This course intends to provide you with:

• Overview and classification of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
• HCT/Ps development and regulatory requirements
• Overview of Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of HCT/Ps
• Overview of FDA’s regulatory approvals process and safety monitoring requirements for HCT/Ps
• Applications of FDA guidance documents and most recent policies/ updates for regenerative medicine and  stem cell technologies in pharmacovigilance 
• Strategies on investigating and reporting adverse reactions related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
• Applicable good manufacturing and good laboratory practices
• Product labeling, marketing and advertising
• Considerations for post-licensure requirements and safety reporting 

At the end of this course, you should be able to:

• Become familiar with different types of HCT/P products and select safety monitoring strategy based on streamline approach and primary mode of action

• Acquire knowledge on Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) as it can contribute to safety of these products due to their specific nature

• Identify applicable regulations and guidelines for safety management throughout lifecycle of human cells, tissues and cellar and tissue –based products

• Develop adverse event reporting systems based on current regulatory guidelines and requirements

• Develop and effectively implement postmarketing safety reporting strategy for HCT/Ps products