• The Physician Sunshine Act: Are You Ready to Report & React?

    • On March 20, 2014 at 08:03AM
    • Categorized in Conferences

    Tracking for the Physician Payment Sunshine Act (the “Sunshine Act”) started August 1, 2013.  How is your company dealing with it?  The Sunshine Act will have a long lasting impact on the way drug and device companies market products to doctors.  Don’t underestimate the complexity of this law and the many granular and specific interpretations it requires for your organization.  Depending on company size, CMS estimates companies will have to spend tens of thousands or even hundreds of thousands each year to comply with the new law.  Those in industry know those are very conservative numbers. Although the law has many critics, it is here to stay.  Marketers and CEOs are trying to decide whether to pivot, or keep doing business the way they have always done.  The demands of the complying with the new law will be expensive and time consuming and require a level of transparency not seen before.  This seminar will help you understand the law, the current implementation interpretations and challenges and will help you prepare for a CMS audit. 

  • Navigating through PMA and 510(k) Submission Processes

    • On February 11, 2014 at 01:02AM
    • Categorized in Conferences

    MD&M holds the largest medical device and manufacturing educational conference in the U.S., and discuss the most important changes that will impact your department over the next 12 months.

  • The Physician Payment Sunshine Act: Are You Ready to Report & React?

    • On February 5, 2014 at 08:02AM
    • Categorized in Conferences

    The Physician Payment Sunshine Act: Are You Ready to Report & React?

    DuVal & Associates and Vector Health 

    Chicago          

    The 1st-half of the program will be devoted to a detailed review of the final regulation and how it applies to your company. Attendees will learn the basics of the Sunshine Act.  Topics include: collection of data, registering your company, reporting (and the exceptions), certification/attestation of data, verification of data with customers, correction of data, creation of an “assumptions” document, among other things.  Importantly, there are many exceptions you need to know about.  Not knowing the exceptions, and how they apply, will put you at a competitive disadvantage in the marketplace. 
                               
  • Navigating the Changing Regulatory Landscape by Forecasting Effects of New FDA Guidances

    • On January 30, 2014 at 09:01AM
    • Categorized in Conferences

    In recent years, FDA has released numerous draft guidances to streamline the review process, elevate the level of scrutiny placed on submissions and ensure the safety and efficacy of devices.

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