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Tuesday, June 26 • 4:15pm - 5:15pm
#288: Is It Time to Change the Content and Format of Labeling?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-616-L04-P; CME 1.00; IACET 1.00; RN 1.00

How do you make labeling useful to patients and healthcare providers (HCPs) using the latest technology? This interactive panel session will include an FDA speaker, a patient representative, and an industry speaker, who will each provide insights into ensuring product labeling is useful and informative.

Learning Objectives

Identify new requirements for labeling content and format; Discuss opportunities for future enhancements to labeling to improve utility for patients and healthcare providers.

Chair

Ingrid Stahl Bryzinski

Speaker

Updating Prescription Drug and Biological Product Labeling
Eric Brodsky, MD

Industry Perspective
Kathy A. Clark, BSN, RN

Patient Perspective
Jeff Allen, PhD


Speakers
avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research
Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. A thought leader on many issues related to FDA, regulatory strategy and healthcare policy, he is regularly published in... Read More →
avatar for Eric Brodsky

Eric Brodsky

Associate Director, Labeling Development Team, Office of New Drugs, CDER, FDA
Dr. Brodsky [as the Associate Director of the Labeling Development Team in the Office of New Drugs at the Center for Drug Evaluation and Research at the FDA] oversees OND’s implementation of Prescribing Information (PI) regulations, guidances, and policies to help promote consistency... Read More →
avatar for Ingrid Bryzinski

Ingrid Bryzinski

Senior Director, Global Labeling, AbbVie
Ingrid has been involved in labeling since joining Abbott Laboratories in March 1997. Her group is responsible for creating the content of Company Core Data Sheets, the management of US Package Inserts and initial SmPCs for Europe as well as creating draft labeling for early phase... Read More →
avatar for Kathy Clark

Kathy Clark

Director, Global Regulatory Affairs, US Advertising and Promotion, Eli Lilly and Company
Kathy joined Eli Lilly and Company in 2000 & has held multiple positions within the Lilly Research division. Kathy assumed her current role as Director, Global Regulatory Affairs US Advertising & Promotion in 2013. Her current focus is the Diabetes portfolio of products and devices... Read More →

Tuesday June 26, 2018 4:15pm - 5:15pm
Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum