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1 7 th DIA Japan Annual Meeting Japan s Role and Contribution to Global Development October 28-29, 2010 Tower Hall Funabori, Tokyo, Japan PROGRAM CHAIR MASARU IWASAKI, MD, PhD PROGRAM VICE-CHAIR JUNKO SATO, PhD Pharmaceuticals and Medical Devices Agency (PMDA), Japan PROGRAM COMMITTEE YUKI ANDO Pharmaceuticals and Medical Devices Agency (PMDA), Japan KEIKO EBIHARA MSD K.K., Japan E. STEWART GEARY, MD Eisai Co., Ltd., Japan HIROKO KOYAMA, RPh Pharmaceutical and Medical Device Regulatory Science Society of Japan YUJI KUMAGAI, MD, PhD Kitasato University East Hospital, Japan MASAAKI KUWAHARA, PhD Takeda Pharmaceutical Company Limited, Japan NORIAKI MURAO Merz Pharmaceuticals GmbH, Japan HIDEFUMI NAKAMURA, MD, PhD National Center for Child Health and Development, Japan MAKOTO ONO YOSHIHIKO ONO Pfizer Japan Inc., Japan HIRONOBU SAITO, PhD Daiichi Sankyo Co., Ltd., Japan ERI SEKINE Novartis Pharma K.K., Japan HIDETOSHI SHUTO, MS Astellas Pharma Inc., Japan KIHITO TAKAHASHI, MD, PhD LOTUS Pharmaceutical Co., Ltd., The Japanese Association of Pharmaceutical Medicine, Japan NAOKI UCHIDA, MD, PhD Showa University, Japan YOSHIAKI UYAMA, PhD Pharmaceuticals and Medical Devices Agency (PMDA), Japan TOSHIKAZU YOSHINAGA PROGRAM ADVISOR KAZUHIKO MORI Pharmaceuticals and Medical Devices Agency (PMDA), Japan KYOICHI TADANO, PhD Pharmaceuticals and Medical Devices Agency (PMDA), Japan PROGRAM COORDINATOR MINORU KUDO Torii Pharmaceutical Co., Ltd., Japan CONFERENCE OVERVIEW At a time when globalization of pharmaceutical development is moving extremely quickly, it is important to create an opportunity to consider what direction should be taken in Japan and Asia and where we should look to the future through the clarification of Japan s role and contribution in global development. As keynote speakers, Dr. Fumimaro Takaku, President, Jichi Medical University and President, The Japanese Association of Medical Sciences, and Dr. Yasuo Ikeda, Professor, Life Science and Medical Bioscience, Faculty of Science and Engineering, Waseda University, both leading Japanese medical authorities, will present on How to Nurture and Develop Products of Japanese Origin and Japan s Capability in Global Development respectively. In addition, Dr. Murray Lumpkin, FDA Deputy Commissioner for International and Special Programs, Dr. Thomas Lönngren, Executive Director of the European Medicines Agency, and Dr. Tatsuya Kondo, Chief Executive of the PMDA will have a discussion chaired by Professor Tatsuo Kurokawa, Graduate School of Pharmaceutical Sciences, Chiba University on Expectations for the Role of Asia and Japan in Global Development. Another session is planned to discuss wide-ranging topics among those working in regulatory authorities and within pharmaceutical development in industry. CONFERENCE THEMES Session topics during the two day workshop are as follows: Proof-of-concept and Dose-finding Studies in Global Development Pediatric Medicines Experience from the Pandemic Crisis Adaptive Design in Japan Quality Improvement; Lean Six Sigma Therapeutic Risk Management and Postmarketing Surveillance Clinical Research This conference aims to contribute to the further advancement of international clinical development by deepening the mutual under standing among those working in the pharmaceutical industry, academia and regulatory authorities. Tabletop Exhibit Opportunity For information contact Drug Information Association, LLC Maruei Building 4F, Iwamoto-cho, Chiyoda-ku, Tokyo Japan Tel: Fax: [email protected] Endorsement by MHLW, PMDA, and JPMA. Simultaneous Translation Available Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China

