Survey on Education in Regulatory Affairs - CORE-MD
This short survey assesses what sort of training or education exists within your medical field
and specialty association, to inform healthcare professionals about regulatory
science and affairs, particularly in the context of the EU Medical Device
Regulation.
It will help to identify needs for the development of methodological expertise and educational
requirements for the assessment of high-risk medical devices, in relation to
task 4.3 of the CORE-MD project. The results will contribute to an overview of
educational activities in the field of regulatory affairs, across the major
medical specialties in Europe. It may also be used to advise about training for
members of EU Expert Panels on medical devices.
CORE–MD is a European Union Horizon 2020 project, that will run from
April 2021 until March 2024. It will review methods for evaluating high-risk
medical devices, in order to translate expert evidence into advice for EU
regulators and to recommend an appropriate balance between innovation, safety,
and clinical effectiveness. The BioMed Alliance is a partner in the project.
1.
What is the name of your BioMed Alliance member organisation?
2. Does your society follow developments around regulatory affairs in relation to medical devices? (e.g. around the Medical Devices Regulation) Please provide details.
3.
Does your society organise educational activities on regulatory affairs related to the MDR? (provide examples, details & links where applicable)
5.
Are you aware of other training opportunities for doctors in the field of regulatory affairs for medical devices? (please provide examples & links)
6.
What particular actions would help colleagues in your discipline to develop an interest in regulatory affairs?
7.
Which major training needs do you perceive as necessary to help clinicians better understand the MDR?
8.
Could you please provide us with the name and e-mail address for a relevant contact person within your society that we could follow up with, if necessary?
Thank you for contributing to this survey.
Further details about CORE-MD are available at www.core-md.eu
