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Global Developmentグローバル開発に関するお問い合わせはこちら

Project Managers -Acquainted with Multinational Studies

PM1

Global Development
Summary of Career
  • She served at local and global vaccine companies, global IVD Company and life science related company. She had been involved in R&D, QA/QC, Regulatory affairs, and has broad knowledge of GLP, GMP and GCP.
  • She has experiences on clinical research in CNS, Urology, Dermatology, Cardiovascular, Oncology and Hematology.
  • She supported to establish Japan subsidiary of Global CRO, and started up their 1st in-house Global study in Japan.
  • After she joined intellim, she has been involved in Global Development, played a key role in start-up of Global Development Department, establishment of Taiwan Representative Office, intellim Korea Corporation and iQ Pharma Services Corporation, and Asian Study Seminar.
  • She has been had very good communication with Upper managements of QPS-Qualitix and QPS Taiwan through partnership agreement and establishment of iQ Pharma Services Corporation (JVC).
Experienced Therapeutic area:
Therapeutic areaIndicationLocal/Global
CNSMajor Depression (2 protocols)Local
UrologyOver-active BladderLocal
DermatologyAcne vulgarisLocal
HematologyHemostatic effect under surgery with pump-oxygenator
Hemophilia B
Global
OncologyBreast Cancer
Renal Carcinoma*
Global

*For Japanese Study manager, she drafted monitoring plan, EDC completion guideline and various manual and format in Japanese. In addition, she established communication line with foreign central laboratory and its courier service.
She had been involved in various feasibility studies.

PM2

Global Development
Summary of Career
  • She had been involved in clinical development at CRO and Pharmaceutical companies
  • Experiences in Monitoring:
    -Monitoring Leader(Japan/Abroad: Phase I ? III)
    -CRA
    -General management of Studies and CRA/CRO as a Playing Manager
    * No findings in written form from PMDA at documents analysis and on-site survey
    Experiences in Project Management:
    -Review of Development Strategy, drafted protocols, responded to inquiries from PMDA, and others
    -Cooperation with head quarters in Europe and US
    * GCP Compliance Survey (Documents and on-site), English, CRO management

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