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Privacy laws are changing on the 25th May. Are you ready? On 25th May 2018 the European Union’s new data protection law, the General Data Protection Regulation (GDPR), comes into force with immediate effect and it will have a far- reaching impact on companies...read more
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 use in...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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