Pharmaceuticals and Medical Devices Agency (PMDA) and The Japanese Society for Regenerative Medicine (JSRM) jointly convene International Regulatory Forum of Human Cell Therapy and Gene Therapy Products on 16 March 2016 with support from National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN).
This meeting will bring together an outstanding and diverse group of speakers from regulatory agencies (including USFDA and European Medicines Agency (EMA)), industry, and academia, all of whom are at the forefront of the cell therapy and gene therapy field.
We will identify regulatory 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.
Finally, from global point of view, we will discuss specific issues that are to be scientifically aligned internationally among the regulators, while each regulator has flexibility to decide in a case by case basis. We will explore regulatory dialogues and discussions for the future to pursue the data package under minimum consensus for global development of hCTPs.
16 March 2016, 09:30 to 19:30
Osaka International Convention Center, Osaka, Japan
Access : http://www.gco.co.jp/traffic-access/by_transpotation/
For more information, please contact:
Office of Cellular and Tissue based Products, Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan