Regulatory Landscape and Practical Challenges in Cellular Therapy

Describes the development, regulatory framework, and safety considerations for HCT/Ps.

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About this Webinar

This webinar describes how human cells, tissues, or cellular and tissue-based products (HCT/Ps) are regulated under 21 CFR 1271. It discusses the origins of Good Tissue Practices (GTPs), the challenges in industrial cell therapy product development, the academic context of cell therapies, and the misconceptions and pitfalls in HCT/P classification. The webinar also includes an explanation of donor eligibility and safety considerations in HCT/Ps.

Release Date: May 14, 2026

Language Availability: English

Suggested Audiences: Academic Medical Centers, Biomedical Product Companies, Blood and Tissue Banks, Faculty, Principal Investigators, Sponsors, Students

Organizational Subscription Price: Included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person


Webinar Content

Regulatory Landscape and Practical Challenges in Cellular Therapy

Presented by: Kathy Loper, MHS, MT(ASCP) - NMDP; Paige McKibbon, MS - NMDP; Angela Ondo, BS, MT(ASCP) - Johns Hopkins Medicine; Damola Ogunleye, MBA - DKO Consulting

Learning Objectives:

  • Discuss the historical development of Good Tissue Practices (GTPs).
  • Identify regulatory differences between 361 and 351 HCT/Ps.
  • Explore the industry challenges in cell therapy product development.
  • Explore the academic institution perspectives on regulatory compliance.
  • Detail the role and application of GTPs in GMP settings.
  • Describe misconceptions and pitfalls in HCT/P classification.
  • Explain the role of donor eligibility and safety considerations in HCT/Ps.

Recommended Use: Required
ID (Language): 22287 (English)


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