Important Guidance & Measures during COVID-19
- FDA Guidance
- FDA Guidance on AE reporting
- EMA Guidance
- EMA Q&A
- EMA Guidance on Remote GCP inspections during COVID-19 pandemic
- European Regulatory Authority Guidance
- ACRO Guidance
- FAGG Guidance in Belgium
- FAGG - Addendum to guidance for Belgium
- Measures for Clinical Trials in Denmark
- Extraordinary measures for Clinical Trials & remote SDV in Denmark
- ANSM Guidance in France
- MHRA Guidance in UK
- NIHR Guidance in UK
- HRA Guidance in UK
- PMDA Guidance in Japan
- MUH Guidance in Spain
- FOPH Guidance in Switzerland
- BfArM Guidance in Germany (Drug Trials)
- BfArM Guidance in Germany (Medical Device Trials)
- Whitepaper German Data Protection Conference (DSK)
- CCMO Guidelines for Restart of Clinical Trials
Slides, Recorded Session and Q&A of the ‘COVID-19 Regulatory Recommendations Summary for Clinical Trials’ Webinar
Important info & useful links on GDPR
- Data Protection Authority (DPA) per Country
- Countries considered ‘whitelisted’ for Data Transfers outside of the EEA
- ITA – EU/US Data Protection Shield
- edpb opinion concerning Q&A on the interplay between CTR and GDPR
- Q&A on the interplay between CTR and GDPR
- Update EU-US Data Protection Shield
- FAQ on the updated EU-US Data Protection Shield
Important info & useful links on MDR and IVDR
General updates & important info in Clinical Research