Seminar Programme
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Conference

Conference 【6A】

Venue: Seminar Room 6A (East Hall 6)
Capacity: 200 Seats ※Pre Registration required
April 17(Wed.)
6A-01
April 17(Wed.)
10:30-11:15

Clinical Development and Deal Trends in the Life Science Industry and 3 Key Implications - Impact from Changes in Values

 

Mr. Itsutaro Imahori

Principal Consultant

Consulting & Analytics

Citeline (Norstella)


Values changing with time is ubiquitous in all societies and holds great impact – even in the life sciences business. In this seminar, Citeline Japan’s (Norstella) Principal share current trends in clinical development and deal activity, and frame the trends from in perspective of “change in values”. Additionally, implications from this phenomenon will be explored based on 3 key predictions.

Closed

6A-02
April 17(Wed.)
11:45-12:30

Explanation of API procurement and contractor selection

 

Mr. SHINYA NAKAGAWARA

General Manager

Quality Assurance Department, Production Division

neo CritiCare Pharma Co., Ltd.


Based on the revision of the GMP ministerial ordinance, I will explain the points to be confirmed in supplier management and GQP audits based on my experience as an inspector of the Kanagawa Prefectural Government, a manufacturing manager of a pharmaceutical factory, and the manager of the quality assurance department of an imported API trading company.

Closed

6A-03
April 17(Wed.)
13:00-13:45

Global Trends and ISPE Endeavors to Prevent Drug Shortage

 

Ms. Ayako Nakajima 

CEO

Q&EHS Solutions Corporation, ISPE Japan Affiliate SAM&GMP COP

 


Focusing on ISPE Guidance for Drug Shortage Prevention Excellence 2023, introduce the recent trends of FDA, EMA, and MHLW toward the prevention of drug shortage, as well as ISPE endeavors in line with these trends.

ISPE Drug Shortage Prevention Model (ISPE DSPM) in the guidance has 12 performance domains to prevent drug shortage.

From these domains, explain recent topics such as Risk Management, Advanced Technology, Evolving Regulatory, Digital Solutions, Regulatory Execution, and Workforce Capability etc.

Closed

6A-04
April 17(Wed.)
14:00-14:40

原薬工場の基本計画時におけるプロセス設計のポイント

 

Mr. Takashi Yahiro

General Manager

Design& Technology Division Engineering Division

CM Plus Corporation


Closed

6A-05
April 17(Wed.)
15:00-16:30
Mr. Satoshi Shiratori
Mr. Akio Watanabe
Mr. Ryo Fujita
Mr. Zenya Arai
Mr. Yukio Ohkawa
Mr. Masato Shirai

Japan Bulk Pharmaceutical Manufacturers Association (JBPMA)

Factory manager/management meeting held by five member companies

-Daily issues in the operation of bulk active pharmaceutical plants-

 

(Moderator)
Mr. Satoshi Shiratori

President & CEO, SHIRATORI Pharmacal Co.,Ltd.

 

(Panelist)
Mr. Akio Watanabe

Corporate officer, Site manager, Chitose site

HAMARI PFST, Ltd.

 

Mr. Ryo Fujita

General Manager, Production Department

JUZEN CHEMICAL CORPORATION

 

Mr. Zenya Arai

General Manager / Factory Manager, Manufacturing Department

SPERA NEXUS,Inc.

 

Mr. Yukio Ohkawa

Chiba Plant, Plant Manager

SHIRATORI Pharmaceutical Co., Ltd.

 

Mr. Masato Shirai

Director, Production Department

KATSURA CHEMICAL CO., LTD.


The panel discussion was management will discuss changes and challenges in the business environment, the impact on the supply chain and how to respond to them, as well as safety and training initiatives.

The discussion will be moderated by Mr. Satoru Shiratori,

President of Shiratori Pharmaceutical Co.,Ltd.

Closed

April 19(Fri.)
6A-13
April 19(Fri.)
10:30-11:15

From Immunogenomics to Immunotherapy

 

Mr. Yusuke Nakamura

President

National Institutes of Biomedical Innovation, Health and Nutrition


With advances in genomics and other various ‘omics’ technologies, it has become possible to continuously capture changes in immune cells in various pathological conditions and drug responses/adverse reactions. The immune responses activated through drug and HLA interaction have been shown to play key roles in drug-induced skin hypersensitivity and hepatotoxicity. In cancer treatment, it is becoming clear that the immune environment within cancer tissues and throughout the body is important not only for cancer immunotherapy but also for the responsiveness of other anticancer drugs and radiation therapy, resulting in development of new types of immunotherapies.