2 2 DAY 1 THURSDAY, OCTOBER 28, :00 10:30 REGISTRATION 2nd Floor Lobby 10:30 11:00 WELCOME AND OPENING REMARKS Large Hall (5F) Paul Pomerantz, MBA Worldwide Executive Director, DIA Tatsuo Kurokawa, PhD Chair, DIA Advisory Council of Japan Professor, International Clinical Development and Regulatory Sciences, Graduate School of Pharmaceutical Sciences, Chiba University, Japan Masaru Iwasaki, MD, PhD Vice President, Development and Medical Affairs Division, 2010 AWARDS PRESENTATION 11:00 12:20 KEYNOTE SESSION Large Hall (5F) Masaru Iwasaki, MD, PhD Vice President, Development and Medical Affairs Division, Junko Sato, PhD Director for Risk Management, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 11:00 11:40 KEYNOTE 1 How to Nurture and Develop Products of Japanese Origin Fumimaro Takaku, MD, PhD President, Jichi Medical University, Japan and President, The Japanese Association of Medical Sciences 11:40 12:20 KEYNOTE 2 Japan s Capability in Global Development Yasuo Ikeda, MD, PhD Professor, Life Science and Medical Bioscience, Faculty of Science and Engineering, Waseda University, Japan 12:20 13:20 LUNCH BREAK Free lunch is available in Zuiun (2F) 13:20 14:50 PARALLEL TRACKS SESSION 1 Presentation Title to Be Confirmed TRACK A Large Hall (5F) Dominic G. Spinella Executive Meaning Director, of Global Translational Clinical and Molecular Trials Medicine, Bio Therapeutics Research, Pfizer Global at an Early Stage and a Matter for Research and Development, XXXXX Consideration Part 1 Importance of the Involvement of Academia in Preliminary Global Clinical Trials Noriaki Murao Masahiro Takeuchi, ScD Representative, Japan Representative Office, Professor of Biostatistics and Pharmaceutical Merz Pharmaceuticals GmbH, Japan Medicine, Department of Clinical Medicine, Kitasato University Yoshiaki School Uyama, of Pharmacy, PhD Japan Review Director, Office of New Drug III, Efforts Pharmaceuticals of a Japanese and Medical Pharmaceutical Devices Agency Company (PMDA), to Conduct Japan Global Clinical Trials from Early Phase TRACK B Fukuju (2F) Providing Meaningful Safety Information Part 1 E. Stewart Geary, MD Vice President, Deputy Director, Corporate Regulatory Compliance and Quality Assurance Headquarters, Eisai Co., Ltd., Japan Hiroko Koyama, RPh Counselor, Training and Planning Coordinator, Pharmaceutical and Medical Device Regulatory Science Society of Japan TRACK C Togen (2F) Taking a Lesson from the Pandemic Crisis in Japan Part 1 Makoto Ono Associate Department Manager, Stiefel, Phase IV and Local Development, Development and Medi cal Affairs Division, Junko Sato, PhD Director for Risk Management, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 13:20-13:50 A Personal View of Personalized Medicine Dominic G. Spinella, PhD Executive Director, Translational and Molecular Medicine, Bio Therapeutics Research, Pfizer Global Research and Development, USA 13:50-14:20 Importance of the Involvement of Academia in Preliminary Global Clinical Trials Masahiro Takeuchi, ScD, MPH Professor of Biostatistics and Pharmaceutical Medicine, Department of Clinical Medicine, Kitasato University School of Pharmacy, Japan 14:20-14:50 Efforts of a Japanese Pharmaceutical Company to Conduct Global Clinical Trials from Early Phase Koichi Miyazaki, MSc Manager, Clinical Development Group, Asia Development Department, Daiichi Sankyo Co., Ltd., Japan 13:20-13:50 What Safety Information is Desired by Clinical Practitioners Masakatsu Nishikawa, MD, PhD Director, Clinical Research Support Center, Mie University Hospital, Japan 13:50-14:20 What Is Desired in Safety Information from Medical Practice Masahiro Hayashi, PhD Director, Department of Pharmacy, Toranomon Hospital, Japan 14:20-14:50 What Regulators Desire in Safety Information Mie Ikeda Director, Office of Safety I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 13:20-13:50 Point of View from a Japanese Pharmaceutical Company Yoichiro Kino, MSc, DMSc General Manager, Second Research Department, The Chemo-Sero Therapeutic Research Institute, Kaketsuken, Japan 13:50-14:20 Point of View from a Foreign Pharmaceu tical Company Yasuyuki Uechi, MD Deputy Director, Development and Medical Affairs Division, 14:20-14:50 Point of View from a Hospital Hideaki Nagai, MD, PhD Head of Ambulatory Care, Department of Respiratory Diseases, National Hospital Organization, Tokyo National Hospital, Japan

