Wednesday, October 9 and Friday, October 11, 2024, 11:00 AM – 3:30 PM CDT
7V. Introduction to the Science and Biosafety of Cell and Gene Therapy Clinical Trials
Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Advarra, Columbia, MD
The use of recombinant and synthetic nucleic acid molecules in clinical trials is growing at an explosive pace. This course is intended to introduce biosafety professionals to the science and biosafety of gene-based investigational products in clinical trials including gene-based vaccines, gene modified cellular products, gene therapy and gene editing. This course will provide an overview of molecular biology, virology and viral vectors. Participants will discuss risk assessments and best practices for dealing with risks associated with diverse types of biological hazards.
Objectives:
- Restate the basic molecular biology and microbiological principles behind gene-based vaccines, gene modified cellular therapies and gene therapies
- Summarize how to conduct a risk assessment for gene-based vaccines, gene modified cellular therapies and gene therapies
- Identify viral vectorology (properties, uses, and risks associated with commonly utilized viral vectors)
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals, Research Administrators, Clinical Professionals
Audience Level: Basic
Course Length: 8 hours (two 4-hour live sessions with a 30-minute break each session)
This course has been approved for 1.0 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 8.50 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 9/11/2024. There is a 15% processing fee for cancellations by 9/18/2024. Cancellations between 9/18/2024 and 9/25/2024 will be refunded at 50% of the course fee. No refunds after 9/25/2024.
