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Overview

Short Course
Conference: April 4-5

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.

Social distancing measures may be in place at the time of the event. Therefore, we encourage you to register and make your housing arrangements early due to potential limited capacity. If the capacity limit is reached, we will only be able to offer the virtual option. Don’t miss out on your chance to meet live again with your friends and colleagues!

Who should attend?

Professionals from biopharmaceutical and device companies, regulatory authorities, CROs, and consulting agencies 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

Program Committee

  • Su-Yueh  Lin, MS, RPh
    Su-Yueh Lin, MS, RPh Executive Director, Regulatory Labeling and Promotion
    Intercept Pharmaceuticals, Inc., United States
  • Kathy  Salazar, MA, MBA
    Kathy Salazar, MA, MBA Head, Global Labeling Implementation, Global Labeling COE
    Janssen Research & Development/Johnson & Johnson, United States
  • Deborah  Bebbington
    Deborah Bebbington Vice President, Head of Global Labeling
    Bayer Plc, United Kingdom
  • Theresa  Brunone, MA, MS
    Theresa Brunone, MA, MS Compliance Director, Global Labeling
    GlaxoSmithKline, United States
  • Lauren  Brunke, PharmD, RPh
    Lauren Brunke, PharmD, RPh Director, Global Regulatory Affairs, Global Labeling Department
    Eli Lilly and Co, United States
  • Barbara  Lachmann, MD
    Barbara Lachmann, MD Sole Proprietor
    Barbara Lachmann Labeling Consulting, Germany
  • Megann  Looker
    Megann Looker Executive Director, Head of Global Labeling
    Jazz Pharmaceuticals, United Kingdom
  • Rie  Matsui, RPh
    Rie Matsui, RPh Senior Director, Regional Labeling Head for APAC
    Pfizer R&D Japan G.K., Japan
  • Gerrit  Nijveldt, MSc
    Gerrit Nijveldt, MSc Global Consultant Labeling
    Opus Regulatory, 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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