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Medical Affairs Case Study - Generating Real World Evidence for Medical Device Life Cycle Management



 
Our Price: $395.00

Product Code: WB-7240
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About the Product
Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.


Regulatory agencies and payers are increasingly requiring medical device manufacturers to provide real-world clinical evidence to validate that their marketed devices meet the claims as stated on the indications of use. Generating evidence-based medicine for a 510(k) cleared device assures HCPs of its functionality, allows the manufacturer to validate the indications and assists with managing the reimbursement landscape with payers. Medical Affairs teams have the opportunity to step into the forefront in these efforts to launch a study with collaboration of Clinical Affairs, and work with Managed Markets teams on the strategy to navigate reimbursement. The following case study presentation will examine the development clinical evidence to support the above initiatives:
  • Analysis of the current clinical data and identifying the gaps
  • Pre-trial engagement of KOLs for better strategizing
  • Working with Managed Care teams on timelines and end results
  • The clinical development process
    • Study design and execution
    • Site identification
    • Protocol and statistics
    • Company-sponsored vs. IIR
    • Engaging CROs
  • Life Cycle Management for Optimal Reimbursement
    • Using clinical evidence to support reimbursement
    • Filing and submission process



Speaker:

Deanine Halliman, PhD
Senior Manager of Medical Affairs
Elekta


Participants that will find this webinar most beneficial will be those involved in pharmaceutical, medical device, and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:

  • Medical Affairs
  • Clinical Affairs
  • Medical Directors
  • Clinical Data Management

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