Yoshiaki Maruyama | Review Director

Yoshiaki Maruyama, Review Director, Pmda

I am currently a Review Director at the Office of Cellular and Tissue-based Products at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2008, I joined PMDA as an officer in the Office of Compliance and Standards where I was also a secretariat for the Japanese Pharmacopoeia till 2012. I participated as Ministry of Health, Labour and Welfare (MHLW) and the PMDA topic leader for the development of ICH guidelines and Annexes on ?Evaluation and Recommendation of Pharmacopoeial Texts for use in the ICH Regions (Q4B)?. Prior to joining PMDA, I was a research fellow at the University of Calgary, Canada from 2001 till 2005 and National Center of Neurology and Psychiatry (NCNP) Tokyo, Japan from 2005 till 2008.


Day 1: Wednesday 19th May 2021 - Cell Therapy @ 12:00

Keynote panel discussion: How to ensure clinical success

  • Perfecting the art of regulatory submissions from pre-IND to final registration
  • How can we avoid idiosyncratic clinical responses to ATMPs?
  • Renewed guidance: are regulatory agencies changing how they view these approvals?
  • Safety and clinical considerations:Robust, novel pre-clinical models and standardised assaysWhat in vitro tests and animal models can you use to minimise clinical risk?What can you really extrapolate from preclinical investigation to humans?How much should you expand cells? Is a high or low cell dose important?Pharmacogenetics, biodistribution, toxicology.
  • Justification for routes of administration: what do the regulators think about delivery methods?

Day 1: Wednesday 19th May 2021 - Cell Therapy @ 12:30

Roundtable with the regulators: Ensuring clinical success

  • How do we move ahead?
  • Why is it important?
  • What’s the case to be made?
  • Why is it important that we get there?
  • Are there things we can do?
  • Smaller vs larger patient populations

Day 3: Friday 21st May 2021 - Commercialisation, Pricing & Access @ 11:30

Keynote panel discussion: Tackling large-scale, commercial regulatory

·Regulatory harmonisation issues·Covering multiple regions·Aligning regulatory approvals·State of affairs: a lot of modernisation
last published: 10/May/21 08:45 GMT

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