8th DIA Annual Conference in Japan for Asian New Drug Development Value and Quality of East Asian Clinical Trial in Drug Development May 22-23, 2014 | Sola City Hall | Ochanomizu, Tokyo  Fo or more information visit diahome.org/Japan-8thNewDrugDev OVERVIEW PROGRAM CHAIR Hidetoshi Shuto, MS Astellas Pharma Inc. PROGRAM VICE-CHAIR Ari Fujishiro Daiichi Sankyo Co., Ltd. PROGRAM COMMITTEE Tomohisa Hayakawa, PhD EPS International Holdings Co., Ltd. Shii Man, MD, PhD Otsuka Beijing Research Institute, China Koichi Miyazaki, MSc, RPh Daiichi Sankyo Co., Ltd. Yasuto Otsubo Pharmaceuticals and Medical Devices Agency Min Soo Park, MD, PhD Yonsei University College of Medicine Republic of Korea Kihito Takahashi, MD, PhD GlaxoSmithKline K.K. Drug development in East Asia has become extremely vigorous as the interests of organizations related to drug development expand. Such organizations are now not only interested in the advancement of drug development, but also the maximization of generated value and the improvement of quality in new drug development. In order to facilitate drug discovery under the revised regulations for optimal regulatory circumstances, professionals involved in drug development face various challenges. Furthermore, collaboration to work towards drug discovery beyond each country’s boundaries is strongly desired in this era of globalization of drug development. In this conference, together with experts from industry and CRO, speakers from regulators and academia in Japan, China and Korea will share information and experiences regarding the current situation of new drug development in the emerging East Asia region, and provide advice on how to improve the value and quality of new drugs. The 8th DIA Annual Conference in Japan for Asian New Drug Development will feature discussion on all stages of drug development, with sessions focused on the following topics: • Latest regulatory information • Early phase clinical trial • Collaboration between academic organizations • Regulatory inspection • Regional study communications • Late phase development strategy Akio Uemura, PhD Allergan Japan K.K. We look forward to welcoming you to the conference. Yoshiaki Uyama, PhD Pharmaceuticals and Medical Devices Agency WHO SHOULD ATTEND Jisin Yang, MD AstraZeneca K.K. • • • • • • • Clinical development professionals Personnel involved in regulatory affairs Personnel at clinical study sites Personnel at CROs and SMOs Personnel involved in medical affairs and marketing Personnel at academic organization Personnel at agency DIA Global Center 21 Dupont Circle NW, Suite 300 Washington, DC 20036 Worldwide Offices Basel, Switzerland | Beijing, China | Horsham, PA, USA Mumbai, India | Tokyo, Japan www.DIAhome.org Tabletop Exhibit Opportunity For information, contact DIA Japan Nisso 22 Bldg. 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japan Tel: 81-3-5575-2130 | Fax: 81-3-3583-1200 email: [email protected] Simultaneous Translation Available 2 DAY 1 | THURSDAY, MAY 22, 2014 9:30-10:00 REGISTRATION 10:00-10:10 WELCOME AND OPENING REMARKS Ko Sekiguchi Roles of Academia and its Networks for Asian Collaboration in Clinical Trials Yuji Kumagai, MD, PhD Director, Clinical Trial Center, Kitasato Academic Research Organization Representative Director, DIA Japan 10:10-11:30 KEYNOTE SESSION Keynote 1 Academia Collaboration in East Asia: Opportunities and Challenges Haiyan Li, MD Professor of Cardiology, Director of Clinical Trial Center Peking University Third Hospital, China SESSION CHAIR Ari Fujishiro Associate Director, Regulatory Leader, Regulatory Affairs Group, Asia Development Dept., Daiichi Sankyo Co., Ltd. New Drug Development in Asian Region - from Japanese Company Perspective Hidetoshi Shuto Corporate Executive, Astellas Pharma Inc. 14:30– 15:00 COFFEE BREAK 15:00-16:00 SESSION 1 - CONTINUED Part 2: Early Phase and Regional Clinical Trials in Asia SESSION CO-CHAIRS Yasuto Otsubo Keynote 2 SESSION CHAIR Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency Hidetoshi Shuto Jisin Yang, MD Corporate Executive, Astellas Pharma Inc. Clinical Science Director, R&D, AstraZeneca K.K. Strategies for Asia Drug Development: An Integrated Approach Mark Bach, MD, PhD Unique Strategy for Asian Oncology Development in an Early Phase by a Pharmaceutical Company Morihiro Watanabe, MD, PhD Vice President and Head, Asia Pacific Medical Sciences Janssen Pharmaceuticals, Pharmaceutical Companies of Johnson and Johnson, Singapore Head, Clinical Development Center, R&D Japan, North East Asia Hub, Merck Serono Co., Ltd. Early Clinical Trials in Korea Yung-Jue Bang, MD, PhD 11:30-13:00 LUNCH BREAK 13:00-14:30 SESSION 1 Early Phase and Regional Clinical Trials in Asia / Academia Collaboration in East Asia In recent years global clinical trials in East Asia have been increasing with the globalization of drug development. However, most of those trials are conducted as Phase 3 study. Prior sufficient evaluation of the PK/PD similarities of drugs among East Asian regions and between US/EU and other regions is needed for more efficient conduct of global clinical trials in East Asia. Therefore the importance of global clinical trial in Asia from an early stage is becoming higher. In this session speakers from industry and academia will provide their strategies and future visions of new drug development and the role of academia collaboration in East Asia. Finally, the future direction of drug development in East Asia and the issues to be addressed will be discussed. Part 1: Academia Collaboration in East Asia SESSION CO-CHAIRS Yasuto Otsubo Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency Professor of Medical Oncology, Chairman, Dept of Internal Medicine, Seoul National University Hospital, Republic of Korea 16:00-16:15 COFFEE BREAK 16:15-17:30 SESSION 1 – CONTINUED Panel Discussion SESSION CO-CHAIRS Yasuto Otsubo Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency Jisin Yang, MD Clinical Science Director, R&D, AstraZeneca K.K. PANELISTS All Session 1 speakers; Part 1 & Part 2 and Min Soo Park, MD, PhD Director, Clinical Trials Center, Yonsei University College of Medicine, Republic of Korea Jisin Yang, MD Clinical Science Director, R&D, AstraZeneca K.K. Academia Collaboration between Japan and Korea In Jin Jang, MD, PhD Professor of Clinical Pharmacology, Seoul National University, Republic of Korea 17:30-19:00 NETWORKING RECEPTION JOIN A COMMUNITY! Joining a Community is easy, convenient, and free as part of your DIA membership. DIA Communities allow members to exchange information, explore industry hot topics, and build a professional network through a discipline-specific, global or regional Community. Network and share information and ideas through state-of-the-art online media and forums. Go to www.diahome.org/Community 2014 DIA JAPAN EVENT CALENDAR to join the Community of your choice. JUNE 10-11 3rd FDA IND/NDA Training in Japan Kyoto Research Park | Shimogyo, Kyoto To become a DIA member, go to www.diahome.org/membership. JUNE 30 3rd CMC Forum in Japan KFC Hall | Ryogoku, Tokyo SEPTEMBER 10-11 3rd DIA Basic Statistical Concept Workshop for All Clinical Research Professionals in Japan Nomura Conference Plaza | Nihonbashi, Tokyo OCTOBER 23-24 5th DIA Cardiac Safety Workshop KFC Hall | Ryogoku, Tokyo OCTOBER 27-28 4th DIA Project Management Training Course in Japan Urbannet Kanda Conference | Tokyo NOVEMBER 16-18 11th Annual Meeting DIA Japan 2014 Tokyo Big Sight | Ariake, Tokyo DECEMBER 8 2nd DIA Advanced Regulatory Affairs Training Course Urbannet Kanda Conference | Tokyo For more information, please contact: DIA JAPAN OFFICE tel: +81.3.5575.2130 | fax: +81.3.3583.1200 | [email protected] Nisso 22 Building 7F 1-11-10 Azabudai Minato-ku Tokyo 106-0041 Japan 4 DAY 2 | FRIDAY, MAY 23, 2014 8:15-8:30 8:30-9:30 REGISTRATION SESSION 2 Part 1: East-Asian Regulatory Update on Global Clinical Trials With increasing global drug development, regulatory agencies have taken several measures to approve a drug more appropriately. In this session, East Asian regulatory agencies form China, Korea, and Japan will present the latest situation of global clinical trials and regulatory perspectives relating to global drug development. In the panel discussion at the end, various topics will be discussed such as regulatory challenges to evaluate foreign clinical data and to promote Asian regulatory collaboration and global drug development. Questions and comments from participants will be very much appreciated. SESSION CO-CHAIRS Yasuto Otsubo Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency Min Soo Park, MD, PhD Director, Clinical Trials Center Yonsei University College of Medicine, Republic of Korea Global Clinical Data Evaluation for Drug Approval in China Tao Wang Deputy Director, Division II of Clinical Trial for Pharmaceuticals, Center for Drug Evaluation, China Food and Drug Administration, China Global Clinical Data Evaluation for Drug Approval in Korea Myung-Jung Kim Director, Clinical Trials Management Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety, Republic of Korea An Overview of the FDA GCP Inspection Process and Key Remote Presentation via Internet Trends Ann Meeker-O’Connell Senior Director, Clinical Strategy Team Lead, R&D Quality Assurance – Pharma R&D Q&C, Janssen Pharmaceuticals, Inc., United States 9:50-10:20 COFFEE BREAK 10:20-12:30 SESSION 2 - CONTINUED PMDA’s Experiences on Foreign GCP Inspection: Focusing on Asian Region Tomoko Ohsawa, PhD Director for Personnel Coordination, Office of General Affairs, Pharmaceuticals and Medical Devices Agency MFDS’s Perspective of Regulatory Inspection in Korea Ho-Jin Oh Assistant Director, Clinical Trials Management Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety, Republic of Korea Situation of Regulation and GCP Inspection in China Jiangping Dong Division Head, Division of Pharmaceuticals, Department of Drug Registration, China Food and Drug Administration, China Panel Discussion PANELISTS All Session 2 speakers; Part 1 & Part 2 12:30-14:00 LUNCH BREAK Global Clinical Data Evaluation for Drug Approval in Japan Yasuto Otsubo Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency 9:30-9:50 SESSION 2 - CONTINUED Part 2: Trend of GCP Inspection With progress of global clinical development of