Regulatory Affairs and Quality Advisory Board

In his approximately 25 years in the field, Masahiro has been involved with CMC development, strategic quality planning for CTM production of both sterile and oral-solid dosages, technical transfer managements to U.S. and EU CMOs, preparation of the quality sections of the marketing authorization dossier, and quality assurance for system audits for regulatory compliance and continuous improvement.

Masahiro earned his master's degree in pharmaceutical science (physical chemistry) from the graduate school of the Pharmaceutical Institute, Tohoku University in 1987. He has been a registered pharmacist and an ASQ certified quality engineer.

An active member of PDA for 20 years, Masahiro has been a member of the Board of the Japan Chapter since 2009 and the Annual Meeting Program Planning Committee since 2012. He was instrumental in the arranging speakers for successful collaborative meetings with the PDA-EU Chapter and PDA Global. He is also a member of PDA's Science Advisory Board (SAB), the Aseptic Processing Points to Consider Task Force (2016) and the Sterile Product GMP and development QA committees of the Japan Chapter.

In his approximately 25 years in the field, Masahiro has been involved with CMC development, strategic quality planning for CTM production of both sterile and oral-solid dosages, technical transfer managements to U.S. and EU CMOs, preparation of the quality sections of the marketing authorization dossier, and quality assurance for system audits for regulatory compliance and continuous improvement.

Masahiro earned his master's degree in pharmaceutical science (physical chemistry) from the graduate school of the Pharmaceutical Institute, Tohoku University in 1987. He has been a registered pharmacist and an ASQ certified quality engineer.

An active member of PDA for 20 years, Masahiro has been a member of the Board of the Japan Chapter since 2009 and the Annual Meeting Program Planning Committee since 2012. He was instrumental in the arranging speakers for successful collaborative meetings with the PDA-EU Chapter and PDA Global. He is also a member of PDA's Science Advisory Board (SAB), the Aseptic Processing Points to Consider Task Force (2016) and the Sterile Product GMP and development QA committees of the Japan Chapter.