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5 th Annual Conference in Japan for Asian New Drug Development May 10-11, 2011 Tokyo Dome Hotel 1-3-61 Koraku, Bunkyo-ku, Tokyo 112-8562, Japan PROGRAM CHAIRPERSON Hironobu Saito, PhD Daiichi Sankyo Co., Ltd., Japan PROGRAM SUB-CHAIRPERSONS Herng-Der Chern, MD, PhD Center for Drug Evaluation, Chinese Taipei Yil-Seob Lee, MD, PhD GlaxoSmithKline Korea, Republic of Korea Ling Su, PhD Novartis Pharma, P.R. China PROGRAM COMMITTEE Weon Do sanofi-aventis Korea, Republic of Korea Keiko Ebihara MSD K.K., Japan Noriaki Murao Merz Pharmaceuticals GmbH, Japan Keiko Oishi CMIC Co., Ltd., Japan Yoshihiko Ono Pfizer Japan Inc., Japan Junko Sato, PhD Pharmaceuticals and Medical Devices Agency, Japan Sang-Goo Shin, MD, PhD Korea National Enterprise for Clinical Trials Seoul National University College of Medicine, Republic of Korea Yoshinobu Tanaka MSD K.K., Japan Meir-Chyun Tzou, PhD Food and Drug Administration, Department of Health, Chinese Taipei Yoshiaki Uyama, PhD Pharmaceuticals and Medical Devices Agency, Japan Spring C. Wang, MD Cephalon, Inc., P.R. China Ping Xu, PhD EPS China Co., Ltd., P.R. China EPS International Co., Ltd., Japan PROGRAM ADVISORS Jaw-Jou Kang, PhD Food and Drug Administration, Department of Health, Chinese Taipei Kazuhiko Mori Pharmaceuticals and Medical Devices Agency, Japan Won Shin, PhD Korea Food and Drug Administration, Republic of Korea Kyoichi Tadano, PhD Pharmaceuticals and Medical Devices Agency, Japan PROGRAM COORDINATOR Junichi Nishino Novartis Pharma K.K., Japan The fourth annual conference for Asian new drug development was held in Tokyo in April, 2010. Several issues about Asian development were discussed intensively from the sponsor s and the regulatory reviewer s point of view. For the fifth conference, the program committee has been joined by colleagues from East Asian countries China, the Republic of Korea, Chinese Taipei, and Japan who are actively involved in drug development in Asia. Nowadays, the practical organizations for Asian collaboration have been set up and several fruitful outcomes have been published. The more critical topics have been selected. Main topics are as follows: 1) Oncology 2) Pharmacogenomics 3) Safety Reporting, Pharmacovigilance 4) GCP Compliance and Inspection Several experts in drug development from China, the Republic of Korea, Chinese Taipei, and Japan will share their experiences and discuss how we can contribute to healthcare and the patients in Asia. We are also planning for opportunities for substantive discussion with Asian regulators including PMDA in order to develop new drugs which contribute to public health. WHO SHOULD ATTEND This program will benefit the following individuals Clinical development professionals Personnel involved in regulatory affairs Personnel at clinical study sites Personnel at CROs and SMOs Tabletop Exhibit Opportunity Please contact DIA Japan for details about tabletop exhibits. Tel: +81-3-5575-2130 Fax: +81-3-3583-1200 email: diajapan@diajapan.org. 