new drug, numerous clinical trials have been conducted in many countries. Agencies have been conducting GCP inspections in those countries, to ensure the subject’s right and safety, and to demonstrate data reliability of clinical trial. In this session, officers in agencies and experts from Japan, China, Korea, and United State who make efforts for ensuring reliable clinical trialdata will present the inspection process, points of their attention during inspection, and efficient model for building reliability into scientific and operating processes. In panel discussion, the speakers in part 1 and 2 will then discuss recent trend in pharmaceutical regulations and systemic approach for improvement of clinical trial qualitywhich is major issue for industry and clincial site. SESSION CO-CHAIRS Ari Fujishiro Associate Director, Regulatory Leader, Regulatory Affairs Group, Asia Development Dept., Daiichi Sankyo Co., Ltd. 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. Akio Uemura, PhD Wednesday, May 21 All times are acceptable Senior Director, Head of Global Drug Development and Regulatory Affairs Japan, Allergan Japan K.K. Thursday, May 22 Before 8:00 and after 20:00 Friday, May 23 Before 8:00 and after 19:00 5 14:00-15:30 SESSION 3 17:00-18:00 SESSION 3 – CONTINUED Optimal Development Strategies Based on Differences in Culture and Healthcare Setting Panel Discussion Asia has received a lot of attention as a place for multinational clinical studies, with hope for little difference in ethnicity and physical size. It is critical, however, to have a comprehensive understanding of the broad medical environment surrounding health care services such as medical practice, culture, insurance, or drug pricing for smooth execution of clinical studies. Better mutual understanding will minimize the effect of extrinsic factors on drug evaluation. Tomohisa Hayakawa, PhD In the first part, we will listen to suggestions on effective communication for smooth clinical studies in Asia from the viewpoints of sponsor and CRO. In the second session, speakers introduce their experience of post-marketing study in Korea and the health care system in China. A panel discussion by all speakers will provide an opportunity for exchanging opinions on differences in the broad health care environment in Asia, and for a constructive discussion about development strategies that speed the access of patients to medicines. Part 1: Effective and Efficient Communication in Asia Regional Studies SESSION CO-CHAIRS Tomohisa Hayakawa, PhD Corporate Officer / Senior Vice President, EPS International Holdings Co., Ltd. Koichi Miyazaki Associate Director, Asia Development Dept., Daiichi Sankyo Co., Ltd. How Can We Efficiently Manage Asian Studies – From Sponsor’s Perspective Kensuke Morimoto, MSc Manager, Asia Development Dept., Daiichi Sankyo Co., Ltd. Effective Communication in Regional Clinical Studies James Cheong, BSc(Pharm), MBA VP, Clinical Developoment, EPS International, Singapore Phase 3b Studies of Rotigotine Patch in Asian Countries During Regulatory Review Period in Japan Junji Ikeda Director, Clinical R&D, Otsuka Pharmaceutical Co., Ltd. 15:30-16:00 COFFEE BREAK 16:00-17:00 SESSION 3 – CONTINUED Part 2: Development Strategy Based on Healthcare System in Each Country SESSION CO-CHAIRS Tomohisa Hayakawa, PhD Corporate Officer / Senior Vice President, EPS International Holdings Co., Ltd. Koichi Miyazaki Associate