Tag Archives: Clinical Trial

EU MEDICAL DEVICE CLINICAL EVIDENCE 2016/2017

The year 2016 has been a very interesting one from clinical perspective with many developments in the EU medical device regulatory environment, and I am sure we are facing an even more interesting one coming up: The latest draft of … 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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GLOBALIZATION of MEDICAL DEVICE TRIALS: MUTUAL RECOGNITION of CLINICAL STUDY RESULTS

I am looking forward to the International Congress on Clinical Trials for Medical Devices in Berlin later this month, where I will be talking about the globalization of clinical trials and mutual acceptance of foreign clinical data for regulatory and … Continue reading

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WHAT CLINICAL BENEFIT DO YOU WANT TO PROVE IN YOUR STUDY?

Defining the clinical benefit or the efficacy parameters for your product in a clinical study is a challenging but critical activity: Do I aim to show the effect of product itself or that of a treatment as a whole, what … Continue reading

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EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED

Last week Glenis Willmott was announced to be the new rapporteur for the Medical Device Directive revision. For me that raised the question what effect this will have on the clinical research aspects of the proposed Medical Device Regulation. Given … Continue reading

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