Course Description

Directive 93/42/EEC and update 2007/47/EC: A review for clinical professionals (rev 1.2)

Course Description:

This course lays out the principal sections of MDD 93/42/EEC and its subsequent updates (2007/47/EC) concerning clinical professionals. It offers practical guidance on how to safely and confidently implement MDD requirements to all clinical processes and also includes a section on optimizing cross-functional collaboration between regulatory, quality assurance, and other fields within an organization.

This course details the Directive’s clinical evaluation requirements and highlights the parts that specifically pertain to clinical professionals, such as Article 15 and Annexes 1, 8, and 10.

Watch the Course Trailer:

 

 


Learning Objectives:

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

  • Recognize the Directive’s requirements and definitions of clinical data
  • Interpret the requirements concerning clinical investigations
  • Comprehend and define the Directive’s structure and overall regulatory objectives
  • Identify the details that clinical professionals must know about Directive 93/42/EEC and its subsequent updates through 2007/47/EC

Who Should Enroll:

Clinical research associate (monitors), clinical study coordinators, clinical trial assistants, clinical project and compliance managers, clinical quality managers and associates, clinical investigators, clinical affairs directors, and clinical professionals wanting to learn more about the MDD 93/42/EEC and 2007/47/EC update are all welcome to participate in this course.


Prerequisite Knowledge/Requirements:

The following course is required:

  • The European Union Regulatory System for Medical Devices (ID 145)

Subject Matter Expert:
Danielle Giroud

Duration:
60 min

Release date:
10/19/2009

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 183.00
Premium Account: € 137.00

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