Medical Device versus Drug: Comparing and Contrasting
Medical Device versus Drug: Comparing and Contrasting
To purchase access for your team, or if you have any questions, email us at info@clinicalpathwaysresearch.com.
Course outline HERE
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
Describe key definitions related to drug and device clinical investigations
Learn about the regulatory development and approval process
Identify key differences in safety reporting, IRB duties, and oversight
AUDIENCE
All clinical research personnel
INTERACTIVE DEMO:
