Central Virginia Chapter: FDA/MHRA Workshop on Data Integrity
Speaker Names:Nancy Boxx, Director of Quality Assurance
Atlantic Research Group
Jennifer Stanislawski, Quality Assurance Auditor II
Atlantic Research Group
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Program Description:This workshop will provide an overview of US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Medicines and Healthcare products Regulatory Agency UK (MHRA) perspective on the importance of quality management practices for data integrity. It will provide regulatory perspectives (as part of cooperative law enforcement or cooperative regulatory activities) on data management, data blinding vs unblinding, and the roles played by QMS vs QbD vs Risk Based Assessments in Data Reliability in global clinical trials.
Program Agenda:
5:30 – 6:00 pm – Registration & Networking
6:00 – 6:45 pm – Educational Presentation
6:45 – 7:00 pm – Question & Answer Period
7:00 – 7:15 pm – Networking 1:1 with speakers
7:15 – 7:30 pm – Wrap Up and Close
Learning Objectives:
- Understand the background of the FDA MHRA collaboration
- Define Data Integrity
- Give examples of differences in FDA and MHRA Inspections
- Define vendor management
- Understand issues involved in clinical trials with a blinded design to avoid bias.
Further Information:
Education Committee Member
Christina Ludwick
Christina@VirginiaStudy.com
804-401-7461
Registration Cost:
- ACRP Local Central Virginia Chapter Members = $10.00
- ACRP Members = $10.00
- Non ACRP = $20.00
Contact hours: 1 ACRP contact hour has been approved through ACRP. Membership is not required for online registration of contact hours.
Contact Hour cost (this cost is in addition to the event registration fee):
- ACRP Local Central Virginia Chapter Members = Free
- ACRP Members = $15.00
- Non ACRP = $30.00
Refund Policy: There are no refunds unless the program is cancelled by the chapter before the start of the program.