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4th Annual Pharma Labeling Compliance

Optimizing the Labeling Process through Implementing Actionable Strategies that will Achieve Global Compliance and Corporate Goals

15-16 Mar 2016
Boston, MA, United States of America

Why You Should Attend

4th Annual Pharma Labeling Compliance

Pharmaceutical labeling is a constantly evolving and complex discipline for all labeling professionals. Not only are there emerging new regulations that pharmaceutical and generic pharmaceutical companies need to comply with, but when submitting their labels to FDA or EMA there are always different items to document per regulation they are adhering to. Via case study presentations and panel discussions, the conference delegation will coordinate a more robust End-to-End Labeling process while adhering to new guidance’s such as the Pregnancy & Lactation Labeling Rule (PLLR) and new guidance’s with submitting Combination Product labeling.

This conference brings together highly specialized professionals working in labeling from drug companies. Participants will discuss key strategies for attaining efficiency in designing a product label inclusive of core content, confronting stringent timing constraints, translation challenges and adhering to changing FDA guidelines and standards.

Key Topics

  • Develop an End-to-End Labeling model that will improve the entire labeling process
  • Deal with errors that occur when submitting labels in Structure Product Labeling (SPL) Format to achieve compliance with FDA standards
  • Remain vigilant with product safety changes to ensure the label is accurate and depicting all safety information
  • Devise a labeling alignment model that will assist in achieving global labeling harmonization
  • Identify and document branded and generic label updates to ensure compliant product labeling
  • 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.

    Practical Insights From

    Andrew Friedman, M.D.
    Head and Senior Director, Global Labeling Center of Excellence
    Janssen Research & Development, LLC

    Gerrit Nijveldt
    Senior Director Regulatory Affairs - Labeling

    Gil Granados
    Director of Global Labeling
    Amgen, Inc.

    Michelle L. Halliez
    Director, Global Regulatory Operations & Strategy Planning
    Bristol-Myers Squibb

    Preeti Singh
    Senior Manager, Regulatory Global Labeling, Global Regulatory Affairs - Development

    Mauricha F. Marcussen
    Program Manager

    Lang Naraski, Pharm.D
    Senior Specialist Global Labeling Compliance, 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:

    Tyler Kelch

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

    Fax: 312-894-6304