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申込者情報の入力

Keynote/ Special Seminar

Keynote Seminar

Venue: Keynote/Special Seminar Room K, East Hall 3
Capacity: 600 Seats Free of Charge ※Pre Registration required
March 18(Mon.)
K-1
9:15
|
10:30
Current topics regarding regulation of pharmaceuticals in Japan
Mrs. Yamamoto Fumi,
Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Director,
Ministry of Health, Labour and Welfare (MHLW)

【Venue : Keynote/Special Seminar Room K, East Hall 3】
Closed

March 19(Tue.)
K-6
9:30
|
10:30
Simultaneous interpretation
Current issues of pharmaceutical industry and its future direction
Dr. Isao Teshirogi,
President, The Federation of Pharmaceutical Manufacturers’ Associations of Japan(FPMAJ),
Vice President, The International Federation of Pharmaceutical Manufacturers & Associations(IFPMA),
President, CEO, Shonogi Co.,Ltd.

【Venue : Keynote/Special Seminar Room K, East Hall 3】
【Language: English/ Japanese】

The pharmaceutical industry contributes not only to the extension of healthy life expectancy but also to the development of economy and science and technology through the creation of new drugs. As the productivity of drug discovery is declining, some analysis of the reasons and possible countermeasures to promote innovation, such as improving efficiency and speed of research and development, and appropriate system for evaluation of value of new drugs, are presented.
Closed

March 20(Wed.)
K-11
9:30
|
11:00
Dr. Shingou Sakurai,Ph.D.
Mr. Akihiro Nagaoka, MBA
Mr. Kazuhiro Okochi,
Dr. Junko Sato, PhD
1. PMDA’s International Strategic Plan in GMP Area (Towards hosting PIC/S Japan 2019)

2. APAC’s challenge “To expedite the launch of innovative medicines for the peoples in Asia”

3.International cooperation and collaboration in Asia from the viewpoint of Quality and GMP (industry's activities)

4. Panel discussion
1.
Dr. Shingou Sakurai,Ph.D.
PMDA, Senior Director (for Manufacturing/Quality and Compliance),
Pharmaceuticals and Medical Devices Agency (PMDA)

2.
Mr. Akihiro Nagaoka, MBA,
Chairman, Asia Committee, Vice Chairman, International Affairs,
Japan Pharmaceutical Manufacturers Association
Staff Executive Director, External Relations,
Astellas Pharma Inc.

3.
Mr. Kazuhiro Okochi,
Associate Director,
Quality Services & Improvement, Commercial Quality, Japan Quality, Global Quality,
Takeda Pharmaceutical Company Limited,
Chairperson, GMP Expert Committee, Quality & Technology Committee,
Japan Pharmaceutical Manufacturers Association (JPMA) 

4.
Moderator: Dr. Junko Sato, PhD,
Office of International Program, Office Director,
Pharmaceuticals and Medical Devices Agency

【Venue : Keynote/Special Seminar Room K, East Hall 3】

1.
PMDA has established International Strategy Plan 2015 and conducted multilateral international activities.  In the framework of newly founded “PMDA-ATC”, GMP department has raised three tasks such as 1) Contribution to the PIC/S activities, 2) Training to the Asian regulatory authorities, 3) Promote MRA conclusion.  I will present this specific activities and outcomes and future efforts including first event of the PIC/S committee meeting and seminar at Japan 2019.

2.
Since 2016, APAC started discussion on GMP area as one of common issues in Asia. To solve them, APAC members visited Singapore HSA to have suggestion and assistance of Mr. Boon, current PIC/S chairman. Actually initial discussion among stakeholders were rather confusing and tough, however, finally APAC’s effort achieved positive outcomes. The speaker will report the whole process.

