Decentralised Clinical Trials (DCTs) are here to stay, so now is the time to gain insight into the regulatory landscape to ensure your planning is comprehensive and delivery is efficient.
This first in a series of webinars brings together regulatory, data privacy and security experts to discuss what you need to know to remain compliant.
Attendees will learn the key regulatory and legal considerations related to clinical data generated in DCTs.
This session will cover the following topics:
- The importance of unified terminology for DCTs and current update by the industry
- Regulations and laws impacting DCTs across multiple jurisdictions and countries
- ICH6 –GCP update and revision
- Regulatory GXP rules
- Privacy principles and confidentiality matters
- Data security, ownership, protection, portability, and interoperability
- Case study and lessons learned
Dr Isaac Rodriguez-Chavez (moderator & speaker)
Senior VP, Scientific & Medical Affairs, Decentralized Clinical Trials & Digital Medicine
Executive Director, Head of Regulatory Strategy and Agency Liaison/Global Regulatory Affairs
Executive Director, Change Practitioner/Productivity Ninja Ambassador