FREE

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6A-14
April 19(Fri.)
11:45-12:30

CDMOを活用した製薬企業の製品開発、協業戦略について:良好なパートナーシップ構築

 

Mr. Masaki Yamada

Technical Fellow

Technology Promotion Division

CMIC CMO Co., Ltd.


FREE

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6A-15
April 19(Fri.)
13:00-13:45

Review on the Next Generation Medical Infrastructure Act

 

Mr. Kazuki Shinkai

Unit chief

National Healthcare Policy Secretariat, Cabinet Office, Government of Japan


FREE

Register
6A-16
April 19(Fri.)
14:15-15:00

Frontiers of the ATLAS Project: Building a robust Asian Clinical Trial Network

 

Mr. Kenichi Nakamura

Director

Department of International Clinical Development

National Cancer Center Hospital


Since 2020, the National Cancer Center Hospital has initiated the ATLAS project to promote drug and medical device development in Asia with the support of AMED. This has led to the establishment of an international clinical trial network encompassing Japan, South Korea, Taiwan, the Philippines, Vietnam, Thailand, Malaysia, and Singapore. This presentation will share the latest updates on the ATLAS project and provide insights into how pharmaceutical companies can leverage the ATLAS network for their benefit.

FREE

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6A-17
April 19(Fri.)
15:30-16:30

Drug discovery for intractable kidney diseases using iPSC-derived kidney organoids

 

Mr. Kenji Osafune

Professor

Department of Cell Growth and Differentiation

Center for iPS Cell Research and Application (CiRA), Kyoto University


iPSC-based disease modeling is a powerful tool for elucidating mechanistic details and discovering novel drugs for numerous intractable disorders. In this work, disease-specific iPSCs genetically predisposed to develop pathology are differentiated into the cells or tissues of interest to recapitulate the disease phenotypes in vitro. In my presentation, I will present the current status and the future ahead for using iPSC-derived kidney organoids for disease modeling and drug discovery to treat intractable kidney disorders, such as autosomal dominant polycystic kidney disease (ADPKD) and Alport syndrome.

FREE

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Conference【4C】

Venue: Seminar Room 4C (East Hall 4)
Capacity: 150 Seats ※Pre Registration required
April 17(Wed.)
4C-01.
April 17(Wed.)
10:30-11:30

CPHI Women

Career Planning for Women in the Pharmaceutical Industry - Why I started my career in research-

Ms. Shinai Sakata

Ms. Toshi Kajiro

Ms. Mariko Mimura

 

 


CPHI Women was launched in 2015 as a co-located event of CPHI Japan as a project to support networking among women working in the pharmaceutical industry, and this year marks its 6th anniversary. How did you advance your career from a research position? How can men and women alike aim for career advancement? Current challenges and solutions will be discussed.

 

Closed

4C-02
April 17(Wed.)
11:45-12:45
Consecutive interpretation

Putting ESG into Practice - Creating Responsible Supply Chains using Common Audit Approaches

 

Ms. Caroline O’Brien,

Global Quality Audit - Hub Director Asia Pacific,

AstraZeneca & former PSCI chair


The complexity and risks found within the global pharma supply chain cannot be understated, and key stakeholders from customers to regulators and investors are increasingly expecting the industry to both manage ESG risks and embed sustainability throughout the value chain. This can only be achieved through industry-wide collaboration that establishes shared frameworks for what a responsible supply chain looks like. The Pharmaceutical Supply Chain Initiative (PSCI) and our membership of 70+ pharma and healthcare companies are leading this collaboration. Through our Shared Audit Program, we are putting ESG into practice and building responsible supply chains.

Closed

4C-04
April 17(Wed.)
14:30-15:15
Mr. Thomas Wicks
Ms. Jacklyn Spedaliere

Operationalizing Clinical Trial Disclosure: Strategies for Compliance and Engagement in the Biopharmaceutical Industry

 

Mr. Thomas Wicks

Head of Transparency Operations

Citeline (Norstella)

 

Ms. Jacklyn Spedaliere

Senior Director, Commercial Strategy & Delivery

Citeline (Norstella)


As regulations for clinical trial transparency evolve globally, trial sponsors face the critical task of implementing effective compliance strategies. This presentation provides insights into navigating the complex disclosure landscape, highlighting best practices for operationalizing transparency requirements. Learn how to leverage expertise and technology to simplify compliance processes while maintaining a competitive edge. Discover strategies for understanding global regulations and adapting to trends to meet evolving requirements. Equip your team with compliance systems to manage new mandates. You’ll leave with actionable insights to manage global clinical trial disclosure through compliance, engagement, and competitive advantage on a global scale.

Closed

 

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