News
If you are interested in being an investigator on industry-sponsored trials...
On 5 April, two new regulations on medical devices were adopted by the EU namely EU2017/745 and EU2017/746. These replace the existing Directives for Medical Devices and In-Vitro Medical Devices, respectively i.e. 90/385/EEC and 93/42/EEC, 98/79/EC 2010/227/EU.
These regulations were published May 5, 2017 in the Official Journal of the European Union (OJEU) and 'entered into force' occurred on May 26, 2017.
The European Medicines Agency (EMA) have issued a guideline on GCP compliance in relation to the trial master file (TMF), and invites comments from stakeholders. The guideline was compiled by the Good Clinical Practice Inspectors Working Group and the deadline for comments is 11 July 2017.
The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline (published in November 2016).
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