REGULATORY

Regulatory Awareness Training

This training builds basic awareness on regulatory issues and approval pathways related to the development and commercialisation of projects via real live examples and interactive discussions about how to handle and plan those activities during a project.
This four hour introductory course aims at people working in the biomedical and biobased research area.
Course language: English
Next course date: tba
For more information please contact education@chemelot-inscite.com

Medical Devices - CE marking and FDA regulatory approval pathways course

Regulatory approval acceptance for medical devices by notified bodies is a complicated and ever changing challenge. Companies in Europe who plan to bring their developed medical devices to market have to fulfil both product related as well as quality management system related requirements before CE mark or FDA approval can be applied for. This course builds awareness and skills about regulatory pathways as well as development and production related quality system demands for the development of medical devices.
This 2.5 days course is aiming at people working in the biomedical field involved in development of medical devices or coatings for medical device applications. This training is executed by Mikrocentrum.
Course language: English
Next course date: 3-5 October 2017
For more information please contact education@chemelot-inscite.com



Good Clinical Practice Course

Quality of clinical research and adequate reporting of the outcome are crucial for market entry approval of new medical devices by notified bodies of new medical technology. International quality guidelines for performance of clinical trials with medical devices need to be strictly followed. In this course participants will learn the fundamentals of planning, setting-up and execution of clinical trials with medical devices according to Dutch and international law. Furthermore, they will learn about the rights of the patients or volunteers participating in the clinical trials, adequate reporting of results and the responsibilities of researchers, sponsors and other stakeholders in the clinical study.
This 1 day course is aiming at people working in the biomedical field that are actively involved in medical device development for clinical implementation. This training is be executed by CTCM.  
Course language: English
Next course date: tba
For more information please education@chemelot-inscite.com



The Good Clinical Practice course is a good preparation for the eBROKĀ® online training (Basiscursus Regelgeving en Organisatie voor Klinisch onderzoekers) which is offered by the NFU BROK Academy.
 
 
 
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Chemelot InSciTe
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T +31 46 702 28 00, E info@chemelot-inscite.com
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