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5th Annual Pharma Labeling Compliance

Developing an Agile Labeling Strategy to Accommodate Changes in New Labels, Safety Information, and International Requirements

29-30 Mar 2017
The Hotel Commonwealth | Boston, MA, United States of America

Conference Workshop

Pre-Conference Workshop on March 28: Labeling Intelligence: Mastering Ways to Address and Ensure Compliance with Emerging Regulations with Genentech, Inc.

Conference Workshop

Pre-Conference Workshop on March 28: Synchronizing Core Data Sheets and Core Risk Management Plans (RMP) to Ensure Successful Outcomes Globally with Janssen Research & Development, LLC


Why You Should Attend

5th Annual Pharma Labeling Compliance

Pharmaceutical labeling is an ever-evolving discipline for all labeling and regulatory labeling professionals. Labeling content professionals are looking for innovative strategies to better document, manage, and track core content on a global scale as well as address new requirements that will ultimately facilitate ease of product use and provide more comprehensive information on each label. As the challenge to provide adequate and compliant information becomes more complex and the space within each label becomes more limited, pharmaceutical labeling leaders are looking for solutions to address these challenges.

Key thought leaders and specialists in pharmaceutical labeling from large, medium and small pharmaceutical companies will be brought together in this 5th Annual Pharma Labeling Compliance conference to explore common challenges and emerging regulatory trends. Participants will discuss key strategies for best leveraging information from the core data sheet, mastering label translations, designing through complexities of combination product labels, centralizing labeling through end-to-end tracking, achieving compliance with evolving regulatory standards, benchmarking congruencies in labeling strategies from the medical device industry, implementing human factors and usability data in the label, and remaining vigilant with updating safety information on the label to ensure accuracy.

Key Topics

  • Develop an agile and actionable labeling strategy to prepare for regulatory changes and evolving industry requirements
  • Create a robust end-to-end tracking system to centralize labeling
  • Establish a strategic combination product labeling process to ensure compliant label design
  • Compare & Contrast pharma and medical device labeling to maximize efficiency across industries
  • Incorporate human factors data in the label to improve product literacy
  • Previous Attendees Include

    AbbVie Inc., Allergan, Amgen, Astellas Pharma Inc., AstraZeneca, Baxter U.S., Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Eisai Co., Eli Lilly and Company, Genentech, Inc., GlaxoSmithKline, Johnson & Johnson, Merck & Co., Novartis International, Pfizer, Inc., Roche Pharmaceuticals, Sanofi, Takeda, 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
    Perigord
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    Silver Sponsor
    Intagras
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    Silver Sponsor
    Author-it
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    Silver Sponsor
    Sciformix
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    Panel Partner
    SDL
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    Panel Partner
    Moravia
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    Exhibitor
    Global Vision, Inc.
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    Exhibitor
    Doctor Evidence, LLC
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    Exhibitor
    Vivid Data, LLC
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    Exhibitor
    Reed Technology
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    Exhibitor
    Schlafender Hase
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    Exhibitor
    Indegene
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    Business Development
    TransPerfect
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    Event Partners


    Practical Insights From

    Julie P. Retzinger RN, MBA
    Senior Director, CCDS & Labeling Organization
    Astellas Pharma Global Development, Inc.

    Gerrit Nijveldt
    Senior Director, Regulatory Affairs-Labeling
    Sanofi

    Ingrid Bryzinski
    Senior Director, Strategic Global Labeling Regulatory Affairs
    AbbVie, Inc.

    Seana Hurd
    Senior Director, Quality Systems & Technical Documentation UDI Program Manager
    Intuitive Surgical

    Amy Ebel, PharmD
    Director, Global Regulatory Affairs Labeling
    GlaxoSmithKline

    Kelly M. Treonze
    Director, Labeling
    Merck & Co., Inc.

    Andy Chan
    Associate Program Director, Product Development Regulatory Commercial Labeling
    Genentech, Inc.

    H. Stephanie Bodo Kamga, PharmD. MPA.
    Associate Director, Labeling Strategy, Global Regulatory Affairs
    Shire

    Click Here For Full Agenda

    Voice of Our Customers
    • “Nice Focus on the key issues in portfolio management and resource planning straight from the mouths of the day to day practitioners. Salient and Succinct.” - Schering Plough
    • “The greatest benefit of Marcus Evans conferences is strong representation from Industry and the time set aside for question and answer, Panel Discussions & Networking.” - Abbott Molecular
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    Event Contact

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

    Amanda Pink


    NBC Tower, 9th Floor
    455 North Cityfront Plaza Drive, Chicago
    Chicago, IL 60611

    Telephone:
    312-540-3000 Ext: 6310
    Fax: 312-540-3000 Ext: 6327
    Email: amandap@marcusevansch.com