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  • Seminars

  • Take a deeper dive into specific topics in consumer healthcare categories. OTC Academy seminars offer a larger group setting with multiple experts who will share knowledge and engage in Q&A with the audience.

    OTC 101 Seminar


    Dietary Supplements Seminar

    A collaborative event featuring updates and insights from FDA and Industry

    Hosted by:
    Dietary Supplements Seminar Sponsors

    May 10, 2017, 10 a.m. – 5 p.m.
    Marriott Bethesda North Hotel
    North Bethedsa, MD

    Seminar Overview

    The Dietary Supplements Seminar is an unprecedented collaboration between CHPA, AHPA, CRN, and UNPA – the trade associations representing the dietary supplements industry. This one-day regulatory seminar will feature updates and insights from FDA and industry regulatory experts, focused on the key regulatory compliance issues facing the dietary supplements industry.

    Who should attend?

    This seminar is open to all. Members of CHPA, AHPA, CRN and UNPA are eligible to receive member pricing. This seminar is designed specifically for manufacturers, marketers, and regulators of dietary supplements focused in the regulatory and quality disciplines.

    Course Level

    Intermediate – For the professional with 3-5 years of experience who has a general understanding of the industry, but wants to learn more about specific topics.

    Seminar Schedule & Topics

    Full Seminar Agenda

    TimeTopic
    10:00 - 10:10 amWelcome and Introduction
    Scott Bass (Sidley Austin LLP)
    10:10 - 10:40 amElements of a Successful New Dietary Ingredient Notification (NDIN)
    Ryan Simon (Intertek) will review the process for preparing an NDIN and provide an example of a recent successful submission to the agency.
    10:40 - 11:10 amFDA Analysis of Trends in New Dietary Ingredient Notifications from Industry
    Cara Welch (FDA) will provide an overview of recent NDI notifications submitted by the industry and discuss the impact of the NDI Draft Guidance.
    11:10 - 11:40 amFDA Update on Adverse Event Report Handling Process and Suggestions for Improvements
    Lyle Canida (FDA) will present on FDA’s handling of adverse event reports for dietary supplements, including a discussion of signal detection methods and how industry can enhance their adverse event submission process.
    11:40 - 12:00 pmBreak
    12:00 - 12:30 pmFSMA Implementation
     Allen Sayler (EAS Consulting Group) will pinpoint elements of FSMA that are important for dietary supplement manufacturers.
    12:30 - 1:30 pmLunch
    1:30 - 2:00 pmFDA Update on Frequently Asked Questions Regarding Changes to Nutrition and Supplement Facts Labels
    A speaker from FDA will answer frequently asked questions pertaining to new Nutrition and Supplement Facts labels including compliance dates, declaration of quantitative amounts of vitamins and minerals, and changes to the definition of dietary fiber.
    2:00 - 2:25 pmFDA Perspective on GMP Inspections
    Angela Pope (FDA) will discuss the agency’s view on inspections including expectations and responsibilities of industry.
    2:25 - 2:50 pmIndustry Perspective on GMP Inpsections
    Will Woodlee (Kleinfeld Kaplan & Becker) will offer an industry perspective on the progress and challenges towards achieving GMP compliance.
    2:50 - 3:10 pmBreak
    3:10 - 3:35 pmFDA Process for Issuing and Reviewing Hold Notices
    Samuel Chan (FDA) will review how the agency handles import detentions and refusals.
    3:35 - 4:00 pm How to Respond to FDA Hold Notices
    Ricardo Carvajal (Hyman, Phelps & McNamara) will discuss what steps ingredient/supplement companies should take when FDA puts a hold notice (i.e., import detention/refusal) on a shipment.
    4:00 - 5:00 pmFDA and Industry Update on Priorities and Opportunities for Collaboration
    This closing panel will feature Steve Tave (FDA) and the heads of the dietary supplement trade associations.
    5:00 - 6:00 pmCocktail Reception

    Registration Information

    $595 – CHPA/CRN/AHPA/UNPA Member pricing
    $995 – Non-member pricing
    $115 – Government

    Register Online
    Registration Form

    Meeting Location

    Bethesda North Marriott Hotel
    5701 Marinelli Road
    North Bethesda, MD 20852
    301-822-9200

    Logistics Information

    Train Information

    • On-site parking is available. The fee is $5 hourly or $15 per day.
    • Amtrak train service is available to Washington, D.C. Union Station (WAS).
    • The taxi stand is located at the front of Union Station outside the Main Hall entrance.
    • Closest metro stop is White Flint Metro Station (red line).
    • Walking directions from White Flint Metro Station to hotel: head south on Rockville Pick toward Marinelli Road, turn right onto Marinelli Road and continue 0.1 mile.
    • Link to WMATA: www.wmata.com.

    Questions

    Jay Sirois Ph.D.
    Senior Director, Regulatory & Scientific Affairs
    202.429.9260
    jsirois@chpa.org

    Registration and Logistics Information

    Shanae McFadden
    Coordinator, Meetings & Education
    202.429.3541
    smcfadden@chpa.org

    Allie Mamone
    Manager, Meetings & Events
    202.429.3544
    amamone@chpa.org

    If you are interested in a private seminar for your company, please contact CHPA’s Britt Wood.

     

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