Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Omni Shoreham Hotel

Sep 12, 2016 7:00 AM - Sep 13, 2016 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Global Labeling 2016

Essential Updates on Worldwide Regulations and Guidelines


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


Want to learn more about Global Labeling 2016? You've come to the right site!



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

Short Course or Primer

To keep you at the forefront.

Sep 11, 2016

Course 1:

From Investigator's Brochure to Worldwide Labeling

Sep 11, 2016

Course 2:

Pharmacovigilance Inspections and the Impact on Labeling

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
  • 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 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
  • Junko  Sato, PhD
    Junko Sato, PhD Associate Executive Director
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Digital Learning Catalog

DIA Learning: eLearning Soultions

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.