DIA Japan Annual Program-English Version .....13 Program-Japanese Version ... network by enjoying the

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  • 9th DIA Japan Annual Meeting Importance of Development Strategies for Life Cycle Management of Safe and Eff ective Medical Products “What can we do from the start of development to benefi t patients?”

    November 19-21, 2012 Toshi Center Hotel | Tokyo, Japan

    Endorsement by MHLW, PMDA, and JPMA. 後援:厚生労働省/独立行政法人 医薬品医療機器総合機構/日本製薬工業協会

  • 2TABLE OF CONTENTS

    Program Committee ...................................... 6

    Time Table-English Version .......................... 8

    Time Table-Japanese Version .....................10

    Program-English Version ............................. 13

    Program-Japanese Version ........................ 35

    Exhibitor List And Floor Plan ..................... 59

    Exhibitor Summaries ...................................60

    Presenter’s Biographies ..............................64

    Floor Plan-Toshi Center Hotel .................... 69

    TABLE OF CONTENTS

  • 3

    On behalf of our global network of members and volunteers, thank you for registering to attend and welcome to our 9th DIA Japan Annual Meeting: Importance of Development Strategies for Life Cycle Management of Safe & Eff ective Medical Products – “What can we do from the start of development to benefi t patients?”

    In 1990, representatives of regulatory agencies and industry associations in Japan, the European Union and the US, stepped forward in Brussels to found the International Council on Harmonization (ICH) upon the premise that regulatory harmonization would directly benefi t world health, regulatory agencies and industry. A few years later, DIA presented our fi rst educational programs in Japan and in 1995 established our fi rst Japan offi ce. Over the past two decades, Japan’s active engagement in the ICH, the Asia Pacifi c Economic Cooperation (APEC) Life Sciences Innovation Forum, the APEC Harmonization Center (AHC) and the China-Japan-Korea Tripartite Initiative, all demonstrate Japan’s important leadership in promoting global drug development and regulatory sciences. As Japan’s scientifi c, technological and regulatory leadership continued to expand globally, DIA’s member and volunteer network in Japan commensurately grew; in 2005, DIA’s Advisory Council of Japan was elevated from provisional to full.

    The health care landscape in Japan and around the world has changed in every way imaginable – and in ways that might have been previously unimaginable – since these events. You will fi nd that your expert Program Committee has put together an Annual Meeting agenda that refl ects the most current and forward-looking scientifi c, industry, regulatory and other perspectives, and will help us shape and refi ne this landscape to the benefi t of patients all around the world.

    We off er our sincere thanks to all who served so well on this Committee, led by our Program Chairperson Kazunori Hirokawa, MD, PhD (Daiichi Sankyo Co. Ltd.) and Program Vice-chair Junichi Nishino (Novartis Pharma K.K.). In addition, we are very grateful for the service of Yoshiaki Uyama, PhD, from the Pharmaceuticals & Medical Devices Agency (PMDA) on this Committee.

    We thank our Keynote Chairs and Speakers, and look forward to the wisdom they will share from the podium: Dr. Tatsuo Kurokawa (Keio University); Dr. Peter Bachman, (Coordination Group for Mutual Recognition & Decentralised Procedures – Human); and Dr. Takao Yomori, also of the PMDA. We are also grateful to our volunteer Advisory Council of Japan, chaired by Dr. Kurokawa, and our DIA Japan staff , led by DIA Japan Director Ko Sekiguchi, for their continuous, valuable support.

    The scope of this meeting has expanded into a six-track, three-day workshop to allow for more discussion and for more topics – project management, for example – than previous Annual Meetings in Japan could accommodate. In addition, our 9th DIA Japan Annual Meeting is the fi rst to off er pre-conference tutorials, six sharply-focused and content-rich sessions on such essential topics as risk management plans, bioequivalence studies and guidelines, and what comprises the ideal skill set for clinical development professionals. These tutorials, plus the debut of the fi rst Student Sessions, mark grand steps forward for DIA’s Annual Meeting in Japan.

    For the next three days, our collaborative discussions will explore from numerous perspectives what we can do from the start of development to benefi t patients: How to balance quality and speed in clinical trials, communication between industry and regulatory agencies, multinational clinical trials, risk management regulations in Japan, the US and EU, and too many other topics to mention. In addition to patient benefi t, we also invite you to discover the benefi ts of participating in DIA’s global, multidisciplinary educational network by enjoying the DIA Volunteer Service Award presentation during our opening plenary session, and the cutting-edge products and services that our exhibitors will present to you.

