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概览

April 23: Short Courses
April 24-25: Conference


Labeling is a critical tool for the safe and effective use of prescription drugs, biologics, and medical devices. Its purpose is to convey the essential information needed by providers, patients, and payers to make decisions about product access, prescription, and use. Today’s environment of increasingly complex labeling regulations and guidances is especially challenging for products marketed in multiple regions, which demand worldwide consistency of prescribing and patient information. This Conference provides a forum for regulators and industry to update their knowledge of local and global labeling-related policies and to examine the impact of changes on regulatory compliance. Through expert panels and interactive discussions, participants will share approaches, processes, and tools to ensure effective labeling that meets regulatory expectations.

On-Demand Complimentary Webinar

What is Hot in Global Labeling?
This webinar will provide highlights of draft and recently approved regulations for awareness of potential impact to your global operations. This includes the revisions to the EU GVP Module IX guideline, SPL in Canada, updating of labeling in Japan and device regulations in the EU.
Register today!


Featured Topics

  • Global Labeling Issues and Updates
  • Labeling Role
  • Pharmacovigilance Risk Assessment
  • Packaging Issues
  • Combination Products
  • Biosimilars
  • Patient Leaflet
  • Plain Language Labeling
  • Patient Medication Information (PMI)
  • International Strategic Plan

谁应该参加?

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

  • Labeling
  • Clinical Safety/pharmacovigilance
  • Pharmacoepidemiology
  • Regulatory affairs/drug review and approval process
  • Medical affairs and communications
  • Medical writing
  • Clinical research and development
  • Product research and development alliances
  • Quality control/quality assurance

学习目标

At the conclusion of this activity, participants should be able to:

  • Discuss new labeling-related developments and regulations (e.g., Canada, EU, Japan, Asia, Latin America, Middle East, Africa, and US)
  • Describe the impact of proposed changes to regional and global labeling requirements and implications for labeling practice and processes
  • Analyze the impact of current and proposed global and region-specific labeling policies for combination products, biosimilars, and generic drugs on labeling development and product lifecycle practices
  • Assess the advantages and limitations of various labeling processes and document management systems commonly used in companies
  • Describe global labeling compliance expectations and best practices

项目委员会

  • Steven W. Bass, PhD
    Steven W. Bass, PhD President
    Bass Biopharm Consulting Group LLC, United States
  • Su-Yueh  Lin, MS, RPh
    Su-Yueh Lin, MS, RPh Regulatory Labeling Consultant
    Independent Consultant, United States
  • Mark A. Collins, PhD, MBA
    Mark A. Collins, PhD, MBA Global Labeling Lead
    CSL Behring, United States
  • Barbara J. Fanelli, MSc
    Barbara J. Fanelli, MSc Associate Adjunct Professor
    Temple University School of Pharmacy, United States
  • A. Leander  Fontaine, MD
    A. Leander Fontaine, MD President
    Pharmiceutics, LLC., United States
  • Paula  Hudson, RPh, RAC
    Paula Hudson, RPh, RAC Director, Global Labeling
    Eli Lilly and Company, United States
  • Barbara  Lachmann, MD
    Barbara Lachmann, MD Consultant
    Barbara Lachmann Labeling Consulting, Germany
  • Megann  Looker
    Megann Looker Director, EU/RoW Labelling and Advertising/Promotion
    United Kingdom
  • Rie  Matsui, RPh
    Rie Matsui, RPh Director, Regional Labeling Head for Asia, International Labeling Group
    Pfizer Japan Inc., Japan
  • Gerrit  Nijveldt, MSc
    Gerrit Nijveldt, MSc Senior Director of Labeling
    Sanofi US, United States
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