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Generics Labeling 2014

Monitoring Branded Label Changes Effectively to Ensure Successful Generic Label Documentation, Compliance and Safety

3-4 Dec 2014
Inn at Penn, A Hilton Hotel - Philadelphia, PA, United States of America

Why You Should Attend

Generics Labeling 2014

Building on the success of the marcus evans generic pharmaceuticals series, the Generics Labeling 2014 Conference will bring together executives charged with navigating various facets of pharmaceutical labeling and regulatory affairs to increase awareness of safety changes pertaining to the branded drug on Daily Med and the FDA Office of Generic Drugs. This forum will also address the Drug Quality and Security Act HR 3204 (DQSA) which will improve international track and trace practices, allowing increased monitoring of the product to document safety updates faster and ensure compliance on a global scale.

The U.S. Food and Drug Administration (FDA) will soon be issuing a final rule that would allow generic drug makers to follow the same process as branded drug manufacturers in updating safety information on their product labels. Given the variation between the brand and generic label, it makes it even more imperative to remain vigilant about safety updates and Reference Listed Drug (RLD) updates to ensure compliance with FDA guidelines.

Heads, Vice Presidents, Directors and Managers of Labeling and Regulatory Affairs from leading pharmaceutical companies will deliver case studies focused on integrating branded product label changes reported on FDA and Daily Med to ensure generic label compliance, while disclosing pharmacovigilance concerns to regulators to ensure safety and documentation is current in both the branded and generic products.

Key Topics

  • Establish a repeatable label review process in the front end to minimize documentation errors that carry the potential for adverse events
  • Develop track and trace systems to comply with the Drug Quality and Security Act HR 3204 (DQSA) while managing counterfeiting risk
  • Convert Structured Product Labeling (SPL) data into the Physician Labeling Rule (PLR) format to ensure FDA compliance
  • Structure repeatable protocols for the timely notification of new generics-based safety signals to branded drug companies
  • Articulate the impact a global labeling harmonization strategy holds for patient safety and global compliance optimization
  • Previous Attendees Include

    Baxter Healthcare Corporation, Biogen Idec, Eli Lilly, Gilead Sciences, Halozyme Therapeutics, Ipsen Biopharmaceuticals, Merck, Sanofi, Shire Human Genetic Therapies, Takeda Pharmaceuticals USA, Novartis Pharmaceuticals Corporation, Cubist Pharmaceuticals, Inc., EMD Serono, Inc., Pfizer, Inc., Johnson and Johnson, Amgen, and many more!

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    Event Sponsors
    Perigord Group
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    Event Partners

    • BioPortfolio

    • PharmaPhorum

    • PharmaVOICE

    • Generics

    • PharmCast

    Practical Insights From

    Candis Edwards
    Senior Vice President, Clinical Regulatory Affairs
    Amneal Pharmaceuticals

    Christine Simmon
    SVP, Policy & Strategic Alliances
    Generic Pharmaceutical Association (GPhA)

    Tracy D. Rockney, J.D.
    Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence

    Ranjith Abraham
    Sr. RA Labeling Specialist
    Teva Pharmaceuticals

    Regina Frost
    Senior Labeling Specialist, Regulatory Affairs
    G & W Laboratories, Inc.

    Khurram Khan
    Regulatory Affairs Manager
    Blu Pharmaceuticals

    Anna Voght, RAC
    Regulatory Affairs Project Manager
    Perrigo Company

    Click Here For Full Agenda

    Voice of Our Customers
    • "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
    • "Up to date, stimulating and interactive meeting. Enthusiastic audience & high quality speakers." Shire Pharmaceuticals
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    • "The content of the event was very up to date and well explained. Q & A very interactive." 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