Course Overview

Safety labeling has become recognized as an integral part of a company’s global pharmacovigilance system. As important as for risk-related information is worldwide consistency for usage-related information that serves to ensure a positive benefit/risk balance. This highly interactive conference convenes regulatory/labeling and pharmacovigilance professionals from large and small companies to discuss and exchange experiences in meeting increasingly strict regulatory expectations. Key topics will include the design of the interface between the PV and global labeling process; creation of core safety information and supporting rationales that meet regulatory expectations; specific process features and policies; tracking targets, approaches, granularity and tools; and labeling self-audits.

Benefits of Attendance

  • Interact and learn from industry professionals with recent experience in global labeling compliance
  • Learn through presentations, group dialogue, and panel discussions to gain a well-rounded perspective
  • Meet with exhibitors to learn the latest software and tools to implement for your team

Now available! Discover key topics and planned exercises when you download the current program agenda.

  • Understand the complexities and challenges of global labeling governance
  • Discover safety labeling as an element of a company’s pharmacovigilance system
  • Learn how to measure the performance of a safety labeling system from a GVP perspective
  • Discuss tools to manage the performance of a safety labeling system
  • Identify tools needed for global labeling governance
  • CCDS Process at the HQ Level
  • Interface with PC Processes
  • What to Track, by Whom, and How to Report
  • How to Make Things Trackable
  • Deviation Management – SOPs and Policies
  • Labeling and Regulatory Affairs Professionals
  • Pharmacovigilance (PV) Professionals
  • Professionals Involved in:
    • Regulatory Operations and Compliance
    • PV Compliance and Auditing
    • Global Labeling Governance Initiatives

Course Directors

Dr. med. Leander Fontaine
Principal Consultant
Pharmiceutics, LLC


JP Clement, MD
Pharmacovigilance Consultant
JP Clement Consulting LLC


Julie Retzinger, MBA
Senior Director, Regulatory Affairs Operating Platforms
Astellas Pharma Global Development, Inc.


Course Faculty

Terry Brunone, GlaxoSmithKline
Compliance Director, Global Labeling


Paula Hudson, Eli Lilly & Company
Director, Global Labeling Department


Boris Jankowski, Johnson & Johnson
Transformation Leader, Labeling Management, Regulatory Operations


Barbara Lachmann, MD
Barbara Lachmann Labeling Consulting, Germany


Debra McNaughton, Pfizer, Inc.
Sr. Director, Global Labeling Management


Elizabeth Moyle, Biomarin Pharmaceutical, Inc.
Executive Director, Regulatory Global Labeling


Jan Myers, Celgene
Senior Specialist


Paul Neihouse, PharmD Celgene
Global Labelling, Corporate Operations for Regulatory Affairs


Mary Beth Wilusz, Shire
Director, Global Regulatory Affairs, Labeling

Event Details

Date: October 5 – 6, 2017
Location: DoubleTree by Hilton – Crystal City, Arlington, VA
Course Rate: $1795

This course has concluded. Please check the website soon for Spring 2018 course information.

Course Location

DoubleTree by Hilton
Washington, DC – Crystal City

300 Army Navy Drive
Arlington, VA 22202
(703) 416-4100

Course Information

Lauren Kirk
Course Manager

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