The EU Clinical Trial Regulation 536/2014 is ready and it’s anticipated that it will become law in the member states as of November 2018, replacing the ‘GCP’ Directive 2005/28/EC. ISO 14155, the ‘GCP’ for medical device trials will be updated by 2019.
This live online TRIUM Session will provide an update of the expected changes and how they will affect pharma and medical device trials.
At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.
By the end of this TRIUM Training you should be able to:
- Describe the differences between the EU ‘GCP directives’ and the EU Clinical Trial Regulation 536/2014
- List the expected changes to the ISO 14155 standard
- Describe how these changes affect your role in clinical research
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.