Course Description

Introduction to Drug-Device Combination Regulations in Europe

Course Description:

This course provides an in-depth review of the European regulations regarding drug device or drug device combination products. It specifies which directives are applicable and how their interrelationship with combination products should be considered.

This course specifies the involvement of notified bodies and interactions with regulatory authorities and the EMEA, and gives guidance on how to approach different types of borderline situations.

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Learning Objectives:

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

  • Decide which regulations apply to drug device or drug device combination products
  • Know where to find regulatory requirements and guidance documents
  • Plan and process a Medical Evaluation Board (MEB) consultation process
  • Compile a consultation dossier with the NB and MEB

Who Should Enroll:

Regulatory, quality assurance, and marketing managers involved in bringing combination products to the EU market are encouraged to enroll in this course.


Prerequisite Knowledge/Requirements:

The following material is required:

  • The European Union Regulatory System for Medical Devices (ID 145)
  •  Demarcation of Medical Devices to Other Products (ID 75)
  • GHTF/IMDRF - The STED and Its Contents (ID N187)
  • CTD file components

Subject Matter Expert:
Phil Brown

Duration:
55 min

Release date:
01/24/2013

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 162.00
Premium Account: € 122.00

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