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Tuesday, June 28 • 4:00pm - 5:15pm
#273: Improving Adverse Drug Reaction Information in Product Labels

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Adverse drug reactions (ADRs) are an important part of a product label. In this session, we will recommend ways to make ADR information in product labels more understandable and better reflective of the risk of a drug relative to a comparator. We will also discuss the importance of end-to-end labeling and tracking to ensure pharmacovigilance compliance.

Learning Objectives

Discuss how adverse drug reactions (ADRs) are presented in EU and US drug labels; Explain why the qualitative categories of ADR in an EU label and the pooling strategy to obtain ADR frequencies in a US label are inadequate; Describe improved approaches to summarize and present different types of adverse events; Describe key building blocks for a compliant end-to-end labeling system.

Chair

Brenda Crowe, PhD

Speaker

Rational Presentation of Adverse Reactions in Drug Labeling
Ellis Unger, MD

A New Paradigm in Patient Safety: The Importance of End-to-End Labeling and Tracking in Ensuring Pharmacovigilance Compliance
Oliver Steck, MBA

Augmenting Product Labels with Real-World Evidence: Lessons from OHDSI
Patrick Ryan



Chair
avatar for Brenda Crowe

Brenda Crowe

Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 18 years of pharmaceutical industry experience.

Speakers
PR

Patrick Ryan

Head, Epidemiology Analytics, Janssen Pharmaceuticals, Inc.
Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development. He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI, htttp://ohdsi.org). He served as a principal investigator of the Observational Medical Outcomes Partnership (OMOP), a public-private partnership chaired by the FDA. Patrick received his PhD in Pharmaceutical Outcomes and... Read More →
avatar for Oliver Steck

Oliver Steck

Principal, Navitas Inc.
He has been a business consultant for more than 14 years. Since joining WCI, he has helped global pharmaceutical clients to optimize their processes in regards of content management, different compliance related issues, risk management and Pharmacovigilance.
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist and cardiologist. Prior to coming to CDER in 2003, previous positions included director of a translational angiogenesis program at NHLBI, NIH; and Medical Officer... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA