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Labeling [clear filter]
Tuesday, June 28

4:00pm EDT

#273: Improving Adverse Drug Reaction Information in Product Labels
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.


Brenda Crowe, PhD


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

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 20 years of pharmaceutical industry experience.


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... 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... Read More →

Tuesday June 28, 2016 4:00pm - 5:15pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Session
Wednesday, June 29

4:00pm EDT

#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

Cross-labeling poses regulatory challenges. Device and drug labeling may mention another product, but the reference is not mirrored. This session will present the challenges faced by both FDA and regulated industry to properly align labels of drugs and devices intended to be used together.

Learning Objectives

Discuss the regulatory challenges of aligning the labels of drugs and devices approved for combined use under separate applications; Explore the possible regulatory solutions to better aligning labels for drugs and devices intended to be used together; Identify the challenges misaligned labeling presents for industry, patients, health care practitioners, and regulators.


Heidi F. Gertner


Lene Garde Sommer

Diane Macculloch Johnson, MS

John Barlow Weiner, JD

avatar for Heidi Gertner

Heidi Gertner

Partner, Hogan Lovells US LLP
Heidi Gertner is a partner at Hogan Lovells in their drug regulatory group. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at NIH. Heidi then worked at the FDA's Office of Chief... Read More →

avatar for Diane Johnson

Diane Johnson

Senior Director, North American Regulatory Affairs Policy and Intelligence, Johnson & Johnson
Diane is responsible for providing key strategic direction and regulatory intelligence across the North America device sector. Supports shaping of growth plans by translating the impact of regulatory environmental changes/trends on Strategic Business Plans. 20yrs of experience in... Read More →
avatar for Lene Sommer

Lene Sommer

Vice President, RA Devices, Novo Nordisk A/S
VP of Regulatory Affairs Devices at Novo Nordisk A/S. Responsible for regulatory strategies for development of devices as well as maintenance of devices on the market. She has more than 18 years of experience in the world of pharmaceuticals (medical devices). She has wide experience... Read More →
avatar for John Weiner

John Weiner

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA