Laws and Regulations

Zika Virus: Donor Screening and Handling CT Products in the Face of Emerging Viruses eCast (AABB Center for Cellular Therapies), September 21, 2017-September 21, 2019 
Description: Live and On-Demand eCast. Newly emerging viruses, such as Zika virus, are a threat to the blood supply as well as autologous and allogenic cellular therapy products collected for use in transplants. Understanding the risk of Zika virus transmission, current donor testing and screening, and the regulations which help to prevent transmission are critical for patients undergoing cellular therapeutic procedures. The presenters will discuss current strategies used in collection facilities and stem cell laboratories to help mitigate the Zika virus outbreak.

Significant Changes to the 8th Edition of Standards for Cellular Therapy Services On-Demand eCast (AABB Center for Cellular Therapies), June 21, 2017-June 21, 2019
Description: This program introduced the AABB 8th Edition of Standards for Cellular Therapy Services. The speakers will summarize the new and revised requirements incorporated into the 8th edition of Standards. These changes include the expansion of informed consent requirements, the addition of a standard to respond to emerging infectious diseases, and the implementation of ISBT 128 labeling of cellular therapy products. In addition, the rationale for the changes will be reviewed.

Regulatory Obligations for Investigator-Sponsored Research (FDA OCTGT)
Description: Pat Holobaugh discusses the regulatory requirements for an investigator who is also a sponsor of an IND or IDE.

Early-Phase Trials of Cellular and Gene Therapies (FDA OCTGT) 
Description: Steve Winitsky discusses the clinical risks of cellular and gene therapy products, and reviews some considerations for the design of early-phase trials of these products.

Pediatric Clinical Trials (FDA OCTGT) 
Description: Steve Winitsky discusses the regulation and design of pediatric clinical trials.

Fast Track (FT) for Products Regulated in OCTGT (FDA OCTGT)
Description: Bindu George discusses Fast Track requests and designation for OCTGT products, including cellular and gene therapies.

IND Safety Reporting (FDA OCTGT) 
Description: Bindu George provides basic information regarding the FDA safety reporting requirements for INDs.

IND Basics in OCTGT (FDA OCTGT)
Description: This presentation looks at the basics of IND submission in OCTGT.

Preparing for a FDA Inspection (PACT)
Description: This webinar provides an overview of FDA inspections, tips for preparing for an FDA inspection, and inspection/facility notification case studies.

Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products (FDA OCTGT)
Description: This presentation aims to guide manufacturers toward successful development of quality cell and gene therapy products.

Cellular Therapy Products (FDA OCTGT)
Description: This presentation discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.

The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND (FDA OCTGT) 
Description: In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials.

FDA Presents: Using Donor Screening and Testing to Determine (FACT), March 5, 2015
Description: This webinar was live on March 5th, 2015, by Safa Karandish, FDA Consumer Safety Officer. Karandish gave clarification regarding the actual requirements about determining donor eligibility. She briefly reviewed the requirements and gave examples to accompany them.

FDA Licensure of HPC, Cord Blood: How Licensure Has Improved Cord Blood Banking (Save the Cord Foundation), April 2015
Description: Watch the recorded webinar to hear Sharon Miller, Director of Regulatory Affairs at ClinImmune Labs, speak about the positive effects of FDA licensure on HPC, Cord Blood, and how licensure has improved cord blood banking.