Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
Mr. Toshiro Nakagaki

The Fruits of emerging basic sciences such as genomics, proteomics and regenerative medicine should be quickly delivered to patients in Japan and the rest of the world while ensuring safety. For that purpose, we need to tackle issues like global simultaneous development/ approval, risk management through the lifecycle of pharmaceuticals, improvement of infrastructures for drug development including clinical trial facilities and the regulatory system, and ensuring quality of generic medicines.

Executive Officer & Executive General Manager, Manufacturing Division, Shionogi & Co., Ltd.
Dr. Ryuichi Kume

In the past ten years, the structure of pharmaceutical manufacturing and CMC (Chemistry, Manufacturing and Controls) study have been greatly changed by the change in environment of pharmaceutical industry including M&As of companies and reform of Japan Pharmaceutical Affairs Law. On the other hand, the importance of CMC studies and manufacturing technologies should be more and more enhanced to solve issues regarding the environmental change in drug discovery, maintenance and improvement of quality, improvement of productivity, succession of technologies, cost reduction, international harmonization, etc. Dr. Kume talks, based on his recognition that manufacturing is one of the core businesses in pharmaceutical industry, about the perspectives of CMC study and manufacturing, focusing on pharmaceutical companies in Japan.

President, Japan Generic Pharmaceutical Manufacturers Association* /
President, Sawai Pharmaceutical Co., Ltd.
Mr. Hiroyuki Sawai

Mankind owes largely the patent system for enjoying the grace of civilization. Although exclusive licenses are protected by the patent, after it expires, it becomes to public common property. This is the role of generics. In US and EU, 80% or more off-patent drugs are replaced by generics. Therefore 20 years behind western countries, the promotional measures of generics are at last going to be implemented in Japan, such as the re-modification of prescription forms and the incentives to the pharmacies. I would like to talk about these views.

Japan Representative, Pharmaceutical Research and Manufacturers of America
Mr. Ira Wolf

With the fastest aging society in the world and a mature economy that many predict will grow in the range of two percent or less over the coming years, how to provide healthcare for its aging population and how to maintain a productive aging workforce are major challenges for Japan. Innovative pharmaceuticals provide one of the answers. This presentation will look at the changing pharmaceutical environment in Japan as the government begins to address these challenges.

Japan Technical Representative, Pharmaceutical Research and Manufacturers of America
Toshihiko Kobayashi Ph.D.

The major pharmaceutical firms in Japan, the U.S. and Europe have for long been focusing their strategies on the U.S. in view of the wealth of human resources, the active public-private sector coordination and the size of the healthcare budget (to the tune of 150 trillion yen) in that country. At the same time, the background to R & D investment in Japan by the U.S. and European pharmaceutical giants covering the period from the 1980s boom in the construction of Japanese research laboratories through to Japan's current withdrawal from drug discovery (the closure of research laboratories) shall be examined and ways to revive this investment studied - this shall be the perspective of this presentation.

Vice Secretary-General REACH Task Force, Japan Chemical Industry Association
Fumiaki Shono Ph.D.

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) entered into force on June 1 last year taking the place of EU direction (67 / 548 / EEC), and will be formally implemented substantially on June 1, 2008. In this session we will introduce the regulatory outline of REACH and also try to clarify the substances that are exempted from the parts of REACH provision, where other equivalent legislation applies such as human or veterinary use products, food feeding stuffs etc. Further, with designating some remaining issue or problems to be solved on REACH, JCIA's current activity and the challenges will be introduced briefly.

Mr. Tim Jessel, Commercial Director, REACHReady

ICH-Q10 Deputy Topic Leader, The Japan Pharmaceutical Manufacturers Association Director, Quality Assurance Department, Pharmaceuticals, Meiji Seika Kaisha, Ltd.
Mr. Makoto Shigemitisu

The ICH Steering Committee adopted for consultation last year, "Pharmaceutical Quality Systems" (ICH-Q10 guideline) which will complement existing GMPs, having been required as a requisite and standardized manufacturing and quality controls, with modern quality systems elements, such as CAPA and management review. The progress of working group activities for ICH-Q10 will be reviewed, and differences with GMP and current needs of the Japanese pharmaceutical and related industries to facilitate continual improvement will be discussed.

Former Member of Quality & Technology Standing Committee, The Federation of Pharmaceutical Manufacturer's Associations of Japan
Mr. Masahiro Minoya

It has been possible to contract out the manufacturing of drug substances since the enforcement of the amended Pharmaceutical Affairs Law. This paper introduces the relationship between licensed marketing approval holders and manufacturers of drug substances, from the standpoint of a licensed marketing approval holder, in terms of the following items: appointment of a manufacturer in contracting out the manufacturing of drug substances; technology required to make up the quality of drug substances during the manufacturing process; how to send the information for technology transfer; administrative procedures by licensed marketing approval holders associated with drug manufacturing contracts.

Vice-chairman of GMP committee, Japan Bulk Pharmaceutical Manufacturers Association General Manager, Quality Assurance Dept. (Kashima), Advanced Materials Business Div., Tokuyama Corporation
Mr. Takao Tsunematsu

This session will examine how makers of active pharmaceutical ingredients need to approach the issue of product quality assurance as encapsulated by GMP when addressing the quality control of the ingredients that they manufacture for use in end-use pharmaceutical products. The session will also discuss the way in which API makers need to cooperate with pharmaceutical manufacturers in the new era of outsourced manufacturing that has been enabled by the enactment of the revised Pharmaceutical Affairs Law. The session will use case studies as illustrations.

Director, Economic Affairs Division, Health Policy Bureau, Ministry of Health, Labour and Welfare
Mr. Toshihiko Takeda

The Japanese Government set a target of promoting the usage of generic drugs last year. The target is that the drug prescription share should be 30% or more, almost double from current 16.9%, in 5 years. In order to achieve this goal, the Japanese Government announced that it will carry out a new action program for securing the quality and supply of generic drugs. It is also decided that, in the Japanese national health insurance system, the drug prescription formula to be changed and financial incentives to be given to pharmacies.

Associate Executive Director, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
Mr. Takahisa Murakami

Consumers have high expectations for the development of safer and more-effective pharmaceuticals and have a deep interest in their progress. The Pharmaceuticals and Medical Devices Agency, which is responsible for the examination of new pharmaceuticals and medical devices for possible introduction into the domestic market, therefore wears a heavy mantle of responsibility. Pharmaceutical companies are requiring transparency in the PMDA's examination process and an easier system for consultation with the agency. I will give a general overview of the agency's current challenges and outline the activities envisioned for its future.

SOCMA and REACHReady will address on the chemical substance management in USA and EU．

1.Chemical substance controls in USA and its management activities of SOCMA
Mr. Joseph Acker, President of SOCMA

Mr. Acker will address on the latest situations on chemical substance controls in USA (TSCA, US HPV, SPP etc.) and SOCMA's ChemStewards program which is the only EHS&S program designed specifically for the unique requirements of the batch, custom and specialty chemical industry.

2. REACH In-depth – key issues for Japanese companies
Mr. Tim Jessel, Commercial Director, REACHReady

*Please note the speaker has been changed.

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