    Thank you again for registering to attend, and welcome to Tokyo for our 9th DIA Japan Annual Meeting.

    LING SU, PhD PAUL POMERANTZ

    President DIA Worldwide Executive DIA Board of Directors Director

    PAUL POMERANTZ

    Worldwide Executive Director

    WELCOME NOTE

    LING SU, PhD

    President DIA Board of Directors

    9th DIA Japan Annual Meeting Importance of Development Strategies for Life Cycle Management of Safe and Eff ective Medical Products “What can we do from the start of development to benefi t patients?”

    “The scope of this meeting has expanded into a six-track, three-day workshop to allow for more discussion and for more topics – project management, for example – than previous Annual Meetings in Japan could accommodate.”

  • 4SCHEDULE AT-A-GLANCE

    11月19日(月) 8:30- チュートリアル受付   コスモスロビー (3F)

    9:30- 展示受付 コスモスロビー (3F)

    9:00-13:15 チュートリアル/ スチュー デントセッション

    12:00- 参加者受付 コスモスロビー (3F)

    12:00-18:00 展示会場オープン コスモス I (3F)

    13:30-14:00 開会の挨拶    コスモス II (3F)

    14:00-14:20 DIA AWARD 授賞式 コスモス II (3F)

    14:20-14:50 委員長講演    コスモス II (3F)

    14:50-15:20 コーヒーブレイク コスモス I (3F)

    15:20-16:20 基調講演1    コスモス II (3F)

    16:20-17:20 基調講演2    コスモス II (3F)

    18:00-19:30 情報交換会    ルポール麹町* *都市センターホテルから徒歩1分。ビルを一つ挟んだ並びにあります

    11月20日(火) 8:30- 受付    コスモスロビー (3F)

    9:00-20:00 展示会場オープン   コスモス I (3F)  

    9:00-10:30 セッション   

    10:30-11:00 コーヒーブレイク コスモス I (3F)

    11:00-12:30 セッション

    12:30-13:30 ランチブレイク*

    13:30-14:30 セッション

    14:30-14:45 ブレイク

    14:45-15:45 セッション

    15:45-16:15 コーヒーブレイク コスモス I (3F)

    16:15-17:45 セッション

    18:00-19:30 ミクサー コスモス I (3F)

    18:30-20:00 ダイバーシティフォーラム コスモス II (3F) *3階の展示会場(コスモス I )にコーヒーとスナックのご用意があります

    11月21日(水) 8:30- 受付 コスモスロビー (3F)

    9:00-15:30 展示会場オープン コスモス I (3F)

    9:00-10:30 セッション

    10:30-11:00 コーヒーブレイク コスモス I (3F)

    11:00-12:30 セッション

    12:30-13:30 ランチブレイク*

    13:30-15:00 ラウンドテーブル 1 コスモス II (3F)

    15:00-15:30 コーヒーブレイク コスモス I (3F)

    15:30-17:00 ラウンドテーブル 2 コスモス II (3F)

    17:00-17:15 閉会の挨拶 コスモス II (3F)

    17:15 終了

    *3階の展示会場(コスモス I )にコーヒーとスナックのご用意があります

    MONDAY, NOVEMBER 19 8:30- Registration for tutorial Cosmos Lobby(3F) 9:30- Exhibitor Registration Cosmos Lobby(3F)

    9:00-13:15 Tutorials & Student Sessions

    12:00- Attendee Registration Cosmos Lobby(3F)

    12:00-18:00 Exhibition Hall Open Cosmos I (3F)

    13:30-14:00 Welcome Cosmos II (3F)

    14:00-14:20 DIA Award Presentation Cosmos II (3F)

    14:20-14:50 Opening Remarks Cosmos II (3F)

    14:50-15:20 Coff ee Break

    15:20-16:20 Keynote Speech 1 Cosmos II (3F)

    16:20-17:20 Keynote Speech 2 Cosmos II (3F) 18:00-19:30 Reception Le Port Koujimachi* *Located in two buildings away at a distance of 1-min-walk from Toshi Center Hotel.

    TUESDAY, NOVEMBER 20 8:30- Registration Cosmos Lobby(3F)

    9:00-20:00 Exhibition Hall Open Cosmos I (3F)

    9:00-10:30 Sessions

    10:30-11:00 Coff ee Break Cosmos I (3F)

    11:00-12:30 Sessions

    12:30-13:30 Lunch Break*

    13:30-14:30 Sessions

    14:30-14:45 Short Break

    14:45-15:45 Sessions

    15:45-16:15 Coff ee Break