This training is a 4-hour recorded session, combining the following 2-hour recorded webinars in a package deal with a 50% ‘corona’ reduction on the total subscription fee.
By the end of this TRIUM Training you should be able to:
- Summarize the applicable regulatory framework for medical devices in the EU
- Identify the key changes to the requirements related to clinical investigations today
- Describe the key changes to the ISO 14155 standard and how they align or differ from ICH GCP E6 R2
- Assess the impact of these changes to your daily research reality
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.