Tag Archives: clinical studies

CLINICAL EVALUATIONS & CLINICAL TRIALS IN THE EU – TAIPEI

I am very much looking forward to the Medical Device Clinical Trial Regulations and Practice Seminar in Taipei September 5th, where I will be speaking on the current EU standards regarding Clinical Evaluations and Clinical Trials as well as the … Continue reading

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GDPR: DOES IT IMPACT YOUR CLINICAL STUDY?

It is hard to miss, but as of May 25, 2018, the GDPR becomes effective. Although collection and review of personal data and clinical studies have gone hand-in-hand for decades and therefore I do not expect major changes, the devil … Continue reading

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DUTCH HEALTH INSPECTION – THE 4 KNOWS OF THE CONFERENCE ON CLINICAL TRIALS WITH MEDICAL DEVICES

The Dutch Health Inspection (IGZ) organized an invitational conference on clinical research with medical devices end of last year. Representatives of the different stakeholders, such as manufacturers, competent authorities, Ethics Committee’s, and health care providers were present during this conference … Continue reading

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INFORMED CONSENT – 5 CRITICAL ELEMENTS TO MONITOR

Ensuring proper informed consent in clinical studies is a critical process, that protects the rights, safety, and welfare of human subjects involved. It will require even more attention under the new GDPR and with the globalization of clinical trials. Although … Continue reading

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MUTUAL ACCEPTANCE OF CLINICAL STUDY DATA IN DAILY PRACTICE

During the congress on clinical trials for medical devices in Berlin, I spoke on the mutual acceptance of clinical trial data. A short version of my presentation you can find on SlideShare: Globalization of Clinical Trials: Mutual acceptance of Medical … Continue reading

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GENERAL DATA PROTECTION REGULATION – 5 CLINICAL ASPECTS

As mentioned in my previous post on the MEDDEV 2.7/1 revision 4, the second quarter of 2016 is characterized by several big steps from clinical evidence perspective: Besides the publication of the new version of the MEDDEV 2.7/1, consensus was … Continue reading

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