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Regulatory & Clinical Aspects of Medical Device Trials    Back

ICR -The Institute of Clinical Research Course Type: Short courses (CPD) Start Date: To be announced
Location: Maidenhead, United Kingdom Duration: Full time - 1 Day Fees/total cost: EUR 765.11 (GBP 567.00)

Description

Run by ICR's medical devices special interest group, this course will define medical devices and describe the differences between device and drug studies. Delegates will be guided through the regulatory and clinical aspects of conducting device studies. The philosophy behind the development of devices and the considerations for the design of device studies will be explored. The course uses trainer input, exercises, and delegate interaction.

 

Who will benefit?

The course has been designed for those clinical research professionals who wish to learn more about device trials. It is of particular benefit to new employees within device companies, those who have worked in drug trials but are new to device trials, and NHS R & D staff interested in device studies.

Outline

  • Types and classification of medical devices

  • Regulations governing medical device development

  • CE marking a device

  • Risk management

  • Role of the competent authority and notified body

  • How device development differs from drug development

  • Clinical evaluation vs clinical investigation route

  • Pre- and post-marketing studies

  • ISO14155

  • Design of device studies

  • Blinding and placebo

  • Randomisation and statistical issues

  • Prospective vs retrospective

  • Registries

  • Issues for drug/device products

  • Approvals process

  • Agreements and finance

  • Product training and accountability

  • Adverse effects & device vigilance

New dates are to be announced. Please see the website for more information.

 

 

Learning Outcomes

 

 

Short courses (CPD) - Full time

Duration:
1 Day
Teaching method:
Face-To-Face
Language:
English
Venue:
Maidenhead, United Kingdom
Standard applicant fee:
EUR 765.11 (GBP 567.00)

LifeTrain

Course contact information

Information Learning ICR
learning@icr-global.org
This course meets 7 out of 9 IMI Education & Training shared quality standards ( Show Details)
  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered
Last update: 02/03/2016
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