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 DAY 1 TUESDAY, MAY 10, 2011 12:30 13:30 LUNCH BREAK Free lunch is available in Tenku - A (B1F) 9:00 10:30 CONFERENCE REGISTRATION Tenku (B1F) 10:30 11:00 WELCOME AND OPENING REMARKS Tenku - B (B1F) Ko Sekiguchi, MBA, MCP Director, DIA Japan, LLC, Japan Tatsuo Kurokawa, PhD Chair, DIA Advisory Council of Japan Professor, Division of Regulatory Sciences, Faculty of Pharmacy, Keiko University, Japan Hironobu Saito, PhD Director, Global Regulatory Management Group, New Drug Regulatory Affairs Department, R&D Division, Daiichi Sankyo Co., Ltd., Japan 11:00 12:30 KEYNOTE SESSION Tenku - B (B1F) Kyoichi Tadano, PhD Division Director, International Affairs and Human Resources Development Division, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Noriaki Murao Representative, Japan Representative Office, Merz Pharmaceuticals GmbH, Japan 11:00 11:45 KEYNOTE 1 A New Paradigm for Medical Products Regulation in Taiwan Herng-Der Chern, MD, PhD Distinguished Research Fellow, Center for Drug Evaluation (CDE), Chinese Taipei 11:45 12:30 KEYNOTE 2 Asia Development in the Global Frame: US/EUbased Multi-National Pharma view Yosuke Tanaka, MBA Vice President, Head of Global Project Management Asia, Bayer HealthCares Company Ltd., P.R. China 13:30 15:20 SESSION 1 Tenku - B (B1F) Oncology Part 1: Asian Leadership for Regionally Common Cancers Yil-Seob Lee, MD, PhD, MBA Head of Medical and Regulatory, GlaxoSmithKline Korea, Republic of Korea Yoshinobu Tanaka Assistant Director, Oncology Group, Clinical Science, Japan Development, MSD K.K., Japan 13:30 13:55 Needs for Regional Clinical Development on Oncology in Asia Yung-Jue Bang, MD, PhD Professor, Internal Medicine, Seoul National University College of Medicine, Republic of Korea 13:55 14:20 Regulatory Support and Consideration in the Design of Regional Clinical Trials of Oncology: Taiwan s Experience Herng-Der Chern, MD, PhD Distinguished Research Fellow, Center for Drug Evaluation (CDE), Chinese Taipei 14:20 14:55 Experience on Regional Clinical Development in Oncology Toshihiko Doi, MD, PhD Deputy Chief of Gastroenterology & GI Oncology Department, Director of Clinical Trial Management Office, National Cancer Center Hospital East, Japan 14:55 15:20 Proposal for Regional Clinical Development in Oncology Hanlim Moon, MD, PhD Oncology Medical Director, China and Asia R&D China and Global Oncology, GlaxoSmithKline, P.R. China Contact and Exhibit Information For meeting and tabletop exhibit information, please contact DIA Japan in Tokyo by: Telephone: +81-3-5575-2130 Fax: +81-3-3583-1200 email: diajapan@diajapan.org If you are interested in obtaining space for a tabletop exhibit, please check the box in the REGISTRATION FEE area on page 6.

3 15:20 15:50 COFFEE BREAK Tenku - A (B1F) 15:50 17:30 SESSION 2 Tenku - B (B1F) Oncology Part 2: Safety Reporting in Clinical Trials Herng-Der Chern, MD, PhD Distinguished Research Fellow, Center for Drug Evaluation (CDE), Chinese Taipei Junko Sato, PhD Director for Risk Management, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 15:50 16:10 Ensuring the Safety of the Patient: Effective Execution of Oncology Trials Patti Compton Senior Director, Development Operation, Development Japan, Pfizer Japan Inc., Japan 16:10 16:30 Safety Report: Evaluation Method in Agency Tomoko Okudaira Reviewer, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 9:15-9:40 Inspection Experience by USFDA at CRU Tsuyoshi Momma, BPh, MSc Deputy Center Director, Clinical Pharmacology Center, Medical Co. LTA (Sousei-kai), Japan 9:40-10:05 Inspection Experiences of Clinical Sites by Foreign Regulatory Agencies Lisa Sun, MD, MPH Senior Auditor - Asia Pacific, Global Quality & Regulatory Compliance, Bristol-Myers Squibb, P.R. China 10:05-10:30 GCP Inspection by PMDA Emiko Kondo Director, Office of Conformity Audit, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 10:30-10:55 Company Audit for Asian Sites and Japan Sites Kiyomi Hirayama Manager, Global Clinical Compliance, MSD K.K., Japan 10:55-11:25 COFFEE BREAK Tenku - A (B1F) 16:30 17:30 Panel Discussion Panelists: All Speakers from Sessions 1 and 2 17:45 19:30 RECEPTION Tenku - A (B1F) DAY 2 WEDNESDAY, MAY 11, 2011 8:30 9:15 CONFERENCE REGISTRATION Tenku (B1F) 9:15 10:55 SESSION 3 Tenku - B (B1F) GCP Inspection to Asian Sites Keiko Oishi Senior Managing Director and COO, International Business and Corporate Development, CMIC Co., Ltd., Japan Keiko Ebihara Director, Regulatory and Vaccine Policy Group, Public and Industry Policy Office, MSD K.K., Japan 11:25-13:05 SESSION 4 Tenku - B (B1F) Importance of Pharmacogenomics in the East Asian Population Yoshiaki Uyama, PhD Director, Division of Regulatory Science Research, Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Sang-Goo Shin, MD, PhD President, Korea National Enterprise for Clinical Trials (KoNECT), MOHW, Professor of Clinical Pharmacology, Seoul National University College of Medicine, Republic of Korea 11:25-11:50 Korean Activities to Realize PGx-based Medicine Jae-Gook Shin, MD, MS, PhD Professor and Chair, Department of Pharmacology and Clinical Pharmacology Director, Pharmacogenomics Research Center, Inje University College of Medicine, Director, Clinical Trial Center, Inje University Busan Paik Hospital, Republic of Korea 11:50-12:15 HLA-B*1502 Screening in Taiwan to Prevent Carbamazepine-Induced Stevens-Johnson Syndrome) Chen-Yang Shen, PhD Professor/Research Fellow, Institute of Biomedical Sciences, Academia Sinica, Chinese Taipei

4 12:15-12:40 Usefulness of Pharmacogenomics in Japanese Population Based on Latest Scientific Knowledge Junichi Azuma, MD Professor, Division of Clinical Phamacogenomics, Hyogo University of Health Sciences, Japan 12:40-13:05 Omics Project in PMDA Yasuto Otsubo, MS Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 13:05 14:05 LUNCH BREAK Free lunch is available in Tenku - A (B1F) 14:05-15:15 SESSION 4 continued Tenku - B (B1F) Importance of Pharmacogenomics in the East Asian Population Yoshiaki Uyama, PhD Director, Division of Regulatory Science Research, Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Sang-Goo Shin, MD, PhD President, Korea National Enterprise for Clinical Trials (KoNECT), MOHW, Professor of Clinical Pharmacology, Seoul National University College of Medicine, Republic of Korea Panel Discussion Panelists: All Speakers from Session 4 15:45-17:15 SESSION 5 Tenku - B (B1F) Ask the Asian Regulatory Experts Hironobu Saito, PhD Director, Global Regulatory Management Group, New Drug Regulatory Affairs Department, R&D Division, Daiichi Sankyo Co., Ltd., Japan Yoshihiko Ono Director, Regulatory Policy & Intelligence, Pfizer Japan Inc., Japan Panelists: Yoshiaki Uyama, PhD Director, Division of Regulatory Science Research, Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Herng-Der Chern, MD, PhD Distinguished Research Fellow, Center for Drug Evaluation (CDE), Chinese Taipei Sang-Goo Shin, MD, PhD President, Korea National Enterprise for Clinical Trials (KoNECT), MOHW, Professor of Clinical Pharmacology, Seoul National University College of Medicine, Republic of Korea Speaker Invited P.R. China 17:15 17:30 CLOSING REMARKS Tenku - B (B1F) Hironobu Saito, PhD Director, Global Regulatory Management Group, New Drug Regulatory Affairs Department, R&D Division, Daiichi Sankyo Co., Ltd., Japan 15:15 15:45 COFFEE BREAK Tenku - A (B1F) 17:30 WORKSHOP ADJOURNED 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.