3 3 DAY 1 THURSDAY, OCTOBER 28, 2010 continued 14:50 15:20 COFFEE BREAK Zuiun (2F) 15:20 17:20 PARALLEL TRACKS SESSION 2 Presentation Title to Be Confirmed TRACK A Large Hall (5F) Dominic G. Spinella Executive Meaning Director, of Global Translational Clinical and Molecular Trials Medicine, Bio Therapeutics Research, Pfizer Global at an Early Stage and a Matter for Research and Development, XXXXX Consideration Part 2 Importance of the Involvement of Academia in Preliminary Global Clinical Trials Yoshihiko Ono Masahiro Takeuchi, ScD Director, Regulatory Policy and Intelligence, Professor of Biostatistics and Pharmaceutical Pfizer Japan Inc., Japan Medicine, Department of Clinical Medicine, Kitasato University Hironobu School Saito, of Pharmacy, PhD Japan Director, Group II, New Drug Regulatory Efforts Affairs of Department, a Japanese Daiichi Pharmaceutical Sankyo Co., Company Japan to Conduct Global Clinical Trials from Ltd., Early Phase TRACK B Fukuju (2F) Providing Meaningful Safety Information Part 2 Tatsuo Kagimura, MPH Senior Statistician, Biostatistic Group, Medical Data Services Department, Nippon Boehringer Ingelheim Co., Ltd., Japan Akiyoshi Uchiyama, MD, PhD President, Artage Inc., Japan TRACK C Togen (2F) Taking a Lesson from the Pandemic Crisis in Japan Part 2 Makoto Ono Associate Department Manager, Stiefel, Phase IV and Local Development, Development and Medi cal Affairs Division, Junko Sato, PhD Director for Risk Management, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 15:20-15:50 Importance of Japanese Data in the Early Stage of Global Clinical Trials on the Evaluation of Ethnicity-related Drug Response Factors from a Regulatory Perspective Yoshiaki Uyama, PhD Review Director, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 15:50-16:20 A European Viewpoint on the Evaluation of Ethnicity-related Drug Response Factors for an Acceptance of Foreign Clinical Data for Marketing Authorization Kristina Dunder, MD, PhD Clinical Assessor, Medical Products Agency, Sweden 16:20-17:20 Panel Discussion All speakers from Sessions 1 & 2 15:20-15:50 Actual Use of Safety Databases K. Arnold Chan, MD, ScD, FISPE Chief Scientist, i3 Drug Safety, USA 15:50-16:15 Maximizing Clinical Value with Safety Information: From Development to Postmarketing by Industry Tomomi Kimura, MD, PhD Senior Epidemiologist, Biostatistics and Research Decision Sciences, Clinical Development Institute, MSD K.K., Japan 16:15-16:40 Signals, Databases, and Pharmacoepidemiologic Studies Tosiya Sato, PhD Professor, Department of Biostatistics, Kyoto University School of Public Health, Japan 16:40-17:20 Panel Discussion All speakers from Sessions 1 & 2 15:20-16:00 Influenza A/H1N Outbreak in Japan Nobuhiko Okabe, MD, PhD Director, Infectious Disease Surveillance Center, National Institute of Infectious Disease, Japan 16:00-16:30 Regulatory Point of View Mayumi Shikano, PhD Director, Office of Biologics II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 16:30-17:20 Panel Discussion All speakers from Session 1 and Mayumi Shikano, PhD Director, Office of Biologics II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 17:45 19:30 RECEPTION Zuiun (2F)

4 4 DAY 2 FRIDAY, OCTOBER 29, :30 9:00 REGISTRATION 2nd Floor Lobby 9:00 10:30 PARALLEL TRACKS SESSION 3 Presentation Title to Be Confirmed TRACK A Large Hall (5F) Dominic G. Spinella Executive Pediatric Director, Drug Translational Development and Molecular in the Medicine, Bio Therapeutics Research, Pfizer Global Global Context Part 1 Research and Development, XXXXX Importance of the Involvement of Academia Masaaki Kuwahara, PhD in Preliminary Global Clinical Trials Senior Director, Regulatory Affairs Masahiro Department, Takeuchi, Japan ScD Development Center, Professor Pharmaceutical of Biostatistics Development and Pharmaceutical Division, Medicine, Takeda Pharmaceutical Department of Clinical Company Medicine, Limited, Kitasato University Japan School of Pharmacy, Japan Efforts Hidefumi of a Japanese Nakamura, Pharmaceutical MD, PhD Company Division to Conduct Chief, Division Global for Clinical Trials, from Early Clinical Phase Research Center, National Center for Child Health and Development, Japan TRACK B Fukuju (2F) Current Situation and Challenges in Clinical Research from an Academic and Industry Point of View Part 1 Yuji Kumagai, MD, PhD Director, Clinical Trial Center, Kitasato University East Hospital, Japan Kihito Takahashi, MD, PhD President and CEO, Lotus Pharmaceutical Co., Ltd.; Councilor, The Japanese Association of Pharmaceutical Medicine, Japan TRACK C Togen (2F) Adaptive Design Study for CRA: Operational Challenges at GENBA of Adaptive Design Study Hideki Suganami, PhD, CJBS Manager, Statistical Analysis Section, Biostatistics and Data Management Department, Pharmaceutical Development Department, Pharmaceutical Division, Kowa Company Ltd., Japan Eri Sekine Head of Oncology Biometrics and DM Department, Oncology Development, Oncology B.U., Novartis Pharma K.K., Japan 9:00-9:25 A Decade Later: Why Product Development for Children Is Global Dianne Murphy, MD, FAAP Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA, USA 9:25-9:50 Implementing Pediatric Legislation in Europe Three Years Later Agnès Saint Raymond, MD Human Medicines Development and Evaluation, European Medicines Agency, European Union 9:50-10:10 Regulatory Perspective in Japan Haruo Akagawa Associate Center Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 10:10-10:30 Industry Perspective in Japan Nobuhiro Noro, PhD Head, Vaccine Clinical Development, Development and Medical Affairs Division, 9:00-9:20 Clinical Research on Cancer Peptide Therapy at National Cancer Center Hospital East Tetsuya Nakatsura Section Head, Section for Cancer Immunotherapy, National Cancer Center Hospital East, Japan 9:20-9:40 Training Investigators to Conduct Clinical Research: A Global Perspective David S. Miller, MD, MA Practice Leader, Specialty Clinical Services, United BioSource Corporation, USA 9:40-10:00 Creating Support Systems for Clinical Studies in Academic Medical Institutes Yuji Kumagai, MD, PhD Director, Clinical Trial Center, Kitasato University East Hospital, Japan 10:00-10:20 Issues in Supporting Clinical Research from Industry Kyoko Imamura, DrMed, MD, PhD, Sci Scientific Relations Officer, Janssen Pharmaceutical K.K., Japan and Chairperson of The Japanese Association of Pharmaceutical Medicine, Japan 9:00-9:10 Session Overview Hideki Suganami, PhD, CJBS Manager, Statistical Analysis Section, Biostatistics and Data Management Department, Pharmaceutical Development Department, Pharmaceutical Division, Kowa Company Ltd., Japan 9:10-9:30 Operational Efforts in Our First Challenge of Adaptive Design Study Atsushi Utsuno Senior Director, Clinical Development II, Development, Astellas Pharma Inc., Japan 9:30-9:50 What Is Happening in Operation of Adaptive Design Studies? Yumiko Suzuki, PhD Associate Director, Clinical Trial Team Leader, Clinical Study Management, Development Operations, Pfizer Japan Inc., Japan 9:50-10:30 Panel Discussion All speakers from Session 3 and Yuki Ando Principal Reviewer for Biostatistics, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 10:30 11:00 COFFEE BREAK Zuiun (2F)