3.
The Quality Committee, Japan Pharmaceutical Manufacturers Association (JPMA) is participating in APAC with the aim of improving access to innovative medicines to Asian countries from the viewpoint of quality and GMP. We will introduce the differences of the application of change application after acquiring approval and the contents of the recommendation obtained from the extraction of the problem point so far, making efficiency of GMP compatibility survey and confirmation process worked up to date in Asian countries.
 
Closed

Special Seminar

Venue: Keynote/Special Seminar Room K, East Hall 3
Capacity: 600 Seats Free of Charge ※Pre Registration required
March 18(Mon.)
K-2
11:00
|
12:00
Organoid Medicine for Pharmaceutical Applications
Dr. Takanori Takebe,
Professor, Institute of Research,
Professor, Advanced Medical Research Center,
 Associate Director, Center for Stem Cell and Organoid Medicine,
Assistant Professor, Division of Gastroenterology, Hepatology
and Nutrition and Division of Developmental Biology,
Tokyo Medical and Dental University,
Yokohama City University,
Cincinnati Children’s Hospital Medical Center

【Venue : Keynote/Special Seminar Room K, East Hall 3】

Organoids hold great promise to revolutionize 21st century healthcare through transforming drug development, precisionmedicine, and ultimately, transplantation-based therapies for end stage diseases, namely an “organoid medicine”. Here I will summarize the state of art of organoid medicine based strategies to shed light on an exciting based on iPSC-multi-cellular organoids.
Closed

K-4
14:00
|
15:00
Ms. Yasuko Aitoku
Dr. ​Toshihiko Kaise
Health Technology Assessment (HTA) and digital health
Ms. Yasuko Aitoku,
Access Committee, Chair of Access Committee, EFPIA Japan
Operating Officer, Head of Market Access, Bayer Yakuhin, Ltd.

Dr. Toshihiko Kaise
Access Committee, Vice Chair of Access Committee, EFPIA Japan
Healthoutcomes Dept., Japan Development Division, Department Manager, GlaxoSmithKline K.K.

【Venue : Keynote/Special Seminar Room K, East Hall 3】

Despite strong increases in total medical expenditures driven by an ageing population and the progress of medical technology, the current pricing system and measures such as greater generic use are proving sufficient to control drugs costs. However, this drastic pricing system reform in April 2018 brought devaluation for innovation. This reform would reverse the substantial progress already made, such as shrinking the “drug lag” and promotion of new drug development.

HTA evaluates health technology from multiple viewpoints. Advances in digital health have potential impacts on HTA. Application of medical big data to cost-effectiveness analysis and examination of disease burden can improve the quality and efficiency of the analysis/examination. Progress in precision medicine will require new methodology and processes of HTA which can appropriately evaluate technologies in precision medicine.
Closed

K-5
15:30
|
16:30
Be a Dream Come True: Creating In
-Body Hospitals by Nanotechnology
Prof. Kazunori Kataoka,
Innovation Center of NanoMedicine(iCOM), Kawasaki Institute of Industrial Promotion Director General,
KAWASAKI INSTITUTE OF INDUSTRIAL PROMOTION , Innovation Center of NanoMedicine(iCOM),
Professor,
Policy Alternative Research Institute, the University of Tokyo

【Venue : Keynote/Special Seminar Room K, East Hall 3】

We are developing the highly functionalized virus size (~50 nm) nanomachines based on the self-assembly of functional molecules (lego molecules), integrating the system necessary for treating or diagnosing diseases inside in our body. This concept may completely change the conventional ideas that patients are forced to be diagnosed and treated in hospitals. Here, I would like to present the progress of this “In-Body hospitals” project ongoing at Innovation Center of NanoMedicine (iCONM).
Closed

March 19(Tue.)
K-7
11:00
|
12:00
Simultaneous interpretation
Global Pharmaceutical industry, R&D And Clinical Trends
Mr. Ian Haydock,
Editor in Chief, Asia-Pacific,
Scrip/Pink sheet/In Vivo,
Informa Pharma Intelligence

