President and CEO

Hidetoshi Shimizu, Ph.D. had biopolymer science, graduate school of Tsukuba University in 1980. During working at Fujisawa pharmaceutical company (present Astellas), he got Ph.D. of clinical pharmacology in 1993. At Fujisawa he had engaged research works at pharmacodynamic and pharmaceutical Institute until 1985. After that, he had experienced the R&D project manager of cardiovascular drugs there, coordinating his project teams from preclinical early-candidates throught clinical trials to get regulatory approval more than 8 years. After that he joined Bayer to develop many drugs within Japan, he experienced the positions of regulatory planning manager, clinical research manager and R&D international project manager. He also created the organization of GCP assurance office according to ICH-GCP in 1997 along with a global clinical trainer. In the most recent, he joined medtronic to create the organization of clinical trials according to Japan GCP of advanced medical devices. There two clinical trials of new advanced medical devices were completed by his team, using clinical study results obtained from outside of Japan.

PMDA Updates

J-GCTP regulatory package for regenerative medicine products was isseued in 2014 Japan. Pharmaceutical and venture companies to develop RM products must pay attention to CMC/Quality in particular. I case of regulatory submission or conducting of PMDA strategic meeting for regulatoru science (before starting clinical trials), PMDA will focus on CMC study results /Quality and ask questions in detail.Therefore, we would like to provide suitable consulting services for each client's product based on our intelligence and actual experience. Our technical approach may be Gap Analysis and approach from Japanese Pharmacopeia, etc. so that CMC/Quality study results obtained from outside of Japan would be acceptable by PMDA.

Accomplishment of Pharma Training, Inc.

We had provided the consulting services of Biologics to European Global BioPharmaceutical Company and Japanese venture companies within Japan so far. we intend to provide the services to pharmaceutical companies, healthcare companies and academia focusing on CMC/Quality so that their RM products,etc. can be develoed successfully reducing timeline and costs.

Intelligence Experts of Pharma Training (doctor of pharmacy, doctor of science, doctor of medicine, doctor of engineering, pharmacists, etc. - many experts who had experienced R&D for a long time in major pharmaceutical companies and medical device company.)

Major	Career	Worked for company
GCP clinical trial	Two experts who experienced directors of clinical team at Fujisawa and Shionogi （Pharmacists） One expertwho experienced director of clinical team at Medtronic (Phar. D.)	Fujisawa, Shionogi, Medtronic
Biotech expert of regenerative medicine products CMC and biopharmaceutical products CMC	One expert who experienced a research director of biopharmaceutical products team at Genetech （Pharmacist and Phar.D.）	Genetech
Biotech Expert in US	Aftergraduating Ph.D. science degree at Tokyo University,she engaged a lecturer at Jichi Medical University in Japan.After that,she engaged a research of human gene transcription at Rockefeller University in New York. In the most recent, she joined Sanofi U.S. to develop new drugs as a biotech expert more than ten years. 　　　　　　　　　　　　 (D. Sc.)	Sanofi U.S.
Regulatory Affairs (RA)	Ona project manager who experienced to get regulatory approval of cardiovascular new drugs at Fujisawa more than 8 years (Phar. D.)	Fujisawa
Pharmacology	Pharmacology Director of Central Institute at Japanese major pharmaceutical compnay （Pharmacist、Phar. D.）	Tanabe
Clinical Pharmacology/ Pharmacokinetics in animal	Intelligence expert with high skills who experienced Head of SafetyInstitute at Fujisawa and a Professor at Pharmaceutical University 　　　　　　　　　（Professor, Pharmacist、Phar. D) One pharmacokinetic expert who experienced a laboratory manager at Pharmacodynamic and Pharmacokinetic Institute, Fujisawa 　　　　　　　　　　　　　（D. Sc.）	Fujisawa (present Astellas)
Toxicology	Inteligence expet with high skill who experienced a Director at Safety Institute of Japanese major pharmaceutical company 　　　　　　　　　　　　 （M.D.) 　Pathologist authorized by Japanese Colleage of Veterinary 　 Pathologists	Fujisawa (present Astellas)
Pharmacovigilance (GVP), good postmarketingsurveillance practice (GPSP)	One expert who experienced the responsible preson for Pharmacovigilance at Schring and Medtronic （Pharmacist、Phar. D.）	Schering (present Bayer), medtronic
CMC and pharmaceutical formulation research	One expert who experienced a Director of Development Research Institute at Fujisawa （D.Eng.） One expert who was a laboratory manager at Pharmacodynamic and Pharmacokinetic Institute, Fujisawa （Pharmacist, Phar. D.） One expert who experienced the laboratory manager at Inst. for Solid Physics, Fujisawa/Astellas （D. Sc.）	Fujisawa (present Astellas)
RA for advanced medicaldevices	One expert sho experienced the RA Director at Medtronic （M.D.）	Medtronic

 

Headquater

Kobe Head Office: 6-28-7 Nakamachi, Fujiwaradai, Kita-ku Kobe-city 651-1302 Japan

Company start-up: June 2003