The PMDA and other regulatory authorities offer guidelines for how these documents should be stored and made available for an inspection. Your TMF is inspection-ready if it is complete, accurate and in accord with the guidelines of PMDA and other regulatory authorities.
Attending the 3rd Asia-PAC TMF Summit is critical if you want to be apprised of the latest guidelines, equipped with proven metrics and tools and prepared to work with internal allies from disparate functions as well as third-party providers. Participants will study the TMF Reference models and will be informed, equipped and poised to:
Avoid critical findings through mock inspections aligned with inspection trends
Minimize risk and inefficiencies by communicating responsibilities and expectations
Fortify quality through a defined structure and vigilant Quality Control
Adapt your data integrity strategy and SOPs when you use your eTMF or your CRO’s TMF
Customize KPIs and metrics to monitor outsourced functions
Participants of this will study the necessities of a coherent paper or electronic TMF system and learn to compose a comprehensive TMF management plan that assures fidelity and adherence to that plan.
"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 eTMF systems at the regional and global levels."
For more information regarding TMF Asia-Pac, please fill out the form.More Information