Global Labeling Conference

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Overview

As a direct and sole result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA has decided to change the format of the upcoming Global Labeling Conference from "face-to-face" (in-person) to entirely virtual.

For more information, please review the list of Frequently Asked Questions

April 20-21: Conference

DIA’s Global Labeling Conference is designed for professionals in medical product labeling and related disciplines as they work to develop and manage clear and accurate labeling information for the safe and effective use of prescription drugs, biologics, and medical devices. The efforts of these professionals are key to providing essential information needed by providers, patients, and payers to make decisions about product access, prescription, and use. Influences such as digital technology, patient centricity, evolving product classes, and changing regulations require the use of informed, systematic approaches throughout the labeling cycle to ensure the development and availability of current, compliant information in all regions where products are marketed.

This conference provides a forum for exchange among regulators and industry peers to update their knowledge of key local and global labeling policies and to examine the impact of changes on regulatory compliance. Most importantly, through interactive discussions with expert panels and peer-to-peer exchange, participants will share approaches, processes, and tools to ensure the availability of effective labeling content meeting the needs of patients, consumers, and prescribers.

Who should attend?

Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in:

Labeling
Regulatory Affairs/Drug Review and Approval Process
Clinical Safety/Pharmacovigilance
Pharmacoepidemiology
Medical Affairs and Communications
Medical Writing
Clinical Research and Development
Product Research and Development Alliances
Quality Control/Quality Assurance
Marketing/Advertising/Promotion

Learning objectives

At the conclusion of this conference, participants should be able to:

Discuss regional and global developments of labeling regulations/guidances, including digital, drug-device combination, and advanced therapy products, and their impact on company processes
Describe early labeling strategies and their role in product differentiation/marketing plans
Identify approaches for including patient perspectives and RWD in the creation of labeling content for regulatory approval and patient communication
Describe use of end-to-end tracking and compliance metrics to improve labeling processes and communications
Discuss management of reference label, patient labeling, and “beyond the label” information across global regions, including growth markets
Summarize recent audit trends and how peers monitor labeling implementation and address challenges

Program Committee

Paula Hudson, RPh, RAC • Advisor, Global Regulatory Affairs
Eli Lilly and Company, United States
Su-Yueh Lin, MS, RPh • Executive Director, Regulatory Labeling and Promotion
Intercept Pharmaceuticals, Inc., United States
Deborah Bebbington • Vice President, Head Labeling
Bayer Plc, United Kingdom
Theresa Brunone, MA, MS • Compliance Director, Global Labeling
GlaxoSmithKline, United States
Barbara Lachmann, MD • Sole Proprietor
Barbara Lachmann Labeling Consulting, Germany
Megann Looker • Senior Director, Head of Global Labeling, Global Regulatory Affairs
Jazz Pharmaceuticals, United Kingdom
Rie Matsui, RPh • Senior Director, Regional Labeling Head for APAC
Pfizer R&D, Japan
Gerrit Nijveldt, MSc •
EASi, United States
Hayley Parker, PhD, MSc • Head of Global Labeling, Global Regulatory Affairs
Vertex Pharmaceuticals, United States
Steven W. Bass, PhD • President
Bass Biopharm Consulting Group LLC, United States
A. Leander Fontaine, MD • President
Pharmiceutics, LLC., United States