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The Use of Mobile Medical Applications as Companions

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Overview 

Continuing Education credits are not available for archived webinars.

This archive will be available for purchase through January 31, 2015.
Broadcast time: 1 hour 30 minutes


The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on September 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and it focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.

This webinar will explore that final guidance, teasing apart exactly what types of apps in the pharmaceutical space will be regulated and which ones will not. Presenters will explore several pre-prepared case studies that focus squarely on the difficult issues associated with applying that guidance to the pharmaceutical use cases. Three commentators will provocatively discuss the different possible interpretations of the guidance as applied to the case studies, and then we will ask the attendees to put the technology at issue into one of the following four categories:

1.  Unregulated mobile app
2.  FDA regulated drug labeling
3.  FDA regulated medical device
4.  FDA regulated medical device constituent part of a combination product

Who Should Attend 

  • Drug Development and R&D Professionals
  • Pharmaceutical and Medical Device and Diagnostics Professionals
  • Regulatory, Clinical and Other Professionals Responsible for Developing Drug/Device Combinations and Companion Diagnostics
  • Regulatory Affairs Professionals

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Discuss the FDA Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff
  • Identify what types of apps in the pharmaceutical space will be regulated and which ones will not

Contact Information 

Printable Registration Form

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Information about this Archive Webinar
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

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Presenter(s) 

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Agenda  

Day 1 Wednesday, Feb 12, 2014

  • 12:00PM - 11:59PM

    The Use of Mobile Medical Applications as Companions

    Speaker(s):

    • Mary Ann Smith
      DRA Policy Head of Medical Device and Combination Products
      Novartis, United States
    • Jafar Shenasa
      Senior Director, Regulatory Affairs
      Proteus Digital Health, Inc., United States
    • William Buras
      Director, Life Sciences R+D
      Tietronix Software, Inc., United States

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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