Greeting -Nobuo Tateishi-
It is my wishes that a Japanese company could manage daily GMP activities under a global level compliance with GXP regulations for the clinical development and/or commercial manufacturing of medical supply, and this is the ultimate goal of NOBBIO CONSULTING. We guarantee an excellent consultation by the qualified staff with abundant knowledge and experiences to provide updated information about recent regulatory practice by authorities such as Japan, Europe and America for prosecution of commercial license applications and also readiness for regulatory inspections.
Profile
Nobuo Tateishi
Personal History
- In 1980 joined Chugai Pharmaceutical Co., Ltd. Worked at USA subsidiary company with responsibility of a liaison of the patent litigation and prosecution of the bioproducts in Europe and USA, and also involved in product development activities for BLA/NDA application. Experiences in various in-house and introduced licensed products development as a project member.
- In 2003 Project leader of the Chugai global QMS system for IMP, working with correspondents at European and USA subsidiary company.
- In 2009 Project leader of global quality assurance system improvement for IMP with Roche/Genentech and inspection management.
- In 2012 Project leader of joint task force with Roche/Genentech Audit functions and traveled around the world jointly with Roche/Genentech as approved auditor to audit manufacturing plants and testing organizations of medical supplies and raw material suppliers.
- In 2017 Joined a National Center of Global Health and Medicine and worked for PJ aiming of investigator initiated clinical trial facilitation and clinical research study promotion based on ICH GCP.
- In 2017 Joined Nexredge Co. Ltd. as a senior consultant. Supported number of domestic and overseas corporations engaging in development of biosimilars, regenerative medicines, nucleic acid medical products.
- In 2019 President and CEO of NOBBIO Consulting LLC.
Membership
- Task force member for revise of Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing with support of a grant for Research on Regulatory Science of Pharmaceuticals and Medical Devices from Ministry of Health, Labor and Welfare of Japan in FY 2010 (Study for Introduction of new analytical method to secure microbial assurance level of pharmaceuticals)
- The GAP analysis working group II member with support of the Health and Labor Science Research in FY 2010 (Study for ensuring international coordination in GMP inspection practice)
- Group leader of Aseptic GMP product committee and QAQC committee of PDA Japan
Publication List (representative)
- 2011
- "Aseptic process assurance under GMP/Pharmacopeia of EU, USA and Japan and Inspections by the authorities " Science and Technology
- "Update of the PIC/S activities and understanding of GMP guidance and inspection" Joint authors, Jyoho Kiko
- 2012
- "Internal audit and self-Inspection under GxP - working practice book" joint authors, Jyoho Kiko
- Point to Consider for manufacturing and quality controls for Bioproducts; joint authors Jyoho Kiko
- 2013
- "Points to consider for warehouse control and distribution/transportation for medical supplies quality - for preparation of inspections under GDP, PIC/S GMP, Japanese GMP " joint authors, Jyoho Kiko
- Understanding the Pharmaceutical Legislation of the European Union, Japan and the United States of America (Focus on Medicinal Products for Human Use), joint authors PDA Journal book 2013
- 2016
- “Aseptic process assurance and validation for injectable products and know-how examples of foreign matter reduction by visual inspection” joint authors, Science and Technology
- 2018
- "Appropriate Quality Assurance for Investigational Medicinal Product (Drug substances) in accordance with the development phase in global development" joint authors, Science and Technology
- 2020
- How to receive marketing approval for Regenerative medical biologics/Recombinantly manipulated Gene therapy products; Point to consider for application review and practical strategy, joint authors Science and Technology
Presentation List (representative)
- 2008
- “Revision of Japanese GMP for IMP”, PDA/FDA joint meeting in 2008 (Washington, D.C)
- 2011
- “Introduction of new Industry guidance 2011 for manufacture of sterile pharmaceutical products by aseptic processing”, GMP forum sponsored by Japan Pharmaceutical Manufacturing Association
- “The Guidance for Industry 2011; Manufacture of Sterile Pharmaceutical Products by Aseptic Processing -(Revised version)”, PDA/FDA joint meeting in 2011 (Washington, D.C)
- 2012
- “New Challenge and Opportunities of PIC/S in EU, USA and Asia”, the 25th Interphex Japan (June, 2012)
- “Comparison of new Industry guideline 2011 for manufacture of sterile pharmaceutical products by aseptic processing with PIC/S Annex-1”, Microorganism forum sponsored by Japan PDA
- 2015
- “The status quo and prospected future of PIC/S GMP/GDP – Global Quality Management Strategy by strengthen audit function" The 28th time Interphex Japan (Tokyo and July, 2015)
- 2018
- “Requirement under global GMP for clinical trial material and effective Quality Assurance System in drug development and commercial license filing stage”, Science and Technology
- 2020
- “How to prepare FDA inspection for data integrity issue”, TH Planning
- 2021
- Guidance for GMP for aseptic products (terminal sterilization vs aseptic manipulation), R&D Supporting Center
- FDA Guidance for Process Validation (Control Strategy and Continuous Process Verification); How to apply lyophilized products, R&D Supporting Center
- Introduction of EU GMP for Advanced Therapy Medicinal Products (Inspection Guidance issued by Swedish Medical Product Agency) Science and Technology
- 2022
- How to cope with revision of EU (PIC/S) GMP Annex 1 (Implementation of Contamination Control Strategy) , CM Plus
- 2023
- How to cope with revision of EU (PIC/S) GMP Annex 1 (Implementation of Contamination Control Strategy) , CM Plus
Contact information
| Mail address | : | tateishinbo@nobbio.net |
|---|---|---|
| Telephone | : | (81)43-286-1557. |
| Office address | : | 2-4-19, Sakushindai, Hanamigawa-ku, Chiba Japan |