Session Information
AABB Audioconference Series 2012
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The Role of Clinical Trial INDs in Supporting the Biologics License Application
Track
:
Cellular Therapy
Program Code:
124696
Date:
Wednesday, March 7, 2012
Time:
2:00 PM to 3:30 PM
EST
DIRECTOR
:
Ms. Fran Rabe, MS, CQM(ASQ), Director of Quality Assurance, University of Minnesota
MODERATOR
:
David McKenna, MD, Scientific & Medical Director, University of Minnesota
SPEAKER
:
Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC
Description
An IND application is not only required prior to clinical trial, it is fundamental to support a successful future BLA. The IND application, including its clinical and manufacturing elements, must contribute to the product development plan.
While the IND must include the elements specified in 21 CFR 312, selection of effective clinical study parameters will enable compliance with BLA requirements to demonstrate product safety, purity, identity and potency, while allowing the desired product claims.
While the IND must include the elements specified in 21 CFR 312, selection of effective clinical study parameters will enable compliance with BLA requirements to demonstrate product safety, purity, identity and potency, while allowing the desired product claims.
- Describe the role of clinical trial INDs in supporting future BLA submissions.
- Discuss the importance of, and restrictions associated with, product labeling claims.
- Review the significance of IND primary and secondary end points as they related to safety, purity, identity, and potency labeling claims.
| CE Category | CE Value |
|---|---|
| California Clinical Laboratory Personnel | 1.5 |
| California Nurse | 1.8 |
| Florida Laboratory Personnel | 1.8 |
| General Attendee | 1.5 |
| Physician | 1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.
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