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4th DIA Cell and Gene Therapy Products Symposium in Japan

All prices are exclusive of 10% Japanese consumption tax

SESSION 4 - Regulatory Dialog in US, EU and Japan; Risk Balance on Pre/post-market to Treated Patients as Gene Therapy

Session Chair(s)

Masafumi  Onodera, MD, PhD

Masafumi Onodera, MD, PhD

  • Director, Center of Gene Cell Therapy Promotion,
  • National Center for Child Health and Development, Japan
Daisaku  Sato, PhD, MPharm, RPh

Daisaku Sato, PhD, MPharm, RPh

  • Director, Compliance & Narcotics Division
  • Ministry of Health, Labour and Welfare, 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.

Speaker(s)

Wilson W. Bryan, MD

Balancing Benefits and Risks of Gene Therapies

Wilson W. Bryan, MD

  • Director, Office of Tissue and Advanced Therapies, CBER
  • FDA, United States
Patrick  Celis, PhD

Pre- and Post-approval Safety and Efficacy Data Generation for Advanced Therapy Medicinal Products: Experience in Europe

Patrick Celis, PhD

  • Scientific Administrator
  • European Medicines Agency, Netherlands
Megumi  Kawamoto, PhD

Risk Balance on Pre-/post-market to Treated Patients as Gene Therapy in Japan

Megumi Kawamoto, PhD

  • Reviewer, Office of Cellular and Tissue-based Products
  • Pharmaceuticals and Medical Devices Agency, Japan

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