International Regulatory Endeavour Towards Sound Development of Human Cell Therapy Products
Date: February 18-19, 2015
Venue: Hitotsubashi Hall
Organized by IABS with the support of Pharmaceuticals and Medical devices Agency (PMDA); Japan Science and Technology Agency (JST); National Institute of Biomedical Innovation (NIBIO); World Health Organization (WHO)
Under the auspices of Forum for Innovative Regenerative Medicine (FIRM); Japan Pharmaceutical Manufacturers Association (JPMA); The Japanese Scoiety for Regenerrative Medicine (JSRM)
Scope and objective:
This meeting will bring together an outstanding and diverse group of speakers from regulatory agencies, industry, and academia, all of whom are at the forefront of the cell therapy field.The major objective of the meeting is to highlight the important regulatory considerations that are unique to human cell therapy products, as well as to promote international dialogue and exchange of information and points of view in this evolving field.The scope of the cell therapy products that will be covered in this meeting are human cell derived and substantially manipulated cell therapy products (hCTPs). The meeting will also identify special points/issues to consider for specific type of products, as well as very critical points/issues for various type of products, which have to be resolved, improved, and/or developed in terms of sound scientific regulation in order to facilitate the availability of products in a rational and timely manner, and which will be valuable globally to public health.