2-hr Virtual Seminar: FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
Duration : 2 Hours
Marina Malikova, Executive Director, Boston University School of Medic
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics an Read more
This course offers extensive examination of the FDA’s regulations of biological products such as HCT/Ps from pre-clinical testing to post-marketing regulatory requirements. Specific ethical and regulatory considerations will be discussed for various HCT/Ps.
Course Objectives:
Stem cells have ability to differentiate into numerous cells upon various stimulations. This has led to their wide utilization across several therapeutic areas of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.
This session will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. FDA's regulations and policies updates for regenerative medicine including stem cell treatments, tissue engineering and gene therapies will be reviewed as well as updates on policies regarding regenerative combination products and devices. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress and practical solutions for staying compliant and avoid FDA warning letters during audit.
Course Outline:
• Provide an overview for preclinical and clinical development phase for HCT/Ps
• Discuss fundamentals of HCT/Ps development and regulatory requirements
• Provide an overview for FDA’s regulatory approvals process for HCT/Ps
• Discuss FDA guidance documents and most recent policies updates for regenerative medicine and stem cell technologies
• Applicable good manufacturing and good laboratory practices
• Product labeling, marketing and advertising
• Discuss post-licensure requirements
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Managers and owners of HCT/P marketing companies
• Regulatory and quality professionals working in HCT/P manufacturing sites
• Employees in 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
• Project Managers with little or no HCT/Ps development or clinical trial experience
• Staff from Pharmaceutical Companies or Contract Research Organizations (CROs) involved with the management of clinical trials with HCT/Ps
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