Director, Asia Development Dept., Daiichi Sankyo Co., Ltd. NDA Submission of Eribulin Mesilate in Asia “On the NDA Submission in Korea” Tatsuo Watanabe, PhD Senior Director, Medical Planning Section, Oncology HHC Unit Eisai Japan, Eisai Co., Ltd. Medical Administration and the Pharmaceutical Market in China – Present and Future Trend Shingo Shigemura President, CMJ Pharma, China SESSION CO-CHAIRS Corporate Officer / Senior Vice President, EPS International Holdings Co., Ltd. Koichi Miyazaki Associate Director, Asia Development Dept., Daiichi Sankyo Co., Ltd. PANELISTS All Session 3 speakers; Part 1 & Part 2 18:00-18:10 CLOSING REMARKS 18:10 CONFERENCE ADJOURN 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 8th DIA Annual Conference in Japan for Asian New Drug Development Value and Quality of East Asian Clinical Trial in Drug Development TRAVEL AND HOTEL For accommodations at the Tokyo Garden Palace, please visit the following URL to make reservation: http://www.hotelgp-tokyo.com Attendees should make their airline and room reservations as soon as possible. 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First Name M.I.  Dr. Degrees  Mr. All local and overseas charges incurred for the bank transfer must be borne by payer.  Ms. Please include BANK TRANSFER REFERENCE # Job Title PAYMENT BY CREDIT CARD is available online only – www.diahome.org Company Address (As required for postal delivery to your location) City State email Required for confirmation Phone Number Required Fax Number Zip/Postal Country 第8回DIAアジア新薬開発カンファレンス ―医薬品開発におけるアジア開発の価値と質― 2014年5月22日（木）～5月23日（金）ソラシティホール (御茶ノ水) プログラム委員会プログラム委員長アステラス製薬株式会社首藤英利プログラム副委員長第一三共株式会社藤城亜理プログラム委員 EPSインターナショナル株式会社早川智久大塚製薬研発（北京）有限公司満志偉第一三共株式会社宮崎浩一独立行政法人医薬品医療機器総合機構大坪泰斗 Yonsei University College of Medicine Min Soo Park グラクソ・スミスクライン株式会社高橋希人アラガン・ジャパン株式会社植村昭夫独立行政法人医薬品医療機器総合機構宇山佳明アストラゼネカ株式会社プログラム概要東アジア地域での医薬品開発が盛んとなってきている昨今、医薬品開発に関わる方々の興味は医薬品開発の実務推進のみならず、開発により生み出される新薬の価値の最大化、質の向上へと広まりをみせています。最適な医薬品の開発、市販後の管理に向けて行われている規制の改訂に対応し、創薬・育薬のために医薬品開発に関わるものが取り組まなければならないことは多岐に渡ります。さらに、医薬品開発の国際化が進む中、国という枠組みを越えた開発関係者の協働による創薬・育薬に向け、この医薬品開発の推進が期待されています。そこで第8回DIAアジア新薬開発カンファレンスでは、日中韓の規制当局の方並びにアカデミアの方をお招きして、製薬企業及びCROの方とともに、開発の早期からMarket Accessに至るまでのプロセスの中から以下の内容に焦点をあてて、情報や経験の共有及びオープンな意見交換ができる、大変貴重な機会を提供します。 ● 最新の薬事情報 ● 早期臨床試験 ● アカデミア間の協働 ● 薬事査察 ● Regional study communication ● Market Access 東アジア地域での医薬品開発の各方面でご活躍の方々に、各国のアカデミアとの協働の現状、多地域共同臨床試験や上市までのロードマップ等から創薬・育薬の“価値”を、またGCP査察を通じた品質向上に関する行政の考え方等から医薬品開発の“質”に関して、ご講演いただきます。多くの皆さまのご参加を心よりお待ちしております。参加対象者：・　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及びSMOご担当者・　メディカルアフェアー及びマーケティングご担当者・　アカデミアの方・　行政の方梁知身卓上展示申込み受付中 DIA WORLDWIDE HEADQUARTERS 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Tel. +1.215.442.6100 | Fax +1.215.442.6199 WORLDWIDE OFFICES Basel, Switzerland I Beijing, China I Tokyo, Japan Mumbai, India I Washington, DC, USA 詳細については、ディー・アイ・エージャパンまでお問い合わせください。〒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: [email protected] 日本語・英語間の同時通訳あり 2 1日目 | 2014年5月22日（木） 9:30-10:00 参加受付臨床試験におけるアジア連携のためのアカデミアの役割とネットワークの取組み 10:00-10:10 北里大学開会の挨拶熊谷雄治 DIA Japan 関口康 Academia Collaboration in East Asia: Opportunities and Challenges Peking University Third Hospital 10:10-11:30 基調講演 Haiyan Li 基調講演 1 座長：第一三共株式会社 14:30 – 15:00 コーヒーブレイク 15:00-16:00 セッション 1 （続き）藤城亜理 New Drug Development in Asian Region - from Japanese Company Perspective アステラス製薬株式会社第二部: 東アジアにおける早期国際共同治験首藤英利座長：独立行政法人医薬品医療機器総合機構基調講演 2 大坪泰斗座長：アストラゼネカ株式会社アステラス製薬株式会社梁知身首藤英利グローバル製薬企業のアジアにおけるオンコロジー早期開発の新たな取り組み Strategies for Asia Drug Development: An Integrated Approach メルクセローノ株式会社渡部守浩 Janssen Pharmaceuticals Early Clinical Trials in Korea Mark Bach Seoul National University Hospital Yung-Jue Bang 11:30-13:00 13:00-14:30 ランチブレイクコーヒーブレイク 16:15-17:30 セッション 1（続き）セッション 1 東アジアにおける早期国際共同治験及びアカデミアの協働近年、国際共同治験を利用した医薬品開発の増加に伴い、東アジア地域での国際共同治験も着実に増加しているが、多くのアジア共同治験は開発後期の検証試験として実施されている。