Gene and Cell Therapy Workshop

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PAREXEL

Am Bahnhof Westend 15

14050 Berlin

Program Agenda:

  • Manufacturing challenges for the commercialization of cell and gene Therapy Products
  • Risk-based approach for clinical trials of Advanced Therapy Medicinal Products (ATMP)
  • FDA regulation on biologics including cell and gene therapy products and clinical consideration on treatment of serious conditions with unmet medical needs
  • China: Update on National Medical Product Administration (NMPA) Regulation Reform
  • Logistics challenges and solutions for cell and gene therapy trials
  • Innovative reimbursement models for CAR-T and gene therapies to translate regulatory approval into reimbursement
  • Doctor’s view on how to overcome the bottle-neck in cell and gene therapy 

You can view the detailed program here.

Register here: https://explore.parexel.com/l/563702/2019-09-09/7vrm4q

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