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Overview

Global Labeling 2016: Essential Updates on Worldwide Regulations and Guidelines


Short Courses*: September 11
Conference: September 12-13
Short Course 1: From Investigator's Brochure to Worldwide Labeling
Short Course 2: Pharmacovigilance Inspections and the Impact on Labeling

*Short Courses require registration and are an additional fee


Labeling is a critical tool for the safe and effective use of prescription and non-prescription drugs, biologics, and medical devices. The labeling conveys the essential information needed by payers, providers, and patients to make decisions about access, prescription, and use of these products. In an environment of increasingly complex labeling requirements, this conference provides a forum for regulators and industry to update their knowledge of local and global labeling-related policies, and to share processes, tools, and approaches to ensure effective and compliant labeling.

This program has been developed in collaboration with the Regulatory Affairs Community-Labeling Working Group.


View Speaker Biographies and Disclosures

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

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 conference, participants should be able to:

  • Discuss new labeling-related developments in Canada, European Union, Japan, Asia, and the US
  • Compare and contrast packaging regulations/guidance among global regions including the US, EU, Asia, and Canada
  • Describe the new US initiatives with structured product labeling
  • Describe the impact of proposed changes to regional and global patient labeling requirements
  • 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 life cycle practices
  • Discuss how labeling groups can work effectively and increase their impact within a variety of organization structures

Program Committee

  • 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
  • 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
  • Barbara  Lachmann, MD
    Barbara Lachmann, MD Senior Advisor, Center of Excellence Product Information
    Barbara Lachmann Labeling Consulting, Germany
  • Megann  Looker
    Megann Looker Regulatory Associate Director Labeling
    Jazz Pharmaceuticals, 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
  • Junko  Sato, PhD
    Junko Sato, PhD Office Director, Office of International Cooperation
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Contact us

Registration Questions?

Send Email
1.888.257.6457
+1.215.442.6100


Agenda Details & Event Logistics

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+1.215.293.5186


Exhibit Information

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+1.215.442.6132


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