Staying current with regulatory changes is important when it comes to staying out of trouble, maintaining your reputation, and successfully conducting clinical trials. Join Marc Wartenberger, Director Corporate QA & Compliance at CRIO, for a review of new regulations, guidance, and decisions from 2023 that will impact clinical research, including:
- New Part 11 guidance
- FDA DCT guidance
- FDA Patient Diversity guidance
- EU-US Data Privacy Framework
Watch now to:
- Review industry regulations and guidance on Decentralized Clinical Trials (DCT), Electronic Records & Signatures (Part 11), Patient Diversity, and EU-US Data Privacy Framework
- Formulate a plan to avoid regulatory repercussions by preparing for upcoming trial directives and changes that impact clinical research
- Identify strategies to prepare for regulatory changes by adapting your operations
- Get practical advice for how to stay compliant – with real world examples