There are HCT/P products including combination products that are regulated by the Center for Devices and Radiological Health (CDRH) as medical devices and those that are regulated by the Center for Biologics Evaluation and Research (CBER). For industry to navigate the FDA’s regulatory system to obtain an approval or clearance for HCT/P products, it is imperative we understand the applicable statutory and regulatory requirements and address those requirements satisfactory to the FDA’s expectation.
This conference by expert speaker Dr. David Lim is intended to discuss laws and regulations governing human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). In particular, statutory and regulatory requirements applicable for HCT/P products including good tissue practices (GTPs) will be presented. Dr. Lim will discuss what firms should know about statutory and regulatory requirements to bring HCT/P products to the US market including GTPs, helping you better implement and execute regulatory pathways/options available to the product types. This conference will provide great opportunities to learn about statutory and regulatory requirements applicable for HCT/P products.
Who Should Attend
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.