【Venue : Keynote/Special Seminar Room K, East Hall 3】
【Language: English/ Japanese】
 
Closed

K-8
13:00
|
14:30
Simultaneous interpretation
API International Procurement Forum 2019 【Part 1】

Stable Supply and Quality Control of APIs for Generic Medicines with 80% Market Share
- luence of ICHQ3D Guideline on APIs and related Materials-


Organizer: Japan Pharmaceutical Traders’ Association

【Venue : Keynote/Special Seminar Room K, East Hall 3】
【Language: English/ Japanese】

API International Procurement Forum has been much appreciated as a customary event of CPhI Japan in the past by accumulating more than 600 of people each time who are active in the related industrial sectors. This year the Forum is going to discuss the current status of ICHQ3D presenting on European practices and Japanese situation inviting related industrial and regulatory people. Under the topic “Influence of ICHQ3D on API stable supply” , presentations from various industry and regulatory positions and a panel discussion will be given.

13:00-13:10  Greeting by Mr.Hideo Tsunoda, Chairman, JAPTA 
13:10-13:50  Lecture Mr.Kenichi Mikami, Office Director, Office of Reveiw Management
       Pharmaceuticals and Medical Devices Agency
                    "ICH Q3D Implementation and J.Phamacopoeia Revision" (Tentative title)
13:50-14:30  Lecture Ms. Marieke van Dalen, Chair, Japan Committee, APIC, CEFIC  

・How to prepare “Risk Assessment Data”, after obtaining analysis data by ICP-MS, ICP-OES, etc and smooth exchange of information between API manufacturers and finished drug manunfacturers ?

・How to respond when API manufacturers cannot provide analysis or risk assessment data?

・After deleting heavy metal testing from monographs and how to include analysis data by General Method into the Pharmacopeoia?

・How far the traders or importers should support the efforts?

・When would expansion of the scope be started in Japan?

・How should the change control be managed when the already approved drugs are included.
Closed

K-9
15:00
|
15:50
Simultaneous interpretation
Ono Pharmaceutical Challenge and Drug Discovery Innovation
Mr. Gyo Sagara,
Representative Director, and CEO,
ONO PHARMACEUTICAL CO., LTD.

【Venue : Keynote/Special Seminar Room K, East Hall 3】
【Language: English/ Japanese】

Ono Pharmaceutical is striving to discover and develop new drugs under its corporate philosophy of "Dedicated to Man’s Fight against Disease and Pain". We encountered lots of tough stages in the history of our 300 years in business foundation, but have overcome difficulties and created several innovations. In this seminar, we will present the history of Ono's challenge and the approach toward new drug discovery innovation.
Closed

K-10
16:10
|
18:35
Simultaneous interpretation
API International Procurement Forum 2019 【Part 2】

Stable Supply and Quality Control of APIs for Generic Medicines with 80% Market Share
- luence of ICHQ3D Guideline on APIs and related Materials-


Organizer: Japan Pharmaceutical Traders’ Association

【Venue : Keynote/Special Seminar Room K, East Hall 3】
【Language: English/ Japanese】

16:10-16:40  Lecture: ICH Q3D Current Implementation in Korea
       Dr. Kang Hyun Kyung,
       Deputy Director, Pharmaceutical Standardization Division ,
                      Drug Safety Evaluation, MFDS

16:40-17:10  Lecture: Recent API Imports without Heavy Metal Testing Data
                     Mr.Toshiyuki Harashima,
                     Assistant Manager, Pharmacist
                     Group Manager Healthcare Division Quality & Regulatory Unit, CBC Co., Ltd.
             Japan pharmaceutical trader’s Association (JPTA) 

17:10-18:30  Forum, a panel discussion on Q3D and International API Procurement

                    Panelists from
                    Ms.Chikako Yomota, Kobe Pharmaceutical University,
                    Mr.Kenichi Mikami, Office Director, Office of Reveiw Management Pharmaceuticals
                     and Medical Devices Agency (PMDA),
                    Ms.van Dalen, APIC,
                    Dr. Kang Hyun Kyung, Deputy Director Pharmaceutical Standardization Division,
                     
