Training

Public Training: ISO 14155 GCP

December 11, 2019

Date: 11 & 12 December 2019

Location: The Netherlands, Amsterdam

Language: English

Costs: Regular € 1350.-

Introduction

Qserve Medical Device CRO and Consultancy offers you a hands-on GCP course that supports your everyday clinical operations and quality issues. Our course is set up especially for professionals in the medical device industry that work on clinical trials, PMCF studies and investigator initiate trials (IIT), on a regular basis.

During this 2-day course, the content of the ISO-14155 GCP standard for medical devices will be our guide. During the interactive sessions, we will discuss the practical implementation of the standard. The theory will be supported by real-life examples of difficulties and mistakes on the one hand, but also practical and clever solutions that avoid unnecessary bureaucratic burdens on the other hand. At the end of the day, you will go home with knowledge, GCP skills and practical ideas to implement directly within your organization, and you will receive your personal GCP certificate.

NEW! We will also take the opportunity to inform you and discuss the key changes in the upcoming 2019 version of the standard.

Note: this training can also be provided in-house for other organizations in the supply chain involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing or provision of associated activities. The contents will be adapted to the specific role(s) of that organization.

Learning objectives

  • To understand the content and role of the ISO-14155 standard in clinical investigation
  • To be able to implement the standard in a practical way during the preparation, execution and evaluation of clinical studies with medical devices
  • To learn from real-life examples that we come across in our everyday CRO and consultancy practice. Allowing you an exclusive look behind the scenes of several example trials.

Focus points

  • Patient safety
  • Data quality
  • Practical approach
  • Good documentation practice
  • Site selection, communication and collaboration
  • Clinical strategy.

Program overview:

Typical clinical investigation terminology and GCP definitions

Differences and similarities between ISO-14155 for Medical devices, and other GCP standards (e.g. ICH-GCP)

Key changes in the upcoming ISO 14155-2019

Review and discuss the content of ISO 14155 (2011)

Investigator-initiated studies: compliance and value

Practical clinical investigation planning and execution, including real-world examples

Commonly seen pitfalls and how you can avoid them in your trials

Questionnaire and answers

 

Who should attend this course?

Clinical and regulatory personnel working at a medical device manufacturer, who are involved in the preparation, execution or evaluation of clinical investigations with medical devices.

Certification:

Personal GCP certificate.

Trainers:

Loes Pelgrim
Wiebe Postma, PhD
Post date: May 03, 2019
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