A Guide for Successful Cell and Gene Therapy Research
As researchers continue to expand their understanding and potential uses of innovative cell and gene therapies, it’s critically important for all stakeholders to understand how cell and gene therapy differs from traditional drug development.
The steps and processes involved in research, development, and manufacturing, as well as trial execution, may sometimes overwhelm emerging biopharmaceutical organizations already challenged by limited resources. Cell and gene therapy trials may involve additional safety oversight, special infrastructure for product handling, unique patient and participant relationships, and more.
In this webinar, Sharon Ayd, Vice President and Principal, Regulatory Center of Excellence and Daniel Eisenman, Executive Director of Biosafety Services have a thoughtful discussion of the requirements and considerations involved in cell and gene therapy research.
- Identify current regulatory and clinical challenges for cell and gene therapy
- Describe regulatory and manufacturing challenges unique to cell and gene therapy research
- Define biosafety issues associated with conducting cell and gene therapy research
- Outline the broad range of complexity and risks associated with the use of cell and gene therapy in patients
Vice President & Principal
PhD, RBP, SM(NRCM), CBSP
Executive Director, Biosafety Services
Who should watch?
Research professionals involved in research, development and manufacturing of investigational products, as well as planning, conducting, and overseeing research involving cell and gene therapies, including: Investigators and staff at research sites and institutions, sponsor representatives, CDMO representatives, CRO representatives, IRB members and administrators, Environmental Health & Safety and Biosafety professionals
Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.
If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.
Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour