Course Description

European Safety Reporting Requirements during Pre-Market clinical Investigations

Course Description:

This course provides a review of the overall regulatory requirements for adverse event reporting during clinical investigations in Europe, including an outline of the applicable documents and the different reporting requirements for both competent authorities and ethics committees.

This course complies with MEDDEV 2.7/3, MDD, and AIMD requirements.

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Learning Objectives:

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

  • Comply with the EU regulations for adverse event reporting during clinical investigations
  • Implement the EU requirements to company quality system procedures for safety reporting during clinical investigations
  • Set clear timelines for all parties involved in the clinical investigation, particularly the clinical investigators recording, reporting, and reviewing adverse event reporting

Who Should Enroll:

Clinical research associates (monitors), senior clinical research associates, clinical project and compliance managers, clinical quality associates and managers, clinical affairs directors, clinical safety managers, and clinical and regulatory professionals from the pharmaceutical industry wanting to understand the regulatory differences in safety reporting during clinical investigations with medical devices are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • Ethics Committee (EC)/Institutional Review Board Requirements (ID 46)
  • Adverse Event Processes (ID 59)

Subject Matter Expert:
Danielle Giroud

50 min

Related resources:

Case studies:

Basic Account: € 148.00
Premium Account: € 111.00

Last update - 11/07/2012:
The course has been updated according to the new guidance documents.

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