5 5 DAY 2 FRIDAY, OCTOBER 29, 2010 continued 11:00 12:30 PARALLEL TRACKS SESSION 4 Presentation Title to Be Confirmed 11:00-11:30 TRACK A Large Hall (5F) TRACK B Fukuju (2F) Dominic G. Spinella 11:00-11:30 Executive Pediatric Director, Drug Translational Development and Molecular in the Current Situation and Challenges Medicine, Bio Therapeutics Research, Pfizer Global Global Context Part 2 in Clinical Research from an Research and Development, XXXXX Academic and Industry Point Importance of the Involvement of Academia Masaaki Kuwahara, PhD of View Part 2 in Preliminary Global Clinical Trials Senior Director, Regulatory Affairs Masahiro Department, Takeuchi, Japan ScD Development Center, Professor Pharmaceutical of Biostatistics Development and Pharmaceutical Yuji Kumagai, MD, PhD Division, Medicine, Takeda Pharmaceutical Department of Clinical Company Medicine, Limited, Kitasato Director, Clinical Trial Center, Kitasato University Japan School of Pharmacy, Japan University East Hospital, Japan Efforts Hidefumi of a Japanese Nakamura, Pharmaceutical MD, PhD Company Division to Conduct Chief, Division Global for Clinical Trials, from Kihito Takahashi, MD, PhD President and CEO, Lotus Pharmaceutical Co., Ltd.; Councilor, The Japanese Association Early Clinical Phase Research Center, National Center for of Pharmaceutical Medicine, Japan Child Health and Development, Japan TRACK C Togen (2F) Continual Process Improvement in Research & Development: Application of Lean Six Sigma to Research & Development Osamu Komiyama Senior Manager, Statistical Research and Consulting Group, Clinical Statistics, Pfizer Japan Inc., Japan Hiroe Tsubaki, PhD Vice Director-General of the Institute of Statistical Mathematics, Director of Risk Analysis Research Center, and Professor of Department of Data Science, Japan 11:00-11:30 The Present and the Future of Pediatric Clinical Trials: Investigators Perspective Hidefumi Nakamura, MD, PhD Division Chief, Division of Clinical Trials, Clinical Research Center, National Center for Child Health and Development, Japan 11:30-12:30 Panel Discussion All speakers from Sessions 3 & 4 11:00-11:20 Current Situation and Challenges in the Development of Physician Investigators in Japan Shinichi Kobayashi, MD, PhD Professor, Department of Pharmacology, St. Marianna University School of Medicine, Japan 11:20-11:40 Japan s Policies for Clinical Research Takeyuki Sato Director, Office of Clinical Trial Promotion, Research and Development Division, Ministry of Health, Labour and Welfare (MHLW), Japan 11:40-12:00 Clinical Research in Korea In-Jin Jang, MD, PhD Professor, Department of Pharmacology, Clinical Pharmacology and Clinical Trials Center, Seoul National University College of Medicine & Hospital, Republic of Korea 12:00-12:30 Panel Discussion All speakers from Sessions 3 & 4 11:00-11:40 Total Quality Management vs. Lean Six Sigma Fundamental Principle, Renamed Tool and Management Fad Shu Yamada, DrEng Professor of Quality Management, Graduate School of Business Sciences, University of Tsukuba, Japan 11:40-12:00 Process Improvement in Drug Discovery: A Holistic Approach Using Quality Management Tools Hirotaka Inoue, PhD, MBA Project Management Department, Development and Medical Affairs Division, GlaxoSmithKline K.K., Japan 12:00-12:20 Improvement of Clinical Development by Six Sigma Methodology Hitoshi Imazato, MS Manager/Blackbelt, Six Sigma, Eli Lilly Japan K.K., Japan 12:20-12:30 Session Summary by Chairs 12:30 13:30 LUNCH BREAK Free lunch is available in Zuiun (2F)

