ISCT is pleased to offer a convenient, cost effective way to obtain valuable learning opportunities to those working within the field of cell therapy. With the leadership of two of our committees (North America Legal and Regulatory Affairs Committee and Lab Practices Committee), we are able to offer you interesting topics coordinated by presenters who are equipped with considerable knowledge and expertise in their respective fields.

Although only one audio line and one web connection is allowed per registrant, there is no limit on the number of participants per location. You may invite your colleagues and staff to participate in the webinar by connecting to a speaker phone and projecting the slides on to a large screen using an LCD projector. Prior to the webinar, you will receive an email with instructions on how to join the meeting.

Setting up a Webinar: Technical Requirements

To attend this educational webinar series, you will require access to a computer and telephone. You will need to install WebEx web conferencing software on your computer. Prior to the webinar, you will receive an email with instructions on how to install the software.

Should you have further questions about this event, please email audrey@celltherapysociety.org or call 604-874-4366.

2008 Webinars

Sponsored by the ISCT North America Legal and Regulatory Affairs Committee

Topic: Allogeneic versus Autologous Cell Therapy: Challenges and Differences
Date: Wednesday April 30th, 2008
Time: 12pm - 1pm EDT
Chair: Dr. Grace Kao
Speakers: Dr. Grace Kao, MD, Instructor in Pahtology, Harvard Medical School, Assistant Medical Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute and Olive J. Sturtevant, MHP, MT(ASCP) SBB / SLS, Quality Assurance Manager, Cell Manipulation Core Facility, Dana-Farber Cancer Institute


Learning Objectives:

• Review the common and emerging types of cell based therapy used in autologous and allogeneic settings
• Differentiate the clinical risks associated with autologous and allogeneic products
• Outline the regulatory requirements for autologous and allogeneic products
• Describe the differences in microbial contamination observed in autologous and allogeneic products
• Provide examples of how cell therapy related adverse reactions and deviations are handled in an academic cell processing laboratory

Registration:
IMPORTANT: We currently cannot support toll-free operator assisted lines for International (non-US/Canada) registrants but if you would like to register for the webinar and support your own long distance charges, please proceed with registration and we will provide you with a toll number for your location. As an alternative option, you may purchase the webinar on CD.

Early Registration (Deadline on April 23)
ISCT Member: $75
Non-member: $90

Late Registration (April 24 - April 28)
ISCT Member: $90
Non-member: $105

Please click here to register!
Please click here to order the CD

*Please note that continuing education credits are not available with this webinar.
**Please note that we are unable to offer refunds or cancellations.

Corporate Opportunities

Please click here to learn more about the Corporate Opportunities available with our Webinar. 

Sponsored by the ISCT North America Legal and Regulatory Affairs Committee

Topic:  Cellular Therapy Products: Lot Release Testing
Date: Wednesday March 19th, 2008

Time: 12pm - 1pm EDT

Chair: Dr. Shirley Bartido

Presenters:  Dr. Shirley Bartido – QA Manager, Gene Transfer & Somatic Cell Engineering Facility, Memorial Sloan Kettering Cancer Center and Dr. Adrian Gee – QA Director, Center for Cell and Gene Therapy, Baylor College of Medicine, TX

Learning Objectives:

• Understand the specifications for testing and release for distribution of cellular therapy products as defined in 21CFR 211.165
• Understand the importance and rationale in defining sampling and testing plans as it relates to the type of cellular therapy product.
• Understand the effect of extent of manipulation as seen in 351 vs 361 cellular therapy products on product release testing.
• Understand the role of QA/QC in complying with cGMP during Phase 1 in terms of lot release testing.
• Provide a list of guidance documents that are relevant in establishing the specifications for product characterization and safety testing.

Click Here To Order the CD!

Early Registration (Feb 27 - March 12)

ISCT Member: $75

Non-member: $90

Late Registration (March 13 - March 17)

ISCT Member: $90

Non-member: $105

*Please note that continuing education credits are not available with this webinar.
**Please note that we are unable to offer refunds or cancellations.

2007 Webinar

Topic: Overview of GCP for Cell Therapy

Date: Wednesday November 28th, 2007

Presenters: Victoria (Tory) Lake- RAC, Regulatory Affairs Director, Fred Hutchinson Cancer Research Center, WA and Liz Cardwell- MT(ASCP), RAC, MBA, Principle Consultant, Compliance Consulting, WA

Learning Objectives:

• Understand the roles and responsibilities of the Clinical Investigator
• Understand basic requirements for AE and SAE reporting
• Understand the sponsor-investigator's responsibility to monitor the clinical trial
• Understand the QA/QC requirement applied to Apheresis centers
• Understand the basics of donor eligibility determination and records
• Understand the QA/QC of getting HCT/P to the patient

Purchase the CD!

ISCT Member: $75

Non-member: $90

The CD includes:

•           Webinar PowerPoint Slides

•           PDF Version of the Slides

•           Audio Recording of the Presentation