Menu Back toKeynote-Address-1

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

Program Chair’s Lecture: Method of Regulatory Science Promoting Rational Medicine Initiative

Session Chair(s)

Masaru  Iwasaki, MD, PhD

Masaru Iwasaki, MD, PhD

  • Vice President, Head of Center for Advancing Clinical Research (CACR)
  • University of Yamanashi, Japan
It is regulatory authority’s responsibility to deliver a product with innovative medical technology as early and appropriately as possible. Because the innovative medicines often associate with cutting edge technology which has never been experienced, it is necessary to collect all possible worldwide wisdom to evaluate its appropriateness based on the newest regulatory science. In evaluating such new medicine, “Rational Medicine” should always be pursued. Dr. Kondo published his paper called “Rational Medicine Initiative” in February 2017 based on such thoughts. In this session, Dr. Kondo is going to provide an overview of what he was trying to achieve in his 11-year period being the chief executive of PMDA, together with an actual accomplishments, in pursuant to work with key stakeholders in medical institutions, the industry, academia, regulatory agencies to serve patients around the world.


Tatsuya  Kondo, MD, PhD

Medical Innovation strongly based on Rational Medicine Initiative supported by Regulatory Science

Tatsuya Kondo, MD, PhD

  • President
  • SH Medical Excellence JAPAN, Japan