今後、本地域における医薬品開発をより効率的に実施していくためには、早期より欧米等の他地域との薬物動態/薬力学作用の異同を検討し、なおかつ東アジア民族間・諸国間においても同様の評価を行うことが重要であり、開発早期のアジア共同治験の重要性が高まっている。本セッションでは、これまで実施されたアジア共同治験の事例とともに、開発早期のアジア共同治験に対する企業の戦略及び展望、さらにアジア共同治験におけるアカデミア協働の体制及び役割について紹介するとともに、東アジアにおける今後の医薬品開発の方向性、解決すべき課題について議論する。第一部：東アジアにおけるアカデミアの協働座長：独立行政法人医薬品医療機器総合機構大坪泰斗アストラゼネカ株式会社梁知身 Academia Collaboration between Japan and Korea Seoul National University In Jin Jang 16:00-16:15 パネルディスカッション座長：独立行政法人医薬品医療機器総合機構大坪泰斗アストラゼネカ株式会社梁知身パネリスト：セッション1 第一部・第二部の全演者及び Yonsei University College of Medicine Min Soo Park 17:30-19:00 情報交換会 JOIN A COMMUNITY! Joining a Community is easy, convenient, and free as part of your DIA membership. DIA Communities allow members to exchange information, explore industry hot topics, and build a professional network through a discipline-specific, global or regional Community. Network and share information and ideas through state-of-the-art online media and forums. Go to www.diahome.org/Community 2014 DIA JAPAN EVENT CALENDAR to join the Community of your choice. JUNE 10-11 3rd FDA IND/NDA Training in Japan Kyoto Research Park | Kyoto To become a DIA member, go to www.diahome.org/membership. JUNE 30 3rd CMC Forum in Japan KFC Hall | Ryogoku, Tokyo SEPTEMBER 10-11 3rd DIA Basic Statistical Concept Workshop for All Clinical Research Professionals in Japan Nomura Conference Plaza | Nihonbashi, Tokyo OCTOBER 23-24 5th DIA Cardiac Safety Workshop KFC Hall | Ryogoku, Tokyo OCTOBER 27-28 4th DIA Project Management Training Course in Japan Urbannet Kanda Conference | Tokyo NOVEMBER 16-18 11th Annual Meeting DIA Japan 2014 Tokyo Big Sight | Ariake, Tokyo DECEMBER 8 2nd DIA Advanced Regulatory Affairs Training Course Urbannet Kanda Conference | Tokyo For more information, please contact: DIA JAPAN OFFICE tel: +81.3.5575.2130 | fax: +81.3.3583.1200 | [email protected] Nisso 22 Building 7F 1-11-10 Azabudai Minato-ku Tokyo 106-0041 Japan 4 2日目 | 2014年5月23日（金） 8:15-8:30 参加受付 9:50-10:20 コーヒーブレイク 8:30-9:30 セッション2 10:20-12:30 セッション2 （続き）第一部: 国際共同治験に関する東アジア規制当局の動向 PMDAにおける海外GCP調査の状況医薬品開発の国際化が進む中、各国審査当局はより適切な承認審査のために様々な取り組みを進めている。本セッションでは、中国、韓国及び日本の審査当局担当者の方に、国際共同治験の現状と関連する審査当局での取り組み状況をご紹介いただきます。また、承認審査における海外データの評価を適切に実施するための課題や、今後のアジア連携や国際開発を推進する上での課題等について、パネルディスカッションを行います。フロアからのご質問にもお答えいたします。独立行政法人医薬品医療機器総合機構大澤智子 MFDS’s Perspective of Regulatory Inspection in Korea Ministry of Food and Drug Safety Ho-Jin Oh 中国医薬品管理政策と審査承認状況 China Food and Drug Administration 座長：独立行政法人医薬品医療機器総合機構大坪泰斗 Jiangping Dong パネルディスカッション Yonsei University College of Medicine パネリスト： Min Soo Park セッション2 第一部・第二部の全講演者 Global Clinical Data Evaluation for Drug Approval in China 12:30-14:00 ランチブレイク Center for Drug Evaluation, China Food and Drug Administration Tao Wang Global Clinical Data Evaluation for Drug Approval in Korea Ministry of Food and Drug Safety Myung-Jung Kim 国際共同治験に関するPMDAの動向独立行政法人医薬品医療機器総合機構大坪泰斗 9:30-9:50 セッション2 （続き）第二部: GCP査察の実際新医薬品のグローバル開発の進展に伴い、多くの臨床試験が複数の国で実施され、各規制当局によるGCP査察を通じて、被験者の人権と安全性、及びデータの信頼性が確認されているところですが、アジア地域での各国 GCP査察についての特徴や違いについてはこれまで十分に議論されているとはいえません。