Naoki Shukuya

Naoki Shukuya has more than 35 years of expertise in the clinical and regulatory sector. Currently, he leads the development and implementation of clinical strategies to navigate the PMDA and MHLW processes at MCRA Japan. Naoki’s career includes 20 years of experience in the clinical development department of both domestic and overseas pharmaceutical companies as well as 12 years of experience in the clinical and regulatory affairs of overseas medical device companies. In these capacities, he has led teams through clinical development strategies, development of clinical protocols, implementation of clinical trials, and the creation of regulatory submission dossiers. 

Naoki’s areas of specialization are auto-immune disease, organ transplantation, nephrology, ophthalmology and orthopedics in pharmaceuticals, as well as vascular and vein therapies in neurology, cardiology and nephrology in medical devices.