Course Description

Conducting Medical Device Clinical Investigations in Romania

Course Description:

This course provides an overview of the regulations for conducting medical device clinical investigations in the pre- and post-market phases in Romania. It includes information on required documentation, timelines, fees, and special processes for competent authority and ethics committee submissions, as well as clinical trial insurance requirements and data protection regulatory applications.

Watch the Course Trailer:

 

 


Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Comply with the necessary notification requirements for competent authorities and ethics committees

Who Should Enroll:

Clinical project managers, clinical research associates, and investigators and study coordinators involved in conducting clinical investigations in Romania are all encouraged to enroll in this course.


Prerequisite Knowledge/Requirements:

The following series is required:

  • Medical Device GCP for Investigators (IDs 193, 200, 212, 202, 204, 206)

Subject Matter Expert:
Rolf Marugg

Duration:
20 min

Release date:
10/22/2012

Related resources:
Yes

Case studies:
No

Peer review:
Danielle Giroud

Price:
Basic Account: € 61.00
Premium Account: € 46.00

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