6 6 13:30 15:00 ROUNDTABLE DISCUSSION Large Hall (5F) Expanding Japan s Presence in Global Drug Development Masaru Iwasaki, MD, PhD Vice President, Development and Medical Affairs Division, Junko Sato, PhD Director for Risk Management, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Panelists: Masaaki Kuwahara, PhD Senior Director, Regulatory Affairs Department, Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited, Japan Shunsuke Ono, PhD Associate Professor, Laboratory of Pharmaceutical Science, The University of Tokyo, Japan Yoshiaki Uyama, PhD Review Director, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Toshikazu Yoshinaga Manager, Regulatory Affairs Department 2, Development and Medical Affairs Division, 15:30 17:30 REGULATORY SPECIAL SESSION Large Hall (5F) Expectations for the Role of Asia and Japan in Global Development SESSION CHAIRPERSON Tatsuo Kurokawa, PhD Chair, DIA Advisory Council of Japan Professor, International Clinical Development and Regulatory Sciences, Graduate School of Pharmaceutical Sciences, Chiba University, Japan Panelists: Tatsuya Kondo, MD, PhD Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Thomas Lönngren, PharmD, MPharm, MSc Executive Director, European Medicines Agency, European Union Murray M. Lumpkin, MD, MSc Deputy Commissioner for International Programs, FDA, USA 17:30 17:45 CLOSING REMARKS Masaru Iwasaki, MD, PhD Vice President, Development and Medical Affairs Division, 15:00 15:30 COFFEE BREAK Zuiun (2F) 17:45 MEETING ADJOURNED UPCOMING EVENTS IN 2011 January 27-28, 2011 Tower Hall Funabori, Tokyo, Japan 14th Annual Workshop in Japan for Clinical Data Management New Genesis of CDM to Drive Worldwide Clinical Studies 3D Age: Data, Diversity, Direction Program Chair: Atsushi Tsujii, UCB Japan Co., Ltd., Japan May 10-11, 2011 Tower Hall Funabori, Tokyo, Japan 5th Annual Conference in Japan for Asian New Drug Development Program Chair: Hironobu Saito, PhD, Daiichi Sankyo Co., Ltd., Japan October 27-28, 2011 Tower Hall Funabori, Tokyo, Japan 8th DIA Japan Annual Meeting Beginning in June, 2011 Tokyo, Japan 4th DIA Regulatory Affairs Training Course (10 sessions) Program Chair: Keiko Ebihara, MSD K.K., Japan March 28-30, 2011 Geneva, Switzerland 23rd Annual EuroMeeting June 19-23, 2011 Chicago, USA 47th Annual Meeting

7 7 General Information Registration Registration will start at 9:00 on the first day, and at 8:30 on the second day, on the 2nd floor. Exhibition Thursday, October 28, 12:20 19:30 in the room ZUIUN on the 2nd floor. Friday, October 29, 9:00 17:45 in the room ZUIUN on the 2nd floor. Reception Thursday, October 28, 17:45 19:30 in the Exhibition Hall on the 2nd floor (Zuiun). Hotel: There are a limited number of rooms at the Hotel Grand Palace at the reduced rates shown below. To reserve a room at the reduced rates for DIA, attendees must use the Hotel Reservation Request Form from the Hotel Grand Palace. Private Social Function Policy DIA does not allow hospitality functions to be held during any DIA meeting sessions, scheduled exhibit hours, or social events. Therefore, the hours noted below are the only hours that are acceptable for hospitality functions. Wednesday, October 27 All times are acceptable Thursday, October 28 7:00 10:00 am and after 8:00 pm Friday, October 29 7:00 8:45 am and after 6:00 pm To download this form, go to Hotel_Reservation_Form.pdf or CLICK HERE. Room Rates Single 18,050/night / Twin 21,525/night Address: Iidabashi, Chiyoda-ku, Tokyo Japan Telephone: +81-(0) Fax: +81-(0) [email protected] URL: Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA. Contact and Exhibit Information For meeting and tabletop exhibit information, contact Keiko Cambridge at the Drug Information Association, LLC office in Tokyo by: Telephone: Fax: [email protected] If you are interested in obtaining space for a tabletop exhibit, please check the box in the REGISTRATION FEE area on page 8.

