4th DIA Cell and Gene Therapy Products Symposium in Japan

Development of gene therapy products is in progress over the world, and the monitoring of efficacy and safety after treatment is extremely important based on the characteristics compared with conventional medicines. It is necessary to consider risk management planning and risk assessment as innovative new drugs. Post marketing surveys as registration of all cases of treated patients are requested in Japan basically. Also, guidance for follow-up of patients administered with gene therapy medicinal products are prepared by both EMA and FDA recently. In this session, DIA invite o the regulators of FDA and EMA and PMDA. They will explain “risk balance on pre-/post- market to treated patients as gene therapy” form point of each health authority’s point of view, including of points on their accelerated review process (BT, RMAT, PRIME, Sakigake). In the panel discussion, two experts will ask them about important points to consider, such as the necessary period of long-term follow up, and the view of the education program for patients and doctors using gene products.