“治験デザインから紙版または電子版ベースでの保管まで十分に定義されたTMFプランを通してGCP、品質、および査察準備を十分に行う”
“治験デザインから紙版または電子版ベースでの保管まで十分に定義されたTMFプランを通してGCP、品質、および査察準備を十分に行う”
AsiaNet 69981
東京、2011年9月12日 /PRNewswire/ -- 第2回アジア太平洋地域治験マスターファイルサミット (https://goo.gl/rKTxyW )が9月25日・26日にかけて東京ウェスティンホテルにて開催されます。本サミットでは、治験マスターファイル(TMF)の構造を明確に定義することを通じて、皆様の治験業務における医薬品の臨床試験の実施の基準(GCP)適合性の向上、品質向上、および査察準備をサポートします。
TMFには、規制当局による治験のGCP適合性の審査に必要な、生きた記録としての役割だけではなく、皆様の治験業務の進捗を確認し、記録を保存し、品質を確保するという役割もあります。
以下は本年のサミットの主な議題です。
-- あらゆる問題点や解決策を考慮した、TMFの構造を作り実行計画を立てること
により、治験マスターファイルを効果的に管理する
-- TMFプロセスを実施するアプローチを洗練する
-- 査察の背景および実施について説明する
-- TMFの移行計画を立てる
-- eTMFを実施する際の臨床的効率を最大限に高める
-- FxGシステムを用いた日本におけるeTMFの実施に関する最新情報
講師紹介。
-- Saki Akihara, Process Control Manager, Clinical Operations, BAYER YAKUHIN
-- Aya Akimoto, Clinical Development, Quality Management, A2 HEALTHCARE
CORPORATION
-- Tomoko Asakawa, Clinical System and Process Management Group in Clinical Operation
Dept, CHUGAI PHARMACEUTICAL
-- Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY
-- Akiko Hirai, Associate Manager, Clinical Quality Management Group, Development
Function, DAIICHI SANKYO
-- Sakiko Inamura, Clinical Quality Control / QC Expert, BAYER YAKUHIN
-- Kiyoko Matsushima, Clinical Development Quality Group, Study Performance
Operations, PFIZER JAPAN
-- Yasuko Meguro, Senior Director, Clinical Quality Management Group, Development
Function, DAIICHI SANKYO
-- Ken Okutani, Quality Control Team, Clinical Development Department, Pharmaceutical
Division, JAPAN TOBACCO
-- Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
-- Miki Someya, Clinical System and Process Management Group in Clinical Operation
Department, CHUGAI PHARMACEUTICAL
-- Miyuki Taguchi, Senior eTMF Specialist, COVANCE
-- Jamie Marie Toth, Head of TMF Operations, DAIICHI SANKYO
-- Wendy Trimboli, Head of TMF Process Management and QC, EISAI
-- Tatsushi Tsuda, Director, Development Coordination Group, Drug Development
Division, SUMITOMO DAINIPPON PHARMA
-- Keiko Watanabe, eTMF Implementation Lead, SUMITOMO DAINIPPON PHARMA
-- Toshie Yamamoto, Japan Clinical Development Quality, Study Performance Operations,
Development Operations, Development Japan, PFIZER JAPAN
アジェンダ完全版はこちらをクリックするとパンフレットをご覧いただけます:
本日登録して、業界仲間と共有の課題について議論や協力に参加しませんか。チェックアウトの際は優先コードC850PR をお忘れなく: https://goo.gl/1CkQLL
For More information contact: ExL Events
Phone: +1 212-400-6240
Email: registration@exlevents.com
(日本語リリース:クライアント提供)
Increase GCP, Quality and Inspection Readiness Through a Well-Defined TMF Plan From Trial Design to Archival for Paper or Electronic Filings
PR69981
TOKYO, Sept. 12, 2017 /PRNewswire=KYODO JBN/ --
ExL Events' 2nd Asia-PAC Trial Master File Summit (https://goo.gl/5f4yhb )is
taking place September 25–26 at the Westin Tokyo. This event, the standard
bearer for all things TMF, will guide you and your team to improve GCP, quality
and inspection readiness through a well-defined TMF structure.
As a living archive of a clinical trial's progress, the TMF is an essential
tool that regulators use to determine whether or not you are GCP compliant.
Moreover, it is a critical function to monitor progress and filing, and to
ensure the quality of your trial.
Featured topics in this year's program include:
-- Manage Your Trial Master File Effectively by Developing a TMF
Structure and Execution Plan That Accounts for All Challenges and
Solutions
-- Refine Your Approach to Implementing a TMF Process
-- Walk Through the Background and Execution of an Inspection
-- Develop a Plan for Migrating Your TMF
-- Maximize Clinical Efficiencies When Implementing an eTMF
-- Receive an Update on the Implementation of eTMF in Japan Using the FxG
System
Meet the Speakers:
-- Saki Akihara, Process Control Manager, Clinical Operations, BAYER
YAKUHIN
-- Aya Akimoto, Clinical Development, Quality Management, A2 HEALTHCARE
CORPORATION
-- Tomoko Asakawa, Clinical System and Process Management Group in
Clinical Operation Dept, CHUGAI PHARMACEUTICAL
-- Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY
-- Akiko Hirai, Associate Manager, Clinical Quality Management Group,
Development Function, DAIICHI SANKYO
-- Sakiko Inamura, Clinical Quality Control / QC Expert, BAYER YAKUHIN
-- Kiyoko Matsushima, Clinical Development Quality Group, Study
Performance Operations, PFIZER JAPAN
-- Yasuko Meguro, Senior Director, Clinical Quality Management Group,
Development Function, DAIICHI SANKYO
-- Ken Okutani, Quality Control Team, Clinical Development Department,
Pharmaceutical Division, JAPAN TOBACCO
-- Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
-- Miki Someya, Clinical System and Process Management Group in Clinical
Operation Department, CHUGAI PHARMACEUTICAL
-- Miyuki Taguchi, Senior eTMF Specialist, COVANCE
-- Jamie Marie Toth, Head of TMF Operations, DAIICHI SANKYO
-- Wendy Trimboli, Head of TMF Process Management and QC, EISAI
-- Tatsushi Tsuda, Director, Development Coordination Group, Drug
Development Division, SUMITOMO DAINIPPON PHARMA
-- Keiko Watanabe, eTMF Implementation Lead, SUMITOMO DAINIPPON PHARMA
-- Toshie Yamamoto, Japan Clinical Development Quality, Study Performance
Operations, Development Operations, Development Japan, PFIZER JAPAN
To see the full agenda, click here to view the brochure: https://goo.gl/1n22YF
Register here and join your peers in collaborating and discussing common
industry challenges. Be sure to mention Priority Code C850PR when checking out:
For More information contact:
ExL Events
Phone: +1-212-400-6240
Email: registration@exlevents.com
SOURCE: ExL Events
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