8 REGISTRATION FORM: Register online or forward to Drug Information Association, LLC (Japan) Office, Maruei Building 4F, Iwamoto-cho, Chiyoda-ku, Tokyo Japan tel fax th DIA Japan Annual Meeting: Japan s Role and Contribution to Global Development Event #10303 October 28-29, 2010 Tower Hall Funabori, Tokyo, Japan DIA will send participants a confirmation letter within 3 to 5 business days after receipt of their registration. Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks and reception (if applicable), and will be accepted by mail, fax, or online. All fees listed below include the 5% consumption tax. Member Early-bird Opportunity On or before After Available on nondiscount member fee only. OCTOBER 1, 2010 OCTOBER 1, 2010 Member Fee 61,950 67,200 Join DIA now to save on future meetings and to enjoy the benefits of membership for a full year! Nonmember Fee 82,950 MEMBERSHIP 15,750 A one-year membership to DIA is available to those paying a NONMEMBER registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. I DO want to be a DIA member I DO NOT want to be a DIA member Discount Fees MEMBER NONMEMBER Government (Full-time) 26,250 42,000 Charitable Nonprofit/Academia (Full-time) 26,250 42,000 *If paying a nonmember fee, please check one box above, indicating whether you want membership. TRAVEL AND HOTEL There are a limited number of rooms at the Hotel Grand Palace at the reduced rates shown below. Room availability at this rate is guaranteed only until SEPTEMBER 27, 2010 or until the room block is filled. Attendees should make their airline and room reservations as soon as possible. Single 18,050/night / Twin 21,525/night Address: Iidabashi, Chiyoda-ku, Tokyo , Japan Telephone: +81-(0) / Fax: +81-(0) [email protected] URL: To reserve your room, please contact the Hotel Grand Palace above and mention the DIA Workshop or click here for the Hotel Reservation Form. CANCELLATION POLICY: On or before OCTOBER 21, 2010 Administrative fee that will be withheld from refund amount: Member or Nonmember = 21,400 Government/Academia/Nonprofit (Member or Nonmember) = 10,700 Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. TO RECEIVE AN EXHIBIT APPLICATION, PLEASE CHECK Please check the applicable category: Academia Government Industry CSO (Contract research/service organization) Student (Call for registration information) TABLETOP EXHIBIT INFORMATION Attendees may visit the tabletop exhibits during the event and receptions. Contact the Drug Information Association, LLC office in Tokyo. Telephone +81-(0) Fax +81-(0) [email protected] If you are interested in obtaining space for an exhibit, please check the box in the REGISTRATION FEE area on the left. Last Name First Name M.I. PAYMENT OPTIONS: Register online at or check payment method. Degrees Dr. Mr. Ms. Job Title Company Address (As required for postal delivery to your location) City State Zip/Postal Country BANK TRANSFER TO: CITIBANK, N.A. Akasaka Branch, Prudential Plaza, Nagatacho , Chiyoda-ku, Tokyo , Japan Drug Information Association Ordinary Account Number: , SWIFT CODE # CITIJPJT. Your name and company, as well as the above event I.D. number, must be included on the transfer document to ensure payment to your account. All local and overseas charges incurred for the bank transfer must be borne by payer. Please include BANK TRANSFER REFERENCE # Required for confirmation PAYMENT BY CREDIT CARD is available online only Phone Number Required Fax Number