5 General Information REGISTRATION: Registration will start at 9:00 on the first day, and at 8:30 on the second day, at the room Tenku on the 1st basement floor. EXHIBITION: Tuesday, May 10, 12:30 19:30 in the room Tenku-A on the 1st basement floor. Wednesday, May 11, 9:00 15:45 in the room Tenku-A on the 1st basement floor. RECEPTION: Tuesday, May 10, 17:45 19:30 in the room Tenku-A on the 1st basement floor. HOTEL: There are a limited number of rooms at the Tokyo Dome Hotel at the reduced rates shown below. Room availability at this rate is guaranteed only until April 20, 2011 or until the room block is filled. Attendees should make their airline and room reservations as soon as possible. Single 19,835/night Twin 25,075/night Address: 1-3-61 Koraku, Bunkyo-ku, Tokyo 112-8562, Japan Telephone: +81-(0)3-5805-2111 Fax: +81-(0)3-5805-2131 URL: http://www.tokyodome-hotels.co.jp/e/index.html To reserve a room, please contact the Tokyo Dome Hotel above and mention the DIA Workshop. To reserve a room at the reduced rates for DIA, attendees must use the Hotel Reservation Request Form from the Tokyo Dome Hotel. To download this form, go to http://www.diahome.org/productfiles/24457/11302_hotel_form.pdf or CLICK HERE. Upcoming Events BEGINNING JUNE, 2011 Tokyo, Japan 4 th DIA Regulatory Affairs Training Course (10 Sessions) Program Chair: Keiko Ebihara MSD K.K., Japan JUNE 19-23, 2011 Chicago, IL, USA DIA 2011: 47 th Annual Meeting Program Chair: Kenneth A. Getz, MBA CISCRP and Tufts Center for the Study of Drug Development, USA SEPTEMBER 5-6, 2011 Tokyo, Japan 2 nd Cardiac Safety Workshop in Japan Program Chair: Boaz Mendzelevski, MD CoreLab Partners Inc., UK OCTOBER 27-28, 2011 Tokyo, Japan 8 th DIA Japan Annual Meeting Program Chair: Satoshi Toyoshima, PhD Japan Pharmacists Education Center, Japan 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. Monday, May 9 All times are acceptable Tuesday, May 10 Before 9:00 and after 20:00 Wednesday, May 11 Before 8:30 and after 18:00

REGISTRATION FORM: Register online or forward to DIA Japan, Nisso 22 Building 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japan tel +81-3-5575-2130 fax +81-3-3583-1200 5th Annual Conference in Japan for Asian New Drug Development Event #11302 May 10-11, 2011 Tokyo Dome Hotel, 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. APRIL 22, 2011 APRIL 22, 2011 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! www.diahome.org/membership Nonmember Fee MEMBERSHIP 15,750 82,950 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 Tokyo Dome Hotel at the reduced rates shown below. Room availability at this rate is guaranteed only until April 20, 2011 or until the room block is filled. Attendees should make their airline and room reservations as soon as possible. Single 19,835/night / Twin 25,075/night Address: 1-3-61 Koraku, Bunkyo-ku, Tokyo 112-8562, Japan Telephone: +81-(0)3-5805-2111 Fax: +81-(0)3-5805-2131 URL: http://www.tokyodome-hotels.co.jp/e/index.html To reserve your room, please contact the Tokyo Dome Hotel above and mention the DIA Workshop or click here for the Hotel Reservation Form. CANCELLATION POLICY: On or before APRIL 28, 2011 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 TABLETOP EXHIBIT INFORMATION Attendees may visit the tabletop exhibits during the event and receptions. Contact DIA Japan in Tokyo. Please check the applicable category: Academia Government Industry CSO (Contract