• A Review of Upcoming Regulatory Changes Impacting the Medical Device Community

    • On: January 25, 2016 at 03:01PM
    • Category: Conferences

    Topics covered:

    • Adhering to FDA's refuse-to-accept policy
    • Expected changes to 510(k) & De Novo approval pathways
    • The future of companion diagnostics & the impact on the medtech landscape
    • Anticipating an update from the agency on MDUFA reauthorization
  • Navigating the De Novo Pathway – Challenges and Pitfalls

    • On: November 4, 2015 at 08:11AM
    • Category: Conferences

    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

    • On: October 27, 2015 at 08:10AM
    • Category: Conferences

    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

    • On: September 23, 2015 at 09:09AM
    • Category: Conferences

     

    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.

     

The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM