2-day In-person Seminar (December 10-11, 2015)

Regulatory and Development Pathway for Cell Therapies

Cell therapies have been considered as the next generation of healthcare for almost two decades. However, the regulatory and development path of cell-based therapies for many professionals is still unclear. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare. Geron’s halted clinical trial is just one illustration of FDA’s risk-averse stance toward the clinical use of this high risk medical technology.
 
This workshops aims to provide the examples of both failed and successful cell therapy products and trials, to highlight the obstacles in developing stem cell-based or patient-derived cell therapy and to focus on the challenges US FDA faces in regulating these therapies.

Who should attend:
  • Manufacturers of FDA regulated products: Pharmaceutical and Biotech Companies
  • Clinical trial Professionals such as project managers, CRAs, medical writers
  • Senior management for companies developing cell products for US market
  • Regulatory affairs professionals
  • People investing in FDA-regulated products intended for the US market

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: [email protected]