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Wednesday, June 29 • 4:00pm - 5:15pm
#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?

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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.

Chair

Heidi F. Gertner

Speaker

Panelist
Lene Garde Sommer

Panelist
Diane Macculloch Johnson, MS

Panelist
John Barlow Weiner, JD


Chair
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 →

Speakers
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 ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Forum