New York Professional Events List


Asia-Pac Trial Master File Summit


Date
Sep 25, 2017 - 07:00 AM - Sep 26, 05:00 PM
Link to Website
Organizer
tmfsummit
Location
The Westin Tokyo1-4-1 Mita Meguro-kuTokyo, Japan 153-8580,

Tokyo ,
Japan ,
US,
ZIP: 153-8580
Phone: +1 929 900 1853

Asia-Pac banner

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

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

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Please contact the event manager Marilyn below for the following:
 
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
 
Event Manager Contact:


marilyn.b.turner(at)nyeventslist.com or Contact:  +1 929 900 1853
 
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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This Event Listing is Promoted by  New York Media Technologies LLC in association
with EXL Events Inc.

 
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Agenda


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

Event Categories
BUSINESS & MANAGEMENT CONFERENCES
,
Technology
Keywords: fun, access , administration , Clinical , conference , design , developing, development , Eating, Fun




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