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

Registration Questions?

Send Email
1.888.257.6457


Additional Information

Global Labeling Resource Kit


On Demand Content Preview Webinar

Audit Trends in Labeling
VIEW NOW

Still not convinced?

Check out our "medicine cabinet" infographic for hot topics on tap and featured sessions at the conference.
View Infographic

Digital Learning Catalog

DIA Learning: eLearning Soultions
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