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Virtual Event

2020年4月20日 (月) 午前 7:45 - 2020年4月21日 (火) 午後 2:45

(US Eastern Standard Time)

Horsham, PA 19044

Global Labeling Conference

This event is now offered in a new entirely virtual format.

概要

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.




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Continuing Education

Highlights & Features

参加対象

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

学習目的

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

プログラム委員会

  • Paula  Hudson, RPh, RAC
    Paula Hudson, RPh, RAC Director, Global Labeling
    Eli Lilly and Company, United States
  • Su-Yueh  Lin
    Su-Yueh Lin Sr. Labeling Consultant, Regulatory Affairs
    SYL Regulatory Consulting, Taiwan
  • Deborah  Bebbington
    Deborah Bebbington Head Global Labeling
    Bayer Plc, United Kingdom
  • Theresa  Brunone, MLS, MS
    Theresa Brunone, MLS, MS Head-Labelling Compliance and Implementation, Global Labeling
    GlaxoSmithKline, 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, International Labeling
    Pfizer R&D Japan G.K., Japan
  • Gerrit  Nijveldt, MSc
    Gerrit Nijveldt, MSc Global Labeling Consultant
    Opus Regulatory Inc., United States
  • Hayley  Parker, PhD, MSc
    Hayley Parker, PhD, MSc Vice President Regulatory Affairs
    PepGen, 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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