRERs.

Learning Objective(s):
At the conclusion of this session, participants should be able to:
Identify the challenges to preparing DSURs/PSURs/PBRERs
Identify best practices for preparing safety documents

Presentation(s) & Speaker(s):
Development Safety Update Reports
Angela Thompson
Principal Medical Writer
inVentiv Health Clinical, United States

The Pains, Benefits, and Realities in Evolving Your Reports
Valerie Perentesis, PharmD
Sr. Dir., Aggregate Reports & Product Safety Eval, Group Lead Global Med Safety
Janssen Research & Development, LLC, United States

© 2014 DIA