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Bethesda North Marriott Hotel and Conference Center

Apr 24, 2018 7:00 AM - Apr 25, 2018 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling Conference


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


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Who should attend?

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

Learning objectives

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

Short Course or Primer

To keep you at the forefront.

Apr 23, 2018

Course 1:

EU Inspections and Audit Readiness Plans

Apr 23, 2018

Course 2:

Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management

Program Committee

  • Steven  Bass, PhD
    Steven Bass, PhD President
    Bass Biopharm Consulting Group LLC, United States
  • Su-Yueh  Lin
    Su-Yueh Lin Sr. Labeling Consultant, Regulatory Affairs
    SYL Regulatory Consulting, Taiwan
  • Mark  Collins, PhD, MBA
    Mark Collins, PhD, MBA Principal Consultant
    Opus Regulatory, 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 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

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