Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop (2017)
Chapter: Appendix C: Statement of Task
Appendix C
Statement of Task
An ad hoc planning committee will plan and conduct a 1-day public workshop to examine and discuss challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop will be to learn from existing examples of manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes as well as designing and adhering to standards to help in the navigation of the scale-up process from a research laboratory to the manufacturing environment. Gathering this information will help inform and facilitate future forum discussions around the issues of implementing regenerative medicine therapies and technologies, such as designing and implementing effective manufacturing processes, examining regulatory pathways, and considering bioethical matters. Discussions during this workshop will be held with a broad array of stakeholders which may include research scientists, clinicians, patients, regulators, and representatives from pharmaceutical and biotech companies. The planning committee will develop the workshop agenda, select and invite speakers, and moderate the discussions. Proceedings from the workshop will be prepared by a designated rapporteur in accordance with institutional policies and procedures.
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