UTILIZING RISK ASSESSMENTS TO DETERMINE ADEQUATE LEVELS OF ON-SITE & REMOTE MONITORING

PRODUCT INFO

Includes 50 minute Windows Media Video File and PowerPoint presentations for immediate download.

About the Product
Includes 50 minute Windows Media Video File and PowerPoint presentations for immediate download.

As clinical studies continue to multiply in complexity and cost, complete on-site monitoring and surveillance has become more expensive and proven inefficient. In response, manufacturers have added additional provisions to clinical protocols by including remote monitoring, which allows clinical executives to better manage both time and monetary resources while promoting safety and efficiency. In order to utilize a variety of monitoring schemes effectively, a clinical risk-based assessment is crucial and should be included in monitoring planning prior to the start of a study and adapt as the trial evolves. A greater understanding of risk-based assessments will help the industry successfully prepare for and execute risk-based monitoring plans for on-site and remote locations.

  • Overview of the requirements for risk-based monitoring
  • Risk-based monitoring methodology development and application
  • Comparing risks associated with on-site versus remote monitoring


Speaker:
Irfan Khan
Operations and Outreach Lead Consumer Safety Officer
Office of Compliance, DBM | OC | CDRH | FDA

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

  • Clinical Research
  • Clinical Affairs
  • Clinical Operations
  • Regulatory Affairs

Brooke AkinsContact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 
bakins@q1productions.com