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2nd Annual Pharma Labeling Compliance

Establishing Strategic Labeling Practices to Meet Current FDA Regulations and Work Towards Operating on a Global Scale

19-20 Mar 2014
Hilton Boston Back Bay - Boston, MA, United States of America


Why You Should Attend

2nd Annual Pharma Labeling Compliance

Chairperson:
Kathleen M. Bulgreen
Associate Director, Global Labeling, Regulatory Affairs
Eisai


The 2nd Annual Pharma Labeling Compliance Conference will bring together leading global labeling and regulatory affairs professionals to exchange innovative strategies for complying with constantly evolving FDA regulations and remaining competitive in the global marketplace. By attending, delegates will discover proven solutions to industry challenges including managing submissions to facilitate label approval and integrating global regulations to achieve harmonization on an enterprise level.

Industry leaders will be afforded with the opportunity benchmark and network with speakers and their peers who are dealing with many of the same issues involved with labeling compliance. Attendees will benefit from highly interactive case studies and panel discussions, 10-15 minutes of Q&A time following each presentation, 4+ hours of networking opportunities, and online access to speaker presentations post-event.

Key Topics

  • Work with global affiliates during label development to prevent deviations
  • Frame agile and repeatable approaches to promote efficiency in the development and management of core data sheets
  • Keep up with FDA regulations to ensure continued compliance
  • Integrate global regulations into core data sheets to accelerate the approval of local labels
  • Identify key regulatory differences to establish a global perspective when developing core data sheets
  • Previous Attendees Include

    AbbVie Inc.
    Actelion Pharmaceuticals
    Allergan Inc.
    AstraZeneca
    Biogen Idec
    BioMarin Pharmaceutical Inc.
    Boston Scientific
    Bristol-Myers Squibb
    Celgene Corporation
    Eisai
    GlaxoSmithKline
    Millennium: The Takeda Oncology Company
    Pfizer Global Quality Operations
    Sanofi US
    Vertex Pharmaceuticals


    Why Choose marcus evans?

    marcus evans specialises in the research and development of strategic events for senior business executives. From our international network of 63 offices, marcus evans produces over 1000 event days a year on strategic issues in corporate finance, telecommunications, technology, health, transportation, capital markets, human resources and business improvement.

    Above all, marcus evans provides clients with business information and knowledge which enables them to sustain a valuable competitive advantage and makes a positive contribution to their success.


    Event Sponsors
    Silver Sponsor
    QuickLabel Systems
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    Silver Sponsor
    Intagras
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    Silver Sponsor
    PRISYM ID
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    Silver Sponsor
    Sciformix
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    Silver Sponsor
    Loftware
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    Drinks Reception Host
    Global Vision
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    Exhibitor
    Doctor Evidence, LLC
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    Exhibitor
    Glemser Technologies
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    Event Partners

    • BioPortfolio

    • BioSpace

    • ComplianceOnline

    • Label

    • Labels

    • pharmaphorum

    • PharmaVOICE

    • RAPS


    Practical Insights From

    Karen Riddick
    Director, Regulatory Affairs Labeling
    Shire Pharmaceuticals

    Dora W. Cohen
    Executive Director, Global Labeling
    Amgen

    Roya Behbahani, PharmD, MBA
    Senior Director, Labeling Strategy
    GlaxoSmithKline

    Vijay Sammeta
    Director of Global Regulatory Affairs, Labeling
    Sanofi US

    Ilze Kurins Antons
    Senior Director, U.S. Regulatory Affairs
    Lundbeck

    Deb McNaughton
    Senior Director, Global Labeling Management
    Pfizer

    Elizabeth Moyle
    Director, Regulatory Affairs - Labeling
    BioMarin Pharmaceuticals

    Linda Pollitz
    Director, Regulatory Affairs, Advertising and Promotional Labeling
    Alkermes

    Click Here For Full Agenda

    Voice of Our Customers
    • “Great selection of speakers and uniformly high quality presentations. The intimate nature of the meeting provided excellent networking opportunities.” – AbbVie Inc.
    • "Vital information for anyone involved in labeling compliance." - Takeda
    • “Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis
    • "I continue to be impressed by the quality of speakers and depth of content at each marcus evans event." - AstraZeneca
    • "Current, stimulating, and interactive meeting. Enthusiastic audience and high quality speakers." - Shire Pharmaceuticals
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    Event Contact

    For all enquiries regarding speaking, sponsoring and attending this conference contact:

    Robin Yegelwel


    455 N. Cityfront Plaza Dr.
    9th Floor
    Chicago, IL 60611

    Telephone:
    (312) 894-6306
    Fax: (312) 894-6304
    Email: robiny@marcusevansch.com