Virtual

Event Title

Electronic Systems, Electronic Records, and Electronic Signatures Webinar

April 25, 2023

Date:: April 25, 2023
Time:: 3:00 PM - 4:30 PM ET

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ABOUT THIS WEBINAR

As technology advances, the electronic data flow between systems is more efficient and more prevalent. Understanding the evolving uses of electronic records, electronic systems, and electronic signatures in clinical investigations is important. 21 CFR 11 helps ensure the authenticity, integrity, and reliability of data submitted in support of marketing applications or submissions. In this webinar, FDA will present the current thinking regarding 21 CFR 11 and its application to electronic records, electronic systems and electronic signatures during a clinical investigation.

TOPICS COVERED

Overview of 21 CFR 11
- Scope and application
- Rationale for part 11
Electronic records in a clinical investigation
- Data sources
- Certified copies
- Retention and transmission of electronic records
Electronic systems
- Validation
- Security safeguards
- Audit trails
Information technology service providers
Digital health technologies and data
Electronic signatures

FDA SPEAKERS AND PANELISTS

Introduction
Leonard Sacks, MBBCh
Associate Director
Clinical Methodologies | Office of Medical Policy (OMP) | CDER | FDA

Overview of Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
Elizabeth Kunkoski, MS
Health Science Policy Analyst
Clinical Methodologies | OMP | CDER | FDA

Regulatory Expectations regarding 21 CFR 11 during GCP inspections
Kassa Ayalew, MD, MPH
Director
Division of Clinical Compliance Evaluation | Office of Scientific Investigation | CDER | FDA

INTENDED AUDIENCE

Regulatory science and regulatory affairs professionals working on clinical investigations (e.g., IND, IDE, INAD)
Researchers working on electronic systems that store data for clinical investigations
Consultants focused on electronic records, electronic systems and electronic signatures for clinical investigations (21 CFR 11)
Developers or vendors of electronic systems that produce records for clinical investigations
Developers or vendors of electronic signature services that work with stakeholders involved in clinical investigations

FDA RESOURCES

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

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