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Enhancing Benefit-Risk Management through the Product Life Cycle

Track:
What is the Future of Pharmacovigilance?

Day & Time:
April 18, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:
S0501

Room Number:
Sydney

Level:
Intermediate

Type:
Session

Title:
Enhancing Benefit-Risk Management through the Product Life Cycle

Chair(s):
Steve Mayall, PhD
Principal Consultant
Pope Woodhead & Associates Ltd, United Kingdom

Description:
The importance of pharmacovigilance continues to increase along with complexities in data collection, scientific methodology, technology advances and resource constraints. This session will take a look at innovative approaches to benefit/risk management, risk communication and measuring the impact of pharmacovigilance activities and discuss the experience with recently implemented elements of the Pharmacovigilance legislation.

Learning Objective(s):
1. To perform structured benefit-risk assessment effectively consistent with regulatory guidance; 2. To produce high quality, impactful benefit-risk information; 3. To identify and overcome the key challenges of implementing benefit-risk assessment within an organisation.

Presentation(s) & Speaker(s):
Regulator Perspectives
Jordi Llinares Garcia, MS
Head of Scientific and Regulatory Management
European Medicines Agency (EMA), United Kingdom

Digital Risk Management: Opportunities and Challenges
Helen Kathryn Edelberg, MD, MPH, FACP
Head, Medical Safety Assessment, Innovative Medical and Global Safety Risk Mgt
Bristol-Myers Squibb, United States

The benefits and risks of performing structured benefit-risk assessments
Steve Mayall, PhD
Principal Consultant
Pope Woodhead & Associates Ltd, United Kingdom