research/service organization) Student (Call for registration information) Telephone +81-(0)3-5575-2130 Fax +81-(0)3-3583-1200 email diajapan@diajapan.org 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 www.diahome.org 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 2-13-10, Chiyoda-ku, Tokyo 100-0014, Japan Drug Information Association Ordinary Account Number: 7585284, 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 # email Required for confirmation Phone Number Required Fax Number PAYMENT BY CREDIT CARD is available online only www.diahome.org

第 5 回 DIA アジア新薬開発カンファレンス 2011 年 5 月 10 日 ( 火 )~11 日 ( 水 ) 東京ドームホテル 112-8562 東京都文京区後楽 1-3-61 プログラム委員長第一三共株式会社齋藤宏暢 プログラム副委員長 Center for Drug Evaluation Herng-Der Chern GlaxoSmithKline Korea Yil-Seob Lee Novartis Pharma Ling Su プログラム委員 sanofi-aventis Korea Weon Do MSD 株式会社海老原惠子メルツファーマシューティカルズ村尾典昭シミック株式会社大石圭子ファイザー株式会社小野嘉彦独立行政法人医薬品医療機器総合機構佐藤淳子 Korea National Enterprise for Clinical Trials Seoul National University College of Medicine Sang-Goo Shin MSD 株式会社田中義信 Food and Drug Administration, Department of Health Meir-Chyun Tzou 独立行政法人医薬品医療機器総合機構宇山佳明 Cephalon, Inc. Spring C. Wang EPS China Co., Ltd. EPS インターナショナル株式会社許平 プログラムアドバイザー Food and Drug Administration, Department of Health Jaw-Jou Kang 独立行政法人医薬品医療機器総合機構森和彦 Korea Food and Drug Administration Won Shin 独立行政法人医薬品医療機器総合機構伹野恭一 プログラムコーディネーターノバルティスファーマ株式会社西野潤一 概要 2010 年 4 月に第 4 回 DIA アジア新薬開発カンファレンスが開催され 医薬品開発に関わる企業並びに規制当局の関係者が多数集まり アジア諸国における医薬品開発に関する活発な議論が行われました 最近では アジア諸国間における協調体制が確立され 具体的成果が種々の領域や薬剤にて公表されるようになりました このような現状から 第 5 回のカンファレンスでは アジア地域における重要なトピックとして 以下を選びました 1. アジア特異的薬剤の開発 1 アジアにおける特異的疾患の治療薬の開発 2 アジア特有の疾患の治療薬の開発 (1) 癌領域 (2) ファーマコゲノミクス (3) 安全性報告とファーマコビジランス (4) GCP コンプライアンスと査察 演者として 中国 韓国 台湾等の地域から 医薬品開発に関する専門家を招聘し お互いの経験を共有し アジアでのヘルスケアと患者に対して貢献するために活発に議論を行う予定です 更に日本を含むアジア各国の審査担当者と アジア地域の国民の健康に貢献する新しい医薬品開発を目指して議論する場を設けます 参加対象このプログラムは下記に従事されている方に特に有益です 臨床開発ご担当者 薬事ご担当者 治験現場でのご担当者 CROおよびSMOご担当者 卓上展示申込受付中詳細については DIA Japan までお問い合わせください Tel: 03-5575-2130 Fax: 03-3583-1200 E-mail: diajapan@diajapan.org 日本語 英語間の同時通訳あり DIA ホームページ (www.diahome.org) よりオンライン申込も受付中です ディー アイ エージャパン 106-0041 東京都港区麻布台 1-11-10 日総第 22 ビル 7F Tel: 03-5575-2130 Fax: 03-3583-1200 E-mail: diajapan@diajapan.org 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 1 日目 2011 年 5 月 10 日 ( 火 ) 9:00 10:30 受付地下 1 階天空 10:30 11:00 開会の挨拶地下 1 階天空 B DIA 日本代表関口康 DIA Advisory Council of Japan 議長慶応義塾大学黒川達夫 第一三共株式会社齋藤宏暢 11:00 12:30 基調講演地下 1 階天空 B 座長独立行政法人医薬品医療機器総合機構伹野恭一メルツファーマシューティカルズ村尾典昭 11:00 11:45 基調講演 1 A New Paradigm for Medical Products Regulation in Taiwan Center for Drug Evaluation (CDE) Herng-Der Chern 11:45 12:30 基調講演 2 グローバル開発の中のアジア開発 Bayer HealthCare Company Ltd. 田中洋介 13:30 15:20 セッション 1 地下 1 階天空 B Oncology Part 1: Asian Leadership for Regionally Common Cancers 座長 GlaxoSmithKline Korea Yil-Seob Lee MSD 株式会社田中義信 13:30 13:55 Needs for Regional Clinical Development on Oncology in Asia Seoul National University College of Medicine Yung-Jue Bang 13:55 14:20 Regulatory Support and Consideration in the Design of Regional Clinical Trials of Oncology: Taiwan s Experience Center for Drug Evaluation (CDE) Herng-Der Chern 14:20 14:55 Experience on Regional Clinical Development in Oncology 独立行政法人国立がん研究センター東病院土井俊彦 14:55 15:20 Proposal for Regional Clinical Development in Oncology GlaxoSmithKline Hanlim Moon 15:20 15:50 コーヒーブレイク地下 1 階天空 A 12:30 13:30 ランチブレイク地下 1 階天空 A 軽食をご用意しております 会議 展示についてのお問い合わせ 会議 展示についてご質問などございましたら DIA Japan までお問い合わせください Tel: 03-5575-2130 Fax: 03-3583-1200 email: diajapan@diajapan.org

