Medical Device versus Drug: Comparing and Contrasting

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DvD_Full_Thumbnail.jpg

Medical Device versus Drug: Comparing and Contrasting

$199.00

To purchase access for your team, or if you have any questions, email us at info@clinicalpathwaysresearch.com.

Course outline HERE

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INTERACTIVE DEMO AVAILABLE BELOW

This course covers comparing and contrasting medical device and drug clinical trials from an FDA (U.S.-centered) perspective and covering GCP and some global regulatory perspectives.

When visualizing clinical trials, many automatically think about drug studies, especially if that has been their experience. Although there are similarities, there are quite a few differences between medical device and drug or biologic clinical trials, including:

  • Safety reporting

  • Patient populations

  • Trial design

  • Regulatory pathways

  • Postmarket surveillance

Having a good understanding how medical device clinical trials are distinct from drug clinical trials provides a foundation for a successful outcome while protecting participants and data quality.

Course Length: 60 minutes

INCLUDES:

  • Unlimited access to the content for 45 days from your initial day of purchase.

  • Certificate of completion

  • Case Studies

  • Post-Assessment

  • Knowledge Checks

LEARNING OBJECTIVES

  1. Describe key definitions related to drug and device clinical investigations

  2. Learn about the regulatory development and approval process

  3. Identify key differences in safety reporting, IRB duties, and oversight

AUDIENCE

All clinical research personnel

INTERACTIVE DEMO: