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Overview

Short Course : April 1
Short Course : April 1

Conference: April 4-5

DIA is offering a virtual conference for the Global Labeling Conference that allows you to view all the session recordings from the comfort of your own home/office. Can't make all the sessions live? You will receive access to the On Demand library with your registration for 2 months post-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 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

Learning objectives

At the conclusion of this activity, participants should be able to:
  • Identify the key labeling requirements in major markets
  • Discuss the concept of digital labeling and forms it may take in making product information available to patients and prescribers
  • Examine the regulations supporting drug prescribing information in Latin America and the Caribbean and identify the changes in
  • UK MHRA regulations as a result of Brexit – both those that are new and still in transition
  • Explain how labeling operations governance groups can be used to monitor submission and implementation metrics and oversee and influence labeling compliance
  • Explain the value of labeling during drug development from a global and local perspective
  • Describe the opportunities and challenges of patient-centric drug labeling for all stakeholders
  • Describe the different types of non-traditional data and the possibility and pros/cons for inclusion in labeling or promotional materials
  • Describe the latest information regarding the current regulations and guidance for combination product and medical device labeling in the US and EU

Program Committee

  • Su-Yueh  Lin
    Su-Yueh Lin VP of Operation
    BRIM Biotechnology, Inc., Taiwan
  • 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 Head, RA Labeling
    Bayer Plc, United Kingdom
  • Theresa  Brunone, MA, MS
    Theresa Brunone, MA, MS Head-Labelling Compliance and Implementation, Global Labeling
    GlaxoSmithKline, United States
  • Lauren  Brunke, PharmD, RPh
    Lauren Brunke, PharmD, RPh Senior Director – GRA-NA Global Labeling Department (GoLD)
    Eli Lilly and Co, United States
  • 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
    Japan
  • Gerrit  Nijveldt, MSc
    Gerrit Nijveldt, MSc Global Consultant Labeling
    Opus Regulatory, United States
  • Hayley  Parker, PhD, MSc
    Hayley Parker, PhD, MSc VP Regulatory Affairs
    Scholar Rock, United States
  • Steven  Bass, PhD
    Steven 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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