The 19th New Pharmaceutical Technology and Engineering Conference 2022 Program
Osaka International Convention Center (Japan) + Virtual Hybrid Conference
Organized by: The New Pharmaceutical Technology and Engineering Institute (NPTE)
July 6th, 2022

July 7th, 2022
（20:30-21:20 EST)

Hirofumi Takeuchi
09:50〜 Chairman, New Pharmaceutical Technology and Engineering Institute(Emeritus Professor, Gifu Pharmaceutical University)
10:00『Opening Remarks』

9:30～
10:20

（21：00-21：50 EST）

Patrik Johansson
Senior Director of Continuous Manufacturing, Manufacturing, Lyndra Therapeutics, Inc『Continuous manufacturing and PAT implementation for the manufacturing of a long-acting oral (LAO)
dosage form』（18：20-19：10 PDT)

Larisa Wu
10:00～ Associate Director, Science and Communications, Office of New Drug Products, Food and Drug
10:50
Administration『Cloud-based Regulatory Assessment: ICH M4Q(R2) and FDA KASA Initiative』

10:20～
Siva Samy
11:10
CEO & Chief Product Strategist, ValGenesis, Inc.
『Digitization of Validation Lifecycle Process - A Necessary Step to Pharma 4.0』

Ying-shu Quan
10:50～
President and Representative Director, CosMED Pharmaceutical Co., Ltd.,
11:40『Latest trends in the development of microneedles』

Koji Muteki
11:10～ Senior Manager, Artificial Intelligence and Digital Technology Gr, Pfizer Global Supply Japan Inc.
12:00
『Pharmaceutical Development and Manufacturing at Lightspeed： Industry-4.0～COVID-19 Pandemic Experience～』

11:40～
12:30

12:00～
12:50

Lunch Time （50 minutes）

Shigetomo Tsujihata
12:30～ Senior Research Scientist, Bio Science & Engineering Laboratories, FUJIFILM Corporation
13:20『Development and prospect of liposomes / lipid nanoparticles manufacturing technologies at
FUJIFILM』

Lunch Time （ 50minutes ）Kazunori Takagi
12:50～ Office of Manufacturing Quality for Drugs, Division of Inspection for Drug II
13:40
Pharmaceuticals and Medical Devices Agency (PMDA)『Current Considerations from GMP/ Review Aspects on Continuous Manufacturing 』

Daisaku Sato
Masayasu Tanaka
Director, Compliance & Narcotics Division, Pharmaceuticals Safety and Environmental Health
13:20～
13:40～ Associate Director, Formulation Research GroupⅢ / Formulation Research & Development
Bureau, Ministry of Health, Labour and Welfare (MHLW)
14:10
14:30
Laboratories / Technology Research & Development, Sumitomo Pharma Co.,Ltd『Regulatory Challages of new GMP regulations and revised Pharmaceuticals and Medical Devices『Development of Blonanserin Transdermal Patch』
Act』
14:10～
Coffee Break （20 minutes）
14:30～
14:30
Coffee Break (20 minutes ）14:30～The New Pharmaceutical Technology and Engineering Foundation
14:50
Particle Design & Research Abroad Grant Awards Ceremony
14:50
The 9th Particle Design Award Commemorative Lecture
Masahiro Niwa
Sanghong Kim
14:50～
14:50～
Associate professor, Dept of Applied Physics and Chemical Engineering
Head, Drug Product & Device Development Japan, Takeda Pharmaceutical Company Limited.
15:40
15:40
Tokyo University of Agriculture and Technology『Contribution of Drug Products to Takeda's Innovative Drug Development』『Statistical modeling methods for robust qulity prediction of pharmaceutical products』（08：40-09：30 CET)

Sunao Manabe
15:40～
Representative Director, President and CEO, DAIICHI SANKYO COMPANY, LIMITED.
16:30『Healthcare in the Society 5.0－ How to create shared value with stakeholders －』15:40～ René Holm
Professor, Department of Physics, Chemistry and Pharmacy, University of Southern Denmark
16:30『Long acting injectables – suspensions – as a means to obtain better treatments for patients』（09：30-10：20 CET）

16:30～ Bernhard Luy
CEO, Meridion Technologies GmbH
17:20
『Spray Freeze Drying – an Innovative Technology Entering Pharma Manufacturing 』

Etsuo Yonemochi
16:30～
Professor, Institute of Medical Chemistry, Hoshi University
16:40『Closing Remarks』