Drug Safety Evaluation, MFDS,
                   Mr. Tsunoda, Chairman, Japan Pharmaceutical Traders’ Association(JPTA)  
                   Mr. Fujikawa, Vice Chairman, Japan Pharmaceutical Traders’ Association(JPTA) 
                   Mr. Harashima, Japan Pharmaceutical Traders’ Association(JPTA) ,
                   Ms. Junko Ogasawara, Director, Drug Development analytical Research
                    Group, Analytical Research & Development Laboratories, 
                    Technology Research & Development Division, Sumitomo-Dainippon,
                     (JPMA) 
                   Mr. Norikazu Fujii, CH Japan RA Head, Regulatory Affairs,
                    GSK Consumer Healthcare Japan K.K.,(JSMI)

18:30-18:35  Closing remarks Mr. Ichiro Fujikawa, Vice Chairman, JAPTA


API International Procurement Forum has been much appreciated as a customary event of CPhI Japan in the past by accumulating more than 600 of people each time who are active in the related industrial sectors. This year the Forum is going to discuss the current status of ICHQ3D presenting on European practices and Japanese situation inviting related industrial and regulatory people. Under the topic “Influence of ICHQ3D on API stable supply” , presentations from various industry and regulatory positions and a panel discussion will be given.

・How to prepare “Risk Assessment Data”, after obtaining analysis data by ICP-MS, ICP-OES, etc and smooth exchange of information between API manufacturers and finished drug manunfacturers ?

・How to respond when API manufacturers cannot provide analysis or risk assessment data?

・After deleting heavy metal testing from monographs and how to include analysis data by General Method into the Pharmacopeoia?

・How far the traders or importers should support the efforts?

・When would expansion of the scope be started in Japan?

・How should the change control be managed when the already approved drugs are included.
Closed

March 20(Wed.)
K-13
13:00
|
14:00
Japanese Pharma’s global leadership: Is it competitive enough?
Mr. Atsushi Seki, R.Ph.
Global Research, Equities Research, Executive Research,
UBS AG

【Venue : Keynote/Special Seminar Room K, East Hall 3】

In the past 10 years, Japanese Pharma industry did not announce any meaningful consolidation. Takeda Pharma’s Shire acquisition is regarded as a story in a different world. Meanwhile, global pharmas obtained pipelines through internal development and acquisition, and boosted its profit and margin. What would be a turning point from status quo or moderate market share decline.
Closed

K-14
14:30
|
15:30
Simultaneous interpretation
Strategy on Biosimilars
Mr. Jason Hoffe,
Country Head Japan,
Sandoz K.K.

【Venue : Keynote/Special Seminar Room K, East Hall 3】
【Language: English/ Japanese】

Sandoz is committed to increasing patient access to high-quality biosimilar medicines. As the pioneer and global leader in biosimilar medicines, Sandoz has key biosimilar medicines currently marketed in various countries worldwide, as well as a leading global pipeline.  In Japan, Sandoz is well positioned to continue leading the biosimilar industry based on our experience and capabilities in development, manufacturing and commercialization globally. 
Closed

K-15
16:00
|
16:50
Future Medical Products Regulatory Policy of Japan
―Message to “Young” Japanese Regulators―
Mr. Shigeki Tsuda,
Senior Managing Director,
Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)

【Venue : Keynote/Special Seminar Room K, East Hall 3】

Last year, I talked about the Historical Turning Point of Medical Products Regulation.  This year, I’d like to give a message to “Young” Japanese Regulators on Future Medical Products Regulatory Policy of Japan, aiming one step forward.  While expectation to new Regenerative Medical Products is rising, it’s become difficult for companies to raise big profits in Japan.  This message is also useful to industry people.
Closed

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