Interested in speaking? Apply Here!

Agenda

Asia-Pac - Day 1 | Monday, September 25, 2017
9:00
Registration and Continental Breakfast
9:30
Co-Chairpersons’ Opening Remarks
Yasuko Meguro, Senior Director, Clinical Quality Management Group, Development Function, DAIICHI SANKYO
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
9:45
Key Success Factors to Implement Your eTMF Strategy
  • Clarify your own business needs
  • Organize your eTMF project team; involve key stakeholder (not only clinical operation members)
  • Change mindset; eTMF system(s) makes TMF process responsibility clear
  • Implement eTMF system and schedule key processes
Tomoko Asakawa, Clinical System and Process Management Group in Clinical Operation Dept, CHUGAI PHARMACEUTICAL
Miki Someya, Clinical System and Process Management Group in Clinical Operation Department, CHUGAI PHARMACEUTICAL
10:30
Networking Break
11:00
CASE STUDY: Refine Your Approach to Implementing a TMF Process
  • Survey the TMF process from study start-up to archival on a paper-based platform
  • Evaluate how to digitize essential documents to better prepare for a potential eTMF strategy
  • Institute best practices for how to adapt your current approach to an electronic system
Ken Okutani, Quality Control Team, Clinical Development Department, Pharmaceutical Division, JAPAN TOBACCO
11:30
Implement Quality to Prevent Critical Findings
  • Enhance quality to assist in productive inspection
  • Hear strategies for regulatory feedback
  • Leverage your TMF process as an oversight tool to proactively identify inspection risks
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
12:30
Networking Lunch
13:45
PANEL: Discuss Strategies for Preparing for an eTMF System by Ensuring Internal Buy-In and Starting the Preparation Process
  • Recognize the impact of an eTMF process on all aspects of a clinical trial
  • Communicate the benefits to senior leadership by creating an impact analysis in order to gain internal buy-in
  • Understand how an eTMF system’s SOPs, QC process and technology will impact the sites, sponsors and CROs
  • Create an implementation plan based on the challenges and the sponsor’s concerns before implementation
  • Develop and execute a roll-out plan that will allow you to monitor and address the challenges that occur during the first 90 days
Moderator
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Panelists
TOMOKO ASAKAWA, Clinical System and Process Management Group in Clinical Operation Dept, CHUGAI PHARMACEUTICAL
TATSUSHI TSUDA, Director, Development Coordination Group, Drug Development Division, SUMITOMO DAINIPPON PHARMA
JAMIE TOTH, Head of TMF Operations, DAIICHI SANKYO
14:30
Networking Break
15:00
Develop a Plan for Migrating Your TMF Process
  • Define the scope and priority for the migration from a paper or legacy system, addressing factors including:
    • Project planning
    • Define metadata for migration
    • QC and validation approaches
Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY, a QUINTILESIMS COMPANY
15:45
Manage Your Trial Master File Effectively by Developing a TMF™ Structure and Execution Plan That Accounts for All Challenges and Solutions
  • Cover TMF plan basics, including terms, composition and regulatory expectations
  • Design a TMF management plan that incorporates all roles and responsibilities for CROs, sponsors and other stakeholders
  • Get an overview of the TMF process reference model
  • Learn how to roll out a TMF management plan in a life science organization
  • Make the TMF process accessible for the study team and health authorities
Saki Akihara, Process Control Manager, Clinical Operations, BAYER YAKUHIN
Sakiko Inamura, Clinical Quality Control / QC Expert, BAYER YAKUHIN
16:45
Conclusion of Day One
Asia-Pac - Day 2 | Tuesday, September 26, 2017
8:30
Registration and Continental Breakfast
9:15
Co-Chairpersons’ Recap of Day One
Yasuko Meguro, Senior Director, Clinical Quality Management Group, Development Function, DAIICHI SANKYO
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
9:30
An Update on the Implementation of an eTMF Process in Japan Using the FxG System
  • Hear updates on how an eTMF process in Japan is utilized to collect, monitor, manage and archive documents
  • Compare the impact of an eTMF plan versus that of the FxG system
  • Discuss best practices and lessons learned when dealing with implementation challenges
  • Recognize the impact of an eTMF process on study management teams
Keiko Watanabe, eTMF Implementation Lead, SUMITOMO DAINIPPON PHARMA
10:15
CASE STUDY: Simulate Using an eTMF Plan As a CRO to Improve the Quality of the TMF Process
  • Uncover issues when a CRO is using an eTMF plan managed by a sponsor
  • Explore the challenges of working with a CRO’s eTMF system
  • Ensure the efficacy of a universal QC method that will not be compromised by the persons conducting it
Aya Akimoto, Clinical Development, Quality Management, A2 HEALTHCARE CORPORATION
11:00
Networking Break
11:30
PANEL DISCUSSION: Improve TMF Quality for Paper-Based and Electronic TMF Plans Through a Healthy and Fitting CRO/Sponsor Relationship
  • Put a process in place before study start-up so the CRO and sponsor have clearly identified roles
  • Benchmark effective strategies to improve the governance of a CRO using data gathered through QC or metrics
  • Study the impact of stakeholder oversight and metrics when a TMF plan is owned by a sponsor versus a CRO
  • Compare and contrast the particular benefits of using the TMF process of a CRO versus the TMF process of a sponsor
Moderator
JAMIE TOTH, Head of TMF Operations, DAIICHI SANKYO
Panelists
AYA AKIMOTO, Clinical Development, Quality Management, A2 HEALTHCARE CORPORATION
ANGELA MAO, Associate Director, TMF Operations, INC RESEARCH
MIYUKI TAGUCHI, Senior eTMF Specialist, COVANCE
WENDY TRIMBOLI, Director, Head Of Global TMF Management and Compliance, EISAI
12:30
Networking Luncheon
13:30
TMF Process Quality Oversight – Metrics/Report Utilization and CRO Collaboration
  • Consider the benefits of TMF metrics/reports in an eTMF system
  • Outline best practices for improving TMF process quality and inspection readiness
  • Collaborate with CROs in the TMF process area
Kiyoko Matsushima, Clinical Development Quality Group, Study Performance Operations, PFIZER JAPAN
Toshie Yamamoto, Japan Clinical Development Quality, Study Performance Operations, Development Operations, Development Japan, PFIZER JAPAN
14:30
Networking Break
15:00
CASE STUDY: Case Study: Hear Eisai’s Experience and Process of Implementing eTMF in Japan
  • Compare and contrast the regional processes, adaptations and design of two eTMF operating models
  • Understand the differences in document collection and filing
  • Utilize the TMF Reference Model when developing a filing guide for Japan eTMF
  • Engage internal cross functional teams to design, plan and execute an eTMF
Wendy Trimboli, Head of TMF Process Management and QC, EISAI
15:45
CASE STUDY: Establish an eTMF System Management Process to Ensure TMF Process Quality
  • Leverage exemplars of TMF system management processes to illustrate the desired level of quality
  • Identify what kinds of QC methods are needed
  • Hear an overview of TMF management plan
Akiko Hirai, Associate Manager, Clinical Quality Management Group, Development Function, DAIICHI SANKYO
16:30
Co-Chairpersons’ Closing Remarks
Yasuko Meguro, Senior Director, Clinical Quality Management Group, Development Function, DAIICHI SANKYO
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
17:00
Summit Concludes

Download the Conference Brochure

Get all of the latest information for this TMF™ event! Download Now
live chat software