DIA
Drug Information Association Logo
« Back to Listing

Compliance, Potential Financial Implications, and Impact of New Safety Measures

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
395

Room Number:
8

Level:
Intermediate

Type:
Session

Title:
Compliance, Potential Financial Implications, and Impact of New Safety Measures

Chair(s):
John Whitebrook
Director
Deloitte Consulting LLP, United States

Description:
This session will discuss how industry has adapted and the real-world impacts of the legislation on pharmacovigilance organizations and processes. Adoption of new legislation, originating in all regulatory regions, requires significant investment from industry. However, the return on that investment is difficult to identify and/or quantify. The rising cost of drug safety is a concern to all stakeholders. Some new approaches, such as risk evaluation and mitigation strategies (REMS), are expected to show a return but also have limitations and are not always deemed to meet the needs of patients. This session will also consider how to address the inevitable increasing involvement of patients and mass media, without the costs of drug safety continuing to spiral.

Learning Objective(s):
Discuss how safety measures can increase productivity while containing costs; Identify how to involve, and collaborate with, external groups such as patients; Discuss the impacts of Good Pharmacovigilance Practices (GVP) on industry; Gain insights into pragmatic approaches to deal with GVP in the real world.

Presentation(s) & Speaker(s):
Good Pharmacovigilance Practices (GVP): The Real Impacts and Consequences
John Whitebrook
Director
Deloitte Consulting LLP, United States

Industry Perspective
Peter K. Honig, MD, MPH
Vice President and Head, Global Regulatory Affairs and Patient Safety
AstraZeneca, United States

Financial Implications of Drug Safety Measures and a Potential Remedy
Tatsuo Kurokawa, PhD
Professor, Div. of Drug Development and Regulatory Sciences, Faculty of Pharmacy
Keio University, Japan