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Omni Shoreham Hotel

22 ene 2018 7:00 a.m. - 24 ene 2018 5:00 p.m.

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

Session 11: Hot Topics

Session Chair(s)

Michael  Richardson, MD, FFPM, FRCP

Michael Richardson, MD, FFPM, FRCP

Senior Vice President, WorldWide Patient Safety

Bristol-Myers Squibb, United Kingdom

This session will cover areas of drug safety which are problematic and require industry and regulators to work together in managing data in the post-approval space, in particular from multiple sources, both structured and unstructured data collection activities. Speakers will present on projects looking at what data can be of value to identifying signals and safety evaluation, how to manage real-world data such as the sentinel programs, and how best to utilize the specific risk management effectiveness evaluations through moving to a digital platform. Speakers will present on their topics then a joint panel for a Q&A will take place.

Speaker(s)

Mark  Perrott, PhD

Digital Approach to Risk Minimization

Mark Perrott, PhD

Axian Consulting Ltd., United Kingdom

Managing Partner

Jeremy  Jokinen, PhD, MS

Value of Safety Information Data Sources

Jeremy Jokinen, PhD, MS

Bristol-Myers Squibb Company, United States

Vice President and Head, Safety Evidence and Sciences

Peter  Verdru, MD

Speaker

Peter Verdru, MD

UCB Biopharma S.P.R.L., Belgium

Vice President, Head of Patient Safety

Vicki  Edwards, RPh

Speaker

Vicki Edwards, RPh

Abbvie, United Kingdom

Vice President, Pharmacovigilance Excellence and International QPPV

D. Tyler  Coyle

Sentinel ARIA Process

D. Tyler Coyle

Food and Drug Administration, United States

Medical Officer

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