本セッションでは、日本、中国、韓国、米国のGCP査察のエキスパートから、各規制当局によるGCP査察がどの様な手順で、どのような点に力が注いで行われているのかという査察の実態や、臨床試験データの信頼性がいかに確保されているのか、また各国特有の見方があるのかという観点で講演をしていただきます。また、パネルディスカッションにおいては、第一部と第二部の演者の方に登壇いただき、最新の薬事規制の動向や臨床試験を実施する企業や施設にとって大きなテーマである臨床試験データの信頼性向上に関し本セッションの演者のご経験を元に議論します。座長：第一三共株式会社藤城亜理アラガン・ジャパン株式会社植村昭夫 An Overview of the FDA GCP Inspection Process and Key Trends（Web経由による講演） Janssen Pharmaceuticals, Inc. Ann Meeker-O Connell Private Social Function Policy 本カンファレンス開催期間中、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。 5月21日（水）終日 5月22日（木）午前8時以前、午後8時以降 5月23日（金）午前8時以前、午後7時以降 5 14:00-15:30 セッション3　17:00-18:00 セッション3 （続き）文化、医療環境の相違を踏まえた最適な開発戦略パネルディスカッション近年、国際共同試験の実施地域として、民族差や体格差が小さいと想定されるアジア地域が広く注目を集めている。しかしながら、円滑な試験実施には、医療習慣や文化の違い、医療保険や薬価制度などの幅広い医療制度、医療を取り巻く環境の相違などを理解する必要がある。相互理解を深めることで、外因性民族的要因が評価に与える影響を最小限に抑えることも期待される。座長：第一部では治験依頼者、CROの立場から、アジア国際共同試験を円滑に実施するためのコミュニケーションのあり方について提言を頂き、第二部では、過去に韓国で実施された市販後臨床試験の事例と、中国における医療制度や医療環境を紹介する。パネルディスカッションでは、第一部、第二部の演者により、臨床試験の実施に留まらず、医薬品を患者さんにお届けするまでの広範な開発戦略について議論を行う。第一部：アジア試験における効果的かつ効率的なコミュニケーション座長： EPSインターナショナル株式会社早川智久第一三共株式会社宮崎浩一アジア試験の効率的な運用について ―スポンサーの立場から― 第一三共株式会社森元健介 Effective Communication in Regional Clinical Studies EPS International James Cheong 国内審査期間中に実施したロチゴチン・パッチのアジアにおけるPhase 3b試験大塚製薬株式会社池田純司 15:30-16:00 コーヒーブレイク 16:00-17:00 セッション3 （続き）第二部：各国の医療制度を踏まえた開発戦略座長： EPSインターナショナル株式会社早川智久第一三共株式会社宮崎浩一アジアにおけるエリブリンメシル酸塩の承認申請 ―韓国での承認申請について― エーザイ株式会社渡辺達夫中国の医療行政と医薬品市場の現状と今後の動向 CMJ Pharma 重村新吾 EPSインターナショナル株式会社早川智久第一三共株式会社宮崎浩一パネリスト：セッション3の全講演者 18:00-18:10 閉会の挨拶 18:10 カンファレンス終了会議参加申込書一般社団法人ディー・アイ・エー・ジャパン Fax:03-3583-1200　〒106-0041 東京都港区麻布台1-11-10 日総第22ビル7F Tel: 03-5575-2130 第8回DIAアジア新薬開発カンファレンス [カンファレンスID　#14302] 2014年5月22日～23日　｜ソラシティホール（御茶ノ水）〒101-0062 東京都千代田区神田駿河台４－６ ◆ 参加申込方法 DIAウェブサイト(www.diahome.org)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またはメール添付[email protected] にてお申し込みください。受理後、10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。会員資格はお支払いいただいてから翌年同月末まで１年間有効です。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、種々の特典も得られます。不明な点がございましたら、ディー・アイ・エー・ジャパンまでお問い合わせください。 ◆ 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。会員早期割引 2014年5月9日までのお申込み  \59,000 （税抜） \63,720 （税込）一般 2014年5月10日以降のお申込み政府関係／非営利団体／大学関係／医療従事者  \64,000 （税抜） \69,120 　請求書を希望します（税込）  \25,000 （税抜） \27,000 （税込） DIA Japan 使用欄非会員会員登録する＊登録費 \16,200 を含む Date 一般早期割引 2014年5月9日までのお申込み  \74,000 （税抜） \79,920 （税込） 2014年5月10日以降のお申込み  \79,000 （税抜） \85,320 （税込）政府関係／非営利団体／大学関係／医療従事者  \40,000（税抜） \43,200（税込）会員登録しない一般  \79,000 （税抜） \85,320 （税込）政府関係  \40,000（税抜） \43,200（税込） No. 受領書送付 Invoice 非営利団体／大学関係／医療従事者  \25,000 （税抜） \27,000 （税込）入金 ◆ お支払方法ご希望の支払方法にチェックを入れてください。 [支払方法] □銀行振込　みずほ銀行　神谷町支店　普通　1273382　（口座名義）一般社団法人ディー・アイ・エー・ジャパン □クレジットカード使用可能クレジットカード（どちらか1つにチェック）　□VISA □MasterCard カード有効期限(mm/yy) カード番号カードご名義ご署名ご入金の際は、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。同一会社で複数名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日をディー・アイ・エー・ジャパンまでお知らせください。振込に関する手数料は、振込人負担でお願いいたします。アルファベット(英語)でご記入ください Last Name ( 姓 ) Dr.  Mr.  Ms. First name ( 名 ) Company Job Title Address email ( 必須 ) Department City State Phone Number ( 必須 ) Zip/Postal Country Fax Number * 参加のキャンセルは、お申し込み受理後、2014年5月15日までは手数料として一般会員・非会員とも20,000円、政府/大学関係者については会員・非会員とも 10,000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。同一会社からの参加変更は可能ですが、その際はお早めにディー・アイ・エー・ジャパン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、必ず書面にてディー・アイ・エー・ジャパン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。