marcus evans north america conferences

3rd Annual Pharma Labeling Compliance

Deconstructing Global and Local Labeling Regulations to Develop a Cohesive and Robust Compliance Strategy

25-26 Mar 2015
Le Méridien Cambridge-MIT, Cambridge, MA, United States of America

Conference Workshop

Understanding the Basics of Labeling to Ensure Labeling Compliance

Pre-Conference Workshop March 24, 2015

Workshop Moderator: Hayley Parker, Associate Director, Regulatory Global Labeling

Company: Biogen Idec

Why You Should Attend

3rd Annual Pharma Labeling Compliance

Conference Chairperson:

Mauricha F. Marcussen
Program Manager, Global Labeling, Ad Promo, Operations and Compliance
AbbVie Inc.

Now in its third year, the marcus evans Pharma Labeling Compliance Conference provides an invaluable forum for global labeling and regulatory affairs practitioners to benchmark their compliance strategies against their peers and discover how others are leveraging best practices to ensure their internal processes operate effectively and efficiently.

This conference will deliver 15+ industry-specific case study presentations on the latest trends in pharma labeling compliance, including recent FDA labeling regulations, SPL, CCDS, TPPs, social media advertising, and challenges with label safety. Attendees will benefit from Q&A time following each presentation to ensure their specific labeling challenges are addressed, 4+ hours of networking opportunities, and exclusive online access to speaker presentations post-event to reference back at the office.

Seating is limited to maintain an intimate conference environment that will cultivate the knowledge of all participants. Inquire today to ensure availability!

Key Topics

  • Deconstructing FDA requirements for structured product labeling (SPL) to ensure labels comply with U.S. compliance standards
  • Managing safety information within a label to meet FDA standards for labeling compliance
  • Developing core data sheets for global and local submissions to promote labeling compliance
  • Utilizing target product profiles (TPPs) as a tool to establish future labeling components
  • Realizing challenges in social media advertising from the labeling operations perspective
  • Previous Attendees Include

    AbbVie Inc.
    Astellas Pharma Inc.
    Baxter U.S.
    Biogen Idec
    Boehringer Ingelheim
    Bristol-Myers Squibb
    Celgene Corporation
    Eisai Co.
    Eli Lilly and Company
    Johnson & Johnson
    Merck & Co.
    Novartis International
    Pfizer, Inc.
    Roche Pharmaceuticals
    Vertex Pharmaceuticals
    ... and many others!

    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
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    Silver Sponsor
    ArborSys Group
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    Silver Sponsor
    Perigord Group
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    Doctor Evidence
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    Event Partners

    • PharmaPhorum

    • PharmaVOICE

    • pharmaceutical

    Practical Insights From

    Tracy Rockney, JD
    Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence
    AbbVie Inc.

    Andrew Friedman
    Head, Global Labeling
    Janssen, Pharmaceutical Companies of Johnson & Johnson

    Shimon Yoshida
    Senior Director, Head of International Labeling Group
    Pfizer Inc.

    Beth A. Lage, RAC
    Associate Director, Global Regulatory Affairs, Regulatory Operations and Compliance - Labeling
    Baxter Healthcare Corporation

    Jason Canale
    Director, Labeling Commercial Operations
    Otsuka Pharmaceuticals

    Colleen McGraw
    Director, Global Labeling
    Cubist Pharmaceuticals- a wholly owned subsidiary of Merck Pharmaceuticals

    Beata McCormack, PharmD
    Associate Director, Global Regulatory Affairs

    Click Here For Full Agenda

    Voice of Our Customers
    • "Absolutely wonderful event focused on strategies and issues directly influencing the pharmaceutical industry." - Celgene Cellular Therapeutics
    • "The greatest benefit of marcus evans conferences is strong representation from the industry and the time set aside for Q&A, panel discussions and networking." - Abbott Molecular
    • "Up-to-date, stimulation and interactive meeting. Enthusiastic audiance and high quality speakers." - Shire Pharmaceuticals
    • "The content of the event was very up-to-date and well explained." - Teva Pharmaceuticals
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    Event Contact

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

    Abby Wilson

    The NBC Tower, 9th Floor
    455 N Cityfront Plaza Drive

    (312) 894-6313
    Fax: (312) 894-6304