The MHRA updated its Guidance for industry on flexible approaches to regulation they are taking during the COVID-19 outbreak.
dded information on audits of Notified Bodies and manufacturers in the ‘Medical Devices’ section. Where feasible, audits of Notified Bodies and manufacturers have been delayed. Remote audits and reviews are being considered as alternatives.
Contents
- Making use of regulatory flexibilities
- Clinical trials
- Marketing authorisations
- Pharmacovigilance
- Inspections and good practice
- Blood components for transfusion
- Medical devices
For more details, please see the original communication from the MHRA.
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
Table of Contents
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