Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) In the US

Date: April 30, 2025
Duration: 60 Minutes
Time: 12 PM EST

Human cells and tissue products are widely used in replacement and regenerative therapies. Recently FDA made a major overhaul in its departments regulating HCT/Ps to match the rapid developments in the medical treatments using such products. The laws governing HCTP/Ps are described primarily in 21 CFR 1271 and PHS 361, however, the laws only provide a general outline and not specific instructions to create and market new products. Since HCT/Ps are allowed to market their products without a formal marketing approval under a BLA provided they need to meet certain conditions that define the quality of the product, labeling and shipping, inter-state commerce and marketing claims. Products that do not meet the strict criteria set by FDA are required to go through the IND and BLA regulatory pathways before being allowed to market. Non-compliance could lead to multiple punitive actions from the FDA starting with Warning Letters, product recalls and withdrawal, restrictions on sales, and even legal action.

This seminar will highlight the key elements of rules governing HCT/Ps using case studies. Practical suggestions for compliance with the FDA requirement along with tips to negotiate with the agency regarding disputes with interpretation of the law will be discussed.

Why should you attend:
If you involved in HCT/Ps, you should be aware of the increased scrutiny from FDA regarding manufacturers in terms of increased audits, Untitled Letters, and product recalls. This seminar will provide a summary of the existing rules, the common complaints from FDA, ways in which companies have tried to comply and practical tips for assuring ongoing compliance status using case studies.

Topics Covered in the Session:

Current regulations for HCT/Ps and review of 21CFR 1271
GMP and GTP for HCT/Ps
Procedures for registration and listing
Common FDA audit findings for HCT/P manufacturing sites
Best practices for addressing audit findings and negotiations with FDA

Who will benefit:

This webinar will provide valuable assistance to all personnel in:

Managers and owners of HCT/P marketing companies
Regulatory and quality professionals working in HCT/P manufacturing sites
Hospital and clinics using HCT/Ps
Regulatory, compliance and quality professionals consulting with HCT/P companies
Medical insurance and reimbursement professionals
Physicians and consumers using HCT/Ps

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.