A TMF is not only a living archive of a clinical trial 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 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.

Date : 25th September 2017 to 27th September 2017

Place : Japan, Tokyo

Website :https://www.eventbrite.com/e/2nd-asia-pac-trial-master-file-summit-exl-tickets-34262765855?aff=NDT

Contact Person:Paula Edwards

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.

A TMF is not only a living archive of a clinical trial 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 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. will be held in Tokyo,Japan on date 2017-09-27

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Deadline for abstracts/proposals : 7th September 2017

Keynote Speakers :

Conference Highlights :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

Venue :Meguro, Tōkyō-to 153-8580, Japan

Check the event website for more details.