¥158,900 – ¥478,900

2nd Asia-PAC Trial Master File Summit (EXL)

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The Westin Tokyo

Meguro-ku, Tōkyō-to 153-8580

Japan

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Description

A TMF is not only a living archive of a clinical trial’s progress — it is a record required by regulatory authorities and is critical for clinical oversight. By developing, implementing and utilizing a TMF plan, you will be able to monitor a trial’s progress, ensure high-quality documents and be prepared for an inspection. Additionally, creating a TMF means that clinical trial sponsors, CROs and sites can demonstrate that they are meeting GCPs during trials, whether an inspection is conducted by the MHRA, EMA, PMDA or FDA.

At the 2nd Asia-PAC Trial Master File Summit, 15+ speakers will address:

  • Ways to increase quality by implementing QC
  • How to implement and utilize TMF metrics
  • Necessary documents to include in a TMF
  • Preparation strategies for an inspection
  • Methods for selecting when to use a CRO’s eTMF versus an internal system
  • How an eTMF system can increase quality
  • Training and staffing needs for a TMF
  • Methods for improving clinical operations in TMF management
  • TMF milestones and SOPs to ensure timely document submission
  • Preparation for when regulatory authorities are asking for eTMF access

And much more!

Top Five Reasons to Attend

  1. Explore best practices to develop or enhance a TMF management process
  2. Understand how to best prepare for an inspection
  3. Explore all the options of CRO oversight when using their eTMF
  4. Learn how to implement or roll out an eTMF that will meet the needs of your organization and global regulatory authorities
  5. Network with 75+ global trial master file professionals

Testimonials

"Great event to explore various phases that exist in an eTMF rollout in Japan."


"There is no other event this specifically tailored to TMF matters that we would go to."


"Very exciting summit, it is of great help to consider how the sponsor deals with eTMFs at the regional and global levels."


Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:

  • TMF and eTMF Management
  • Clinical Document/Data Management
  • Clinical Trial Administration
  • Clinical Operations
  • Regulatory Affairs/Operations
  • Trial, Document and Record Management
  • Clinical Document Coordination
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • Competency Development
  • Strategic Operations and Planning
  • Quality Management
  • Informatics
  • Clinical IT

This program will also be of interest to:

  • eTMF Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers

Key subject areas

Topics under consideration for this event include:

  • TMF management for global and local trials
  • TMF metrics for QMS
  • QC or QA development
  • eTMF implementation or rollout in Japan
  • Ways to work with a CRO to manage your eTMF
  • Methods for preparing for a PMDA inspection
  • TMF operational challenges
  • Best practices for destroying paper documents

Sponsors

Phlexglobal

Phlexglobal


Phlexglobal are the Trial Master File (TMF) experts, and pioneers in the provision of innovative, flexible and technology-enabled TMF solutions and services.

A specialist provider of electronic Trial Master File (eTMF) solutions and other support services to the global clinical research market, we offer a unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the life science industry.

Wingspan Technology, Inc.

Wingspan Technology, Inc.


Wingspan Technology, a QuintilesIMS company, provides an ECM platform for the life sciences industry in a high-performance, scalable, validated cloud environment. Our industry-leading eTMF is used by sponsors and CROs of all sizes to manage trials from planning through archival. Wingspan eTMF provides the transparency needed to understand TMF health and inspection readiness, along with tools to support and measure the productivity of eTMF processes. As a result, eTMF contributed significantly to supporting our clients’ record of successful health authority inspections.


Event Partners


FierceCRO

FierceCRO

Biopharma executives read FierceCRO to stay current on developments on clinical trials outsourcing, strategic partnerships between CROs and drug developers, lab services outsourcing and more. Sign up for our free weekly email newsletter to make sure you’re not missing out!

FiercePharma Asia

FiercePharma Asia


MEDtube.net

MEDtube.net

MEDtube is an innovative video education platform for health professionals. It allows sharing videos and other materials with a community of more than 110,000 users worldwide, as well as building e-learning courses. The videoteque is updated daily and now contains almost 15 thousand videos.

Pharmaphorum

Pharmaphorum

Pharmaphorum is the exciting new online discussion and networking site for the pharma, medical devices and diagnostics industry. It features topical articles by industry thought leaders upon which users can comment, a live forum for open discussion across various commercial and R&D areas, and a directory of conferences and companies. Aimed at those working in the industry or associated services sector, pharmaphorum welcomes all those involved in bringing healthcare to market who wish to share opinions and ideas in order to drive innovation and progression. Visit pharmaphorum today to share, discuss and debate.

PharmaVoice

PharmaVoice

PharmaVOICE magazine reaches more than 41,000 qualified subscribers and 100,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.

PM360

PM360

PM360 is the premier, must-read magazine for marketing decision-makers in the pharmaceutical, biotech and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal's targeted and insightful editorial focuses on issues that directly impact critical decision-making, including the planning and implementation of cutting-edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR and leadership. Additionally, the "360" in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Technology Networks

Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.



Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Date and Time

Location

The Westin Tokyo

Meguro-ku, Tōkyō-to 153-8580

Japan

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