9 第7回 DIA日本年会 グローバル開発における 日本の役割 日本の貢献 2010年10月28日(木) 29日(金) タワーホール船堀 東京都江戸川区船堀4-1-1 プログラム委員長 グラクソ スミスクライン株式会社 岩﨑 甫 プログラム副委員長 独立行政法人 佐藤 医薬品医療機器総合機構 淳子 プログラム委員 独立行政法人 安藤 医薬品医療機器総合機構 友紀 MSD株式会社 海老原 恵子 エーザイ株式会社 ステュワート 財団法人 小山 ギリー 日本公定書協会 弘子 北里大学東病院 熊谷 雄治 武田薬品工業株式会社 桑原 雅明 メルツ ファーマシューティカルズ 村尾 典昭 独立行政法人 中村 秀文 国立成育医療研究センター グラクソ スミスクライン株式会社 小野 真 ファイザー株式会社 小野 嘉彦 第一三共株式会社 齋藤 宏暢 ノバルティス ファーマ株式会社 関根 恵理 概要 医薬品開発は各地域で開発を行うのではなく グローバルの視点か らの戦略に従って開発することが主流になっています この流れに 対して これまで日本ではどのように行動してきたかの経験を振り 返り そこから日本が世界的な医薬品開発において今後どのような 役割を果たすべきか どのような貢献をすべきかを検討する機会と したいと考えています このため 医学界の重鎮である 自治医科大学学長 日本医学会会長 髙久史麿先生ならびに早稲田大学理工学術院生命医科学科教授 池田康夫先生に それぞれ 日本オリジンをどう育てるか どう開 発していくか および グローバル開発における日本のCapability という題で基調講演をお願いしました また 千葉大学大学院薬学 研究院特任教授 黒川達夫先生を座長に迎え 国際共同開発における アジアの位置付けと日本への期待 というテーマでの対談を 日米 欧の規制当局の責任者であるFDA副長官 Dr. Lumpkin EMA長官 Dr. Lönngren およびPMDA 近藤達也理事長の三者で行います さらに 本テーマに関して企業と行政の間の自由な討議も行います また 多くの医薬品で小児適応の取得がなかなか進まない現状をど うやって改善していくべきかとの討議や 日本の開発戦略のなかに Adaptive Designを如何に適応していくべきか さらに 開発から 市販後まで幅広い安全性情報の情報管理や EBMを視野に入れた 市販後臨床研究についても検討を行います 参加者の皆さまの積極 的な討議への参加を期待しています テーマ 国際開発におけるPOC試験 用量設定試験 小児用医薬品の開発促進 Pandemic Crisisから学んだこと 日本におけるAdaptive Design 医薬品開発における品質改善 Lean Six Sigma Therapeutic Risk Mangement PMS 意義のある安全性情報を提供するために 臨床研究の活性化の方策 本年会を通じて 製薬業界 アカデミア 規制当局がそれぞれの立場を 理解し 医薬品開発の効率化の促進に寄与できるものと祈念しています アステラス製薬株式会社 首藤 英利 株式会社LOTUS 一般財団法人 日本製薬医学会 高橋 希人 卓上展示あり 昭和大学 内田 日本語 英語間の同時通訳あり 直樹 独立行政法人 宇山 佳明 医薬品医療機器総合機構 グラクソ スミスクライン株式会社 吉永 寿一 プログラムアドバイザー 独立行政法人 医薬品医療機器総合機構 独立行政法人 医薬品医療機器総合機構 森 伹野 和彦 恭一 プログラムコーディネーター 鳥居薬品株式会社 工藤 稔 後援 厚生労働省 医薬品医療機器総合機構 日本製薬工業協会 DIAホームページ よりオンライン申込も受付中です ドラッグ インフォメーション アソシエーション エルエルシー 東京都千代田区岩本町 マルエイビル4階 Tel: Fax: Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China

10 :00 10: :30 11:00 5 DIA Paul Pomerantz DIA Advisory Council of Japan 2010 DIA AWARDS 11:00 11: :40 12:20 2 Capability 11:00 12: :20 13: :20 14:50 1 TRACK A 5 TRACK B 2 TRACK C E. Stewart Geary 1 13:20-13:50 A Personal View of Personalized Medicine Pfizer Global Research and Development Dominic G. Spinella 13:50-14:20 14:20-14:50 13:20-13:50 13:50-14:20 14:20-14:50 13:20-13:50 13:50-14:20 14:20-14:50

11 11 14:50 15: :20 17:20 2 TRACK A 5 TRACK B 2 TRACK C :20-15:50 15:50-16:20 Medical Products Agency Kristina Dunder 16:20-17: :20-15:50 i3 Drug Safety K. Arnold Chan 15:50-16:15 MSD 16:15-16:40 16:40-17: :20-16:00 16:00-16:30 16:30-17:20 17:45 19:30 2

12 :30 9:00 2 9:00 10:30 3 TRACK A 5 1 TRACK B 2 1 LOTUS TRACK C 2 9:00-9:25 FDA Dianne Murphy 9:25-9:50 3 European Medicines Agency Agnès Saint Raymond 9:50-10:10 10:10-10:30 9:00-9:20 9:20-9:40 United BioSource Corporation David S. Miller 9:40-10:00 10:00-10:20 9:00-9:10 Overview 9:10-9:30 9:30-9:50 9:50-10: :30 11:00 2

13 13 11:00 12:30 4 Presentation Title to Be Confirmed TRACK A 5 2 Executive Director, Translational and Molecular 11:00-11:30 TRACK B 2 TRACK C 2 2 LOTUS Continual Process Improvement: Lean Six Sigma 11:00-11:30 11:30-12: :00-11:20 11:20-11:40 11:40-12:00 Seoul National University College of Medicine & Hospital In-Jin Jang 12:00-12: :00-11:40 11:40-12:00 12:00-12:20 日本イーライリリー株式会社 12:20-12:30 12:30 13:30 2

