Training

Open Training: Update on the New ISO 14155:2020 - GCP

September 16, 2020

Date: 16th and 17th of September 2020 

Time: 09.00 until 16.30 CEST time zone (both days)

Location: Amsterdam or Virtual

Language
: English

Costs: € 1350,- ( Early bird € 1250.- valid until 1 August)
       

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 live 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 2020 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 14155-2020

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: June 29, 2020
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