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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

DIA EUROPE 2018

Enhancing Benefit-Risk Management through the Product Life Cycle

Session Chair(s)

Steve  Mayall, PhD

Steve Mayall, PhD

Director

Huron Consulting Group, United Kingdom

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 : 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.

Speaker(s)

Jordi  Llinares Garcia, MS

Regulator Perspectives

Jordi Llinares Garcia, MS

European Medicines Agency, Netherlands

Head of Research and Innovation

Helen  Edelberg, MD, MPH, FACP

Digital Risk Management: Opportunities and Challenges

Helen Edelberg, MD, MPH, FACP

FDA, United States

Deputy Office Director for Safety, Office of New Drugs

Steve  Mayall, PhD

The benefits and risks of performing structured benefit-risk assessments

Steve Mayall, PhD

Huron Consulting Group, United Kingdom

Director

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