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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 3: Analytical Driven Trial Design

Session Chair(s)

Joanne  Malia, MS, MSc

Joanne Malia, MS, MSc

Director, Development Records Management

Regeneron Pharmaceuticals, United States

This session will discuss current automation and analytics to streamline and enhance quality of documentation for both pre-approval and post-approval activities. The first presentation will discuss how to better design clinical trial protocols and the second presentation will discuss the benefits of automation in Pharmacovigilance aggregate report writing.

Learning Objective :

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

  • Discuss how to use analytics to improve clinical trial design
  • Evaluate real-world time saving solutions to reduce your aggregate report writing by more than 50%
  • Identify strategies to reduce or manage risk in regulatory compliance by incorporating knowledge management


Robert  DiCicco, PharmD

Analytic Driven Trial Design: Are We There Yet?

Robert DiCicco, PharmD

TransCelerate Biopharma Inc., United States

Vice President, Portfolio Management

Kristen  Mandello, DVM

Automation, Efficiency, and Risk Mitigation in Regulatory Aggregate Report Writing

Kristen Mandello, DVM

Zoetis, United States

Global PV, Signal Detection Manager

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