Events

  • Navigating the De Novo Pathway – Challenges and Pitfalls

    Wednesday, November 4, 2015 8:30am - Wednesday, November 4, 2015 9:30am
    Category: Conferences
    Presenter: Mark DuVal

    The Third Annual UGA-FDA Medical Device Conference
    Practical Approaches to an Evolving Regulatory Environment

  • What Management and Marketers should know about the Amarin Off-Label Case & what it means for marketing

    Tuesday, October 27, 2015 8:30am - Tuesday, October 27, 2015 10:00am
    Category: Seminars
    Presenter: Mark DuVal
    Register:

    Join Mark DuVal for a seminar on recent regulatory-related rulings, and the effect they will have on the affected industries.

    Topics to be covered include:

    •  The U.S. Supreme Court speaks Sorrell vs. IMS Healthcare, Inc.
    • The 2nd Circuit weighs in Caronia and Amarin Pharmaceuticals and soon Pacira Pharmaceuticals
    • Where are the FDA and the Department of Justice at in all of this?
    • How do these cases impact government theories going forward?

    and more...

  • CLARIFYING UDI GREY AREAS IN THE UNITED STATES & BEYOND

    Wednesday, September 23, 2015 9:00am - Friday, September 25, 2015 9:45am
    Category: Conferences
    Presenter: Beth Luoma
    Organizer: Q1 Productions

     

    Q1 Productions

    Global UDI Intensive Workshop

     

    Location: San Diego, CA

    Throughout the medical device and diagnostic industries, organizations are currently looking to optimize and leverage investments made in the processes and technologies required to support compliant UDI practices. As many organizations have achieved compliance with FDA UDI standards, executives are now looking towards investments in order to identify areas where data can be leveraged to provide further value across the organization. Many executives are now looking towards international UDI regulations with an aim of streamlining processes and procedures on a global level in order to maintain robust compliance with evolving standards.

     

  • Sunshine Act--How to Avoid Sunburn this Summer!

    Wednesday, June 17, 2015 11:00am - Wednesday, June 17, 2015 12:30pm
    Category: Webinars

    DuVal EDU Regulatory Training presents a 90-minute webinar on the Sunshine Act--How to Avoid Sunburn this Summer!

     

     

    Later this year medical device, drug and biologics executives will be required to attest to the accuracy of their respective sunshine data before submitting it to CMS. Questions that these executives should be thinking about before attesting to the accuracy and completeness of the data submitted include:

    • Are my data sets correct?

    • Are my data sets in violation of applicable laws or our own internal policies?

    • Are we monitoring compliance and violations?

    • How will our customers react if we submit wrong information?

The information on our site is not intended to provide specific legal advice.

Helping clients be appropriately aggressive, yet compliant.™