Cell and gene therapy is an exploding area of new technology and innovation in the pharmaceutical industry. Mapping of the human genome that led to discovery of pathways for intervention in disease states drives this innovation in drug development. Many of these discoveries are improving the prognosis of diseases that previously had no therapeutic intervention. As more customized therapeutics and cell-specific therapeutics are developed for use in treating a variety of diseases, FDA Guidance for Industry Documents play a key role. Regulatory expectations are still an important part of the process. These regulatory documents are necessary to ensure quality and safety parameters are established and met. This webinar will address the impact of this new technology and the response of the FDA toward regulating quality and safety.

Background:

Cell therapy and gene therapy is a new technology that is helping patients with previously untreatable diseases. The increase in viable cell and gene therapies necessitated regulatory guidance documents to ensure processes were implemented that assure quality and safety of this new technology. As the landscape changes and new regulations are implemented those who are manufacturing or treating patients with these new technologies should stay up-to-date on recent regulatory changes. This webinar addresses regulatory expectations as well as provides an overview of cell and gene therapy.

Course Objectives:

• Responsible agencies for regulation
• Understanding the drug approval process
• Definition of cell and gene therapy
• Risk assessment
• Implementing processes for safety and quality
• Challenges in characterization of products
• GMP/GLP/GTP

Why Should You Attend:

Stem cells, as well as transfected/transformed cells, are powering significant breakthroughs in medicine. The FDA has been guarded in response to applications for this type of therapy. Due to the need to provide understanding of the regulatory process, the FDA released numerous updated guidance documents. These guidance documents provide information on production through deviation reporting and evaluation of medical devices used in delivery. Companies’ currently developing cell and gene therapeutic agents should take this webinar to gain knowledge to address pertinent issues in manufacturing, assessment, and use of cell or tissue based products.

Course Outline:

• Overview of cell and gene therapy
• Regulatory agency guidelines
• Determining regulatory status
• Minimal manipulation / homologous use
• Process steps
• Critical quality attributes
• Labeling
• Problems and pitfalls
• Deviation reporting
• FDA inspections and enforcement

What You Get:

•  Training Reference Materials
•  Live Q&A with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Research and Development Scientists
• Quality Control
• Quality Assurance
• Regulatory Affairs
• Clinicians
• Compliance Professionals
• Academic Researchers
• Production Supervisors
• Medical Affairs
• Process Developers
• Production Engineers