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What is a Medical Device? This is how the FDA defines a medical device: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: intended for...read more
With all the changes around GCP that have taken place recently a lot of companies and a lot of clinical research professionals are asking the question- Do I have to re take Good Clinical Practice (GCP) training? So how often should we be taking GCP training? ICH...read more
So, as I am sure you are aware by now there has been a recent update to the ICH-GCP guidelines. They are calling this ICH-GCP E6 revision 2 or R2 for short. There hasn’t been an update to the guidelines since 1996 and as you know this was only minor textual changes...read more
Ewelina Testoni, PhD
Fiona Duthie, PhD
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