Regulatory Framework for the Digital World

Course Description:

Limitations of data sharing result from the lack of a global regulatory framework. Insights on how data can be compiled into a framework that is interchangeable, while still confidential for clinical trial participants and submissible to regulatory agencies will be discussed. Current approaches to interchangeable data formats (e.g., xml, jpg, mpg, ASCII, etc.), data structures, and blockchain technology will be covered.

Learner Objectives:

• Examine the process of validation and its importance in product development (drug, device, biologic).
• Identify types and limitations of regulatory frameworks (HL7, CDISC) for organizing data.
• Compare and contrast regulatory standards and regulatory frameworks.
• Explore how blockchain technology can be used as a regulatory framework for data sharing, validation, and verification.
• Describe the limitations of cybersecurity.

Course Topics:

1. Validation
2. Common Technical Document (CTD) and electronic Common Technical Document (eCTD)
3. Data Structure and Format
4. Regulatory Framework vs. Standards
5. Information Science (Taxonomy, Ontology)
6. Blockchain Technology
7. Cybersecurity

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
• Review the entire activity
• Complete the quiz and evaluation at the end
• Certificates will be distributed at the end of the evaluation.

• Enduring Materials Dates:
  • Start Date: 5/19/2023
  • Expiration Date: 5/19/2026

Program Information: This is the first course in a six (6) course program. To complete the entire program and earn a badge CLICK HERE.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.