DIA 2018 Global Annual Meeting

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-676-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this provocative session, executives from various sponsor organizations will react to the 2017 industry report on risk in clinical trials. They will share its 2017 industry findings on the state of clinical outsourcing, risk assessment, and risk-based approaches to managing quality and oversight in the context of a changing regulatory landscape. With a near equal balance of respondents identifying as using primarily FSP or primarily Full-Service models, they will shed light on what the data says about the impact of sourcing model on quality, relationships, and risk-based approaches.Forward-thinking executive leaders from pharma and CRO respondents will respond to the findings with their own interpretations, describe strategies where threats and opportunities may be addressed, and promote their own unique view.

Learning Objectives

Assess the impact of clinical outsourcing model on quality, relationships, and risk-based approaches; Describe strategies addressing threats and opportunities in the changing regulatory landscape.

Chair

Mitchell A. Katz, PhD

Speaker

Panelist
David M. Johnston, PhD

Panelist
John Oidtman

Panelist
Jeremy G. Chadwick