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申込者情報の入力

Keynote/ Special Seminar

Keynote Seminer

Venue: Room 1A, West Hall 1
Capacity:: 400 Seats Free of Charge ※Pre Registration required
March 16(Mon.)
1A-1
9:15
|
10:30
Current topics regarding regulation of pharmaceuticals in Japan
Mr. Yoshida Yasunori,
Director, Pharmaceutical Evaluation Division,
Pharmaceutical Safety and Environmental Health Bureau,
Ministry of Health, Labour and Welfare (MHLW) 

*The Opening Ceremony will be held at the beginning of this seminar.
Closed

March 17(Tue.)
1A-5
10:30
|
11:30
Challenges Facing the Pharmaceutical Industry and the Direction for
Solutions
Mr. Osamu Nagayama,
Chairman, 
Chugai Pharmaceutical Co., Ltd.

Due to rising R&D costs and the debate on price issues in various countries, the business environment of the pharmaceutical industry is growing severe. In addition, there is an urgent need for pharmaceutical companies to apply new modalities such as biopharmaceuticals, mid-sized molecules, gene therapy and regenerative medicine. Some possible solutions for the industry will be introduced in the lecture.
Closed

March 18(Wed.)
1A-9
9:30
|
11:00

Closed

Special Seminar

Venue: Room 1A, West Hall 1
Capacity:: 400 Seats Free of Charge ※Pre Registration required
March 16(Mon.)
1A-2
11:00
|
12:00

Closed

1A-3
13:00
|
14:00
Realization of Regenerative Medicine by using iPS cells
Mr. Toru Kimura,
Member, Board of Directors, Senior Executive Officer,
Sumitomo Dainippon Pharma Co., Ltd.

Application of iPS cells for regenerative medicine is expected to provide innovative therapy to many uncured serious diseases. Sumitomo Dainippon Pharma has focused on the regenerative medicine to make a new business domain of the company. Recently a few programs are coming into clinical phase. An example of bringing basic science in a laboratory into human clinical phase will be introduced from a perspective of manufacture of cell products.
Closed

1A-4
15:00
|
16:00
Simultaneous interpretation
Mutagenic impurities and control strategy in the light of global
regulatory aspects
Mr. E Sreedhar,
Global Head of Regulatory Affairs, Regulatory Affairs, Dr. Reddy's Laboratories Ltd.

Language:English/Japanese

Since the sartan issue in 2018, pharma companies around the world have to pay close attention to the risk of potential genotoxic impurities in their drug products. In the light of the increasing regulatory requirements, which today requires the assessment of all drug products, this seminar includes a case study and covers the different aspects of a successful control strategy including: 
・Approaches to API development
・Defining an appropriate manufacturing process
・Selection of right KSMs
・Defining drug substance critical quality attributes, design space and life cycle management
Closed

March 17(Tue.)
1A-6
13:00
|
14:30
Simultaneous interpretation
Sponsored by Japan Pharmaceutical Traders’ Association
Beyond 2020-Change Control of APIs and International
Procurement (Part 1)

Language:Japanese/English】

Greetings by JPTA

Lectures
1.Change Control Process for finished drugs and APIs in EU
   Expected Speaker from APIC or EDQM
2.Change Control Process for finished drugs and APIs in China
   Expected Speaker from CCCMHPIE
3.Change Control Process for finished drugs and APIs in Korea
   Expected Speaker from KPTA/Korean authorities
Closed

1A-7
14:50
|
15:50
Simultaneous interpretation
The future of oncology
~A focused approach to winning in 2030~
Mr. Junichi Kurihara,
Partner, Head of Life Sciences, KPMG Japan

Language:Japanese/English】

Spiralling costs in research and development (R&D), shorter product lifecycles, fragmented patient markets and an increasing requirement to demonstrate value through a wider range of outcomes, are all limiting the potential return from expensive treatments. Incumbents failing to evolve in line with these trends are in danger of being outmaneuvered by novel entrants. In this Seminar, we assess how current business and operating models can be adapted to mitigate the effects of a changing oncology paradigm.
Closed

1A-8
16:15
|
18:00
Simultaneous interpretation
Sponsored by Japan Pharmaceutical Traders’ Association
Beyond 2020-Change Control of APIs and International
Procurement (Part 2)
APIC, CCCMHPIE, KPTA, JGA, JPMA, PMDA

Language:Japanese/English】

Lecture by PMDA
4) ICHQ12 Current Status and Change Control Process for finished drugs and APIs

Discussion by APIC, CCCMHPIE, KPTA, JGA, JPMA, PMDA

Topics for the lectures and discussion:
“What could be major problems of “change control” for drug manufacturers and API manufacturers?”

1. The advantages given by changes to drug manufacturers in accepting API

2. Necessity of defined classifications of proposed changes and their conditions

3. Time needed for approval process of proposed “partial change applications” and their transparency.

4. Cost of review and approval of proposed changes.

5. Is it possible to solve the current and possible disharmonizing of change control among the trilaterals without defined and agreed classifications of changes, depending only on the Q12 conditions?

6. For Japan, is it possible to solve the differences with the other partners of trilaterals, although the change control has been proposed by APIC for its harmonization last several years?

7. Regarding the change control the positions of API manufacturers and finished drug manufacturers are a little different; can Q12 guideline cover the differences?

Closing Remarks
Closed

March 18(Wed.)
1A-10
11:45
|
12:45
Simultaneous interpretation
Global R&D And Clinical Trends – What Changed In 2019, And What To Look Out For In 2020
Mr. Ian Haydock,
Editor in Chief, Asia-Pacific, Scrip/Pink sheet/In Vivo,
Informa Pharma Intelligence

Language:English/Japanese

•New drug launches 2019 – how does it compare to 2018?
•Which big pharma companies grew their pipelines and which pared theirs back
•What is the landscape of clinical candidates looking like?
•Biotech vs small molecules – is technology eclipsing old-school medicinal chemistry?
•Are there more novel targets for drugs across the industry, or are firms playing it safe?
•Will the rare disease boom continue?
Closed

1A-11
13:00
|
14:00

Closed

1A-12
15:00
|
16:00
How will the ICH E17 change multi-regional clinical trials?
Mr. Osamu Komiyama,
Senior Manager, Statistical Research & Data Science,
Pfizer R&D Japan

ICH E17 guideline, “General Principles for Planning and Design of Multi-Regional Clinical Trials (MRCT)”, may be difficult to understand for many people, but it offers various tips that may significantly change MRCT or global development. This presentation will explain E17 and consider what kind of changes could occur in future.
Closed

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