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Event Nameexl pharma 2017 2nd Asia-PAC Trial Master File Summit
Event Date(s) Monday, September 25, 2017  to Tuesday, September 26, 2017
Event Location The Westin Tokyo
Cost¥160,000 - ¥200,000
DescriptionA 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
Preparation for when regulatory authorities are asking for eTMF access
And much more!

Top Five Reasons to Attend

Explore best practices to develop or enhance a TMF management process
Understand how to best prepare for an inspection
Explore all the options of CRO oversight when using their eTMF
Learn how to implement or roll out an eTMF that will meet the needs of your organization and global regulatory authorities
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
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
SponsorRebound Therapeutics
Host CompanyRebound Therapeutics
Contact Information Phone: 866-207-6528
Fax:   888-221-6750 
More Information