14 14 13:30 15: :30 17:30 5 DIA Advisory Council of Japan European Medicines Agency Thomas Lönngren FDA Murray M. Lumpkin 17:30 17:45 15:00 15: : DIA 14 CDM -3D Age: <Data, Diversity, Direction> DIA Regulatory Affairs DIA DIA

15 15 1 9:00 2 8: :20-19:30 2 9:00-17: :45-19:30 2 DIA 1 18, , Tel Fax [email protected] URL: Private Social Function Policy 当会議開催期間中の 当プログラム外の会議 展示 懇親会等のイベントの開催は ご遠慮ください 下記時間帯につきましては これに限りません 10 月 27 日 ( 水 ) 終日 10 月 28 日 ( 木 ) 7:00 ~ 10:00 20:00 以降 10 月 29 日 ( 金 ) 7:00 ~ 8:45 18:00 以降 特に公表しない限り 本ワークショップにて発表される内容は発表者本人の見解であり 所属する組織 あるいは DIA のものとは限りません 発表者および講演タイトルは予告なく変更されることがあります 書面における合意なく DIA ワークショップの情報を録音することは いかなる形態であっても禁止されています DIA Tel: Fax: [email protected]

16 DIA 日本事務所 FAX: 会議参加申込書 東京都千代田区岩本町 マルエイビル 4 階 TEL: 第 7 回 D I A 日本年会 [ カンファレンス ID #10303] 2010 年 10 月 28~29 日 タワーホール船堀東京都江戸川区船堀 参加申込方法 DIA ホームページ ( よりお申し込み頂くか この申込書に必要事項をご記入の上 FAX にてお申し込みください 受理後 5 営業日以内に e メールにて申込受領書を送付いたします 参加費用 ( 該当する にチェックしてください ) 会員資格が失効している方 および 非会員の方は 会員登録 ( 更新 ) することにより 会員価格にてご参加いただけます また DIA 各種機関紙の入手 DIA ウェブサイトの会員専用ページへのアクセス等 種々の特典が得られます ご不明な点等ございましたら DIA 日本事務所までお問い合わせください 参加申し込みはカンファレンス当日も受付けています 会員 一般 非会員 表示は税込価格です参加費合計 早期割引 2010 年 10 月 1 日までのお申込み 61,950 61, 年 10 月 2 日以降のお申込み 67,200 67,200 政府関係 26,250 26,250 非営利団体 / 大学関係 26,250 26,250 学生 10,500 10,500 請求書をご希望の方は下の にチェックを入れてください 請求書を希望します 出展ご希望の方は下記までご連絡をお願いします [email protected] DIA 日本事務所使用欄 会員登録する 登録費 15,750 会員登録しない 一般 早期割引 2010 年 10 月 1 日までのお申込み 2010 年 10 月 2 日以降のお申込み政府関係非営利団体 / 大学関係学生一般政府関係非営利団体 / 大学関係学生 61,950 77,700 67,200 82,950 26,250 42,000 26,250 42,000 10,500 26,250 82,950 82,950 42,000 42,000 42,000 42,000 10,500 10,500 Date No. 受領書送付 Invoice 入金 お支払方法本申込書でのお支払いは 銀行振込のみとなります [ 振込先 ] シティバンク赤坂支店普通口座 口座名 :Drug Information Association ご入金の際は ご依頼人の欄に必ず参加者名および会社名を記載してください 同一会社で複数の方の参加費を同時に振り込まれる場合は 書面にて参加者名と振込み日をDIA 日本事務所までお知らせください 振込みに関する諸手数料は 振込人負担にてお願いいたします クレジットカードでのお支払いをご希望の方は DIAホームページ ( よりオンラインにてお申し込みください アルファベット ( 英語 ) でご記入ください Last Name( 姓 ) First Name( 名 ) Middle Name Degrees Dr. Mr. Ms. Job Title Affiliation (Company) Address City State Zip/Postal Country ( 必須 ) Phone Number( 必須 ) Fax Number * 参加のキャンセルは お申込み受理後 2010 年 10 月 21 日までは手数料として一般会員 非会員とも 21,400 円 政府 / 大学関係者については会員 非会員とも 10,700 円を申し受けます それ以降のキャンセルについては参加費全額を申し受けますのでご注意ください 同一会社からの代理参加も可能ですが その際はお早めに必ず DIA 日本事務所までお知らせください ( 会員資格の譲渡はできませんので 非会員としての参加費を申し受ける場合があります ) 参加をキャンセルされる際には 必ず書面にて DIA 日本事務所まで また 宿泊のキャンセルは直接ホテルまでご連絡願います 会場は変更される場合がありますので予めご了承ください DIA が取り扱う個人情報について お申し込みいただいた個人情報は DIA からの会議案内送付等の目的にのみ使用させていただきます