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Sheraton Pentagon City Hotel

2024 年 03 月 14 日 7:30 上午 - 2024 年 03 月 15 日 4:15 下午

900 South Orme Street, Arlington, VA 22204, USA

Global Labeling Conference

Join speakers from around the world sharing their labeling – Germany, Japan, Belgium, UK, Canada and more!

概览

Conference: March 14-15, 2024

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.

Participant Testimonials

A fantastic opportunity to hear from the experts on the latest developments and best practices in the labelling area. – Suzanna Leacy, Director, Global Labeling Development, GSK

An excellent labeling conference. The speakers were excellent and knowledgeable. The sessions were the correct amount of time. I will definitely attend next year. – Carolyn McKelvie, Engagement Director, Luto Research

Featured

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Continuing Education

Highlights & Features

Welcome Video!

谁应该参加?

  • Meeting Designed For

    • 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

学习目标

  • At the completion of this conference, the participant should be able to:

    • Gain insights from global regulatory health authorities
    • Discuss best practices and learnings when implementing a broader target product labeling (TPL) process
    • Recognize global adoption trends of e-labeling initiatives and describe the best practices and challenges for implementation
    • Identify themes and trends in the labeling organizations of small and large companies
    • Apply recent patient centric labeling initiatives
    • Recognize regional requirements for compliant management of iterative product information
    • Discuss regulator interactions, early-stage developments, and global adoption patterns for e-labeling
    • Explain the use of AI and ML to support the work of labeling professionals

项目委员会

  • Kathleen  Salazar, MA, MBA
    Kathleen Salazar, MA, MBA Head, Global Labeling Implementation
    Johnson & Johnson Innovative Medicine, United States
  • Rie  Matsui, RPh
    Rie Matsui, RPh Senior Director, Regional Labeling Head for APAC, International Labeling
    Pfizer R&D Japan G.K., Japan
  • Deborah  Bebbington
    Deborah Bebbington Head Global Labeling
    Bayer Plc, United Kingdom
  • Lauren  Brunke, PharmD, RPh
    Lauren Brunke, PharmD, RPh Senior Director, Global Regulatory Affairs, Global Labeling
    Eli Lilly and Company, United States
  • Theresa  Brunone, MLS, MS
    Theresa Brunone, MLS, MS Head-Labelling Compliance and Implementation, Global Labeling
    GlaxoSmithKline, United States
  • Megann  Looker
    Megann Looker Executive Director, Head of Global Labeling
    Jazz Pharmaceuticals, United Kingdom
  • Gerrit  Nijveldt, MS, MSc
    Gerrit Nijveldt, MS, MSc Global Labeling Consultant
    Opus Regulatory Inc., United States
  • Hayley  Parker, PhD, MSc
    Hayley Parker, PhD, MSc Senior Vice President
    Pepgen Inc., United States
  • Mary Beth  Wilusz
    Mary Beth Wilusz Head, Regulatory Labeling Operations and Compliance
    Daiichi Sankyo, Inc., United States
  • Representative Invited
    Representative Invited DIA, United States
  • Steven  Bass, PhD
    Steven Bass, PhD President
    United States
  • Su-Yueh  Lin
    Su-Yueh Lin Sr. Labeling Consultant, Regulatory Affairs
    SYL Regulatory Consulting, Taiwan

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