3 15:50 17:30 セッション 2 地下 1 階天空 B Oncology Part 2: Safety Reporting in Clinical Trials 座長 Center for Drug Evaluation (CDE) Herng-Der Chern 独立行政法人医薬品医療機器総合機構佐藤淳子 15:50 16:10 Ensuring the Safety of the Patient: Effective Execution of Oncology Trials ファイザー株式会社 Patti Compton 9:40-10:05 Inspection Experiences of Clinical Sites by Foreign Regulatory Agencies Bristol-Myers Squibb Lisa Sun 10:05-10:30 GCP Inspection by PMDA 独立行政法人医薬品医療機器総合機構近藤恵美子 10:30-10:55 Company Audit for Asian Sites and Japan Sites MSD 株式会社平山清美 16:10 16:30 Safety Report: Evaluation Method in Agency 独立行政法人医薬品医療機器総合機構奥平朋子 16:30 17:30 パネルディスカッションパネリスト : セッション1および2の講演者 17:45 19:30 レセプション地下 1 階天空 A 2 日目 2011 年 5 月 11 日 ( 水 ) 8:30 9:15 受付地下 1 階天空 9:15 10:55 セッション 3 地下 1 階天空 B GCP Inspection to Asian Sites 座長シミック株式会社大石圭子 MSD 株式会社海老原惠子 9:15-9:40 Inspection Experience by USFDA at CRU 医療法人相生会臨床薬理センター門間毅 10:55-11:25 コーヒーブレイク地下 1 階天空 A 11:25-13:05 セッション 4 地下 1 階天空 B Importance of Pharmacogenomics in the East Asian Population 座長独立行政法人医薬品医療機器総合機構宇山佳明 Korea National Enterprise for Clinical Trials (KoNECT), Seoul National University College of Medicine Sang-Goo Shin 11:25-11:50 Korean Activities to Realize PGx-based Medicine Inje University College of Medicine, Inje University Busan Paik Hospital Jae-Gook Shin 11:50-12:15 HLA-B*1502 Screening in Taiwan to Prevent Carbamazepine-Induced Stevens-Johnson Syndrome Institute of Biomedical Sciences, Academia Sinica Chen-Yang Shen 12:15-12:40 最近の知見に基づく日本人におけるゲノム薬理学の有用性兵庫医療大学東純一 12:40-13:05 Omics Project in PMDA 独立行政法人医薬品医療機器総合機構大坪泰斗

4 13:05 14:05 ランチブレイク地下 1 階天空 A 軽食をご用意しております 14:05-15:15 セッション 4 ( 続き ) 地下 1 階天空 B Importance of Pharmacogenomics in the East Asian Population 座長独立行政法人医薬品医療機器総合機構宇山佳明 Korea National Enterprise for Clinical Trials (KoNECT), Seoul National University College of Medicine Sang-Goo Shin パネルディスカッションパネリスト : セッション4の講演者 15:45-17:15 セッション 5 地下 1 階天空 B Ask the Asian Regulatory Experts 座長第一三共株式会社齋藤宏暢ファイザー株式会社小野嘉彦 パネリスト : 独立行政法人医薬品医療機器総合機構宇山佳明 Center for Drug Evaluation (CDE) Herng-Der Chern Korea National Enterprise for Clinical Trials (KoNECT), Seoul National University College of Medicine Sang-Goo Shin From China Speaker Invited 15:15 15:45 コーヒーブレイク地下 1 階天空 A 17:15 17:30 閉会の挨拶地下 1 階天空 B 第一三共株式会社齋藤宏暢 17:30 カンファレンス終了 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.

5 ご案内 登録受付開始時間 : 1 日目 9:00 2 日目 8:30 場所 : 地下 1 階天空 企業展示展示時間 : 1 日目 12:30 19:30 2 日目 9:00 15:45 場所 : 地下 1 階天空 A レセプション時間 : 1 日目 17:45 19:30 場所 : 地下 1 階天空 A ホテル東京ドームホテルにて 下記 DIA 特別料金をご用意しております シングル 1 泊 19,835 円 ツイン 1 泊 25,075 円 ( 上記は朝食付の料金です ) この特別料金は 専用の予約フォーム ( 下記リンクよりダウンロード可 ) にてご予約いただいた方に限り適用させていただきます 部屋数に限りがございますので お早めにご予約ください 専用予約フォーム : http://www.diahome.org/productfiles/24457/11302_ Hotel_Form.pdf < 東京ドームホテル> 住所 : 112-8562 東京都文京区後楽 1-3-61 Tel: 03-5805-2111 Fax: 03-5805-2131 URL: http://www.tokyodome-hotels.co.jp/ DIA 会議今後の開催予定 第 4 回 Regulatory Affairs トレーニングコース 2011 年 6 月開始 ( 全 10 回 ) 東京プログラム委員長 MSD 株式会社海老原恵子 第 47 回 DIA アニュアルミーティング 2011 年 6 月 19 日 23 日シカゴプログラム委員長 Kenneth A. Getz, MBA CISCRP and Tufts Center for the Study of Drug Development, USA 第 2 回カーディアック セーフティ ワークショップ 2011 年 9 月 5 日 6 日東京プログラム委員長 Boaz Mendzelevski, MD CoreLab Partners Inc., UK 第 8 回 DIA 日本年会 2011 年 10 月 27 日 28 日東京プログラム委員長財団法人日本薬剤師研修センター豊島聰 Private Social Function Policy 当会議開催期間中 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 5 月 9 日 ( 月 ) 終日 5 月 10 日 ( 火 ) 9:00 以前 20:00 以降 5 月 11 日 ( 水 ) 8:30 以前 18:00 以降

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