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

    • On June 17, 2015 at 11:06AM
    • Categorized in Conferences

    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?

  • Mobile Medical Apps Webinar

    • On February 17, 2015 at 11:02AM
    • Categorized in Conferences

    How does FDA regulate mobile medical applications? What should companies consider when designing and promoting mobile medical apps?  This program will discuss FDA’s Mobile Medical Applications final guidance.  Topics include the FDA’s regulatory oversight of mobile medical apps, e.g., software used on smart phones, tablets and other devices.  This session will discuss the latest updates from FDA relating to mobile Medical apps.

  • Medical Device and Diagnostic Regulatory Breakout

    • On January 26, 2015 at 01:01AM
    • Categorized in Conferences

    The Food and Drug Administration has openly commented on its objective to become more of a proponent and less of an obstacle for innovative pharmaceuticals and medical devices to enter the marketplace. However, the life science industry still views the regulatory approval process as a difficult path to navigate due to stringent requirements for clinical data, lengthy approval timelines and a lack of transparency from the FDA. To improve the relationship between manufacturers and the agency, a collaborative environment must be fostered through effective communication and an understanding of FDA's plans for transforming regulatory pathways into a catalyst for medical innovation.

  • The Pre-Submission Meeting: Friend or Foe?

    • On November 5, 2014 at 09:11AM
    • Categorized in Conferences

    Device manufacturers, biodesign innovators, regulatory specialists, and academics register now for the 3rd Annual UGA Medical Device Regulations Conference! This conference, cosponsored by the US FDA and the University of Georgia’s Office of BioPharma Regulatory Affairs, will provide educational and networking opportunities to help shape the future of medical device advancement from a regulatory science perspective.

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