Friday, September 13, 2024, 11:00 AM – 3:30 PM CDT
3V. Introduction to Biosafety in the Clinical Setting
Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Advarra, Columbia, MD
The clinical setting poses a different environment than research laboratories. This course provides foundations for applying biosafety concepts in the clinical setting. Course topics include common issues and lessons learned pertaining to clinical facilities including pharmacies, laboratories, clinics, infusion areas, ORs, and waste disposal facilities; PPE, disinfection, risk assessments, and safety practices in the clinical setting; speaking biosafety to doctors, nursing staff, pharmacy staff, infection prevention and control, diagnostic microbiology lab personnel, and hospital EHS staff; applying NIH Guidelines and the BMBL to the clinical setting; gaps in oversight of research safety for clinical trials, and risk assessments for unconventional or highly specialized delivery mechanisms for biologics. The course will conclude with a focus on clinical trials including the role of an IRB and how it can overlap with an IBC; the process for investigational products to obtain FDA approval to be deemed as safe and effective therapeutics; and the evolving regulatory environment in the U.S. for biologics such as vaccines, regenerative medicines, and gene therapy. The course is designed to be highly interactive with discussions, surveys, and group exercises.
Objectives:
- Apply biosafety principles in the clinical setting
- Perform risk assessments and identify gaps in occupational safety in the clinical setting
- Discuss the regulatory oversight structure for clinical trials and the developmental process for investigational products
Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers, Research Administrators, Clinical Professionals
Audience Level: Basic
Course Length: 4 hours (one 4-hour live session with a 30-minute break)
This course has been approved for 0.5 CM points toward RBP/CBSP recertification. *ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 4.50 P.A.C.E.® contact hours. The links to the various invitations for the course will be unique to the user and cannot be shared. The links to the various invitations for the course will be unique to the user and cannot be shared. The links are for single, individual use only. If more than one occurrence of an individual’s name is on the Zoom attendee list or a name not of the roster, all instances will be removed from the webinar with no refund. The webinar and its associated links are for single, individual use only.
To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Confirmed, paid participants will be sent detailed information regarding the course within a few days prior to the course. Substitutions allowed with notice by 8/16/2024. There is a 15% processing fee for cancellations by 8/23/2024. Cancellations between 8/23/2024 and 8/30/2024 will be refunded at 50% of the course fee. No refunds after 8/30/2024.
