When: hh:mm , 30JAN2012
Attendance: Paul; Bhanu; Patricia; Carol Ann; David; Jonathan
- Who's here?
Thanks for joining us today
I am attaching a copy of the dataset (File:Working Group 2 Variables and Format (2).pdf) that was presented today.
The following are the three questions raised by Paul as potential topics:
1) Helps facilitate implementation of risk-based monitoring plan (building quality into your process--if you know the risk-attributes up-front, you can attempt to mitigate these specific issues at the outset)
2) Making FDA's risk attributes for CI sites more transparent
3) Expediting the FDA site inspection (i.e.-drafting inspection assignment; on-site inspection)
Some points raised in today’s discussion (please edit/amend)
1. Can we have greater visibility into the analysis tool?
2. How will a clear definition of the dataset impact the way sponsors prepare for site audit.
3. What are some of the current practices/analyses conducted internally by sponsors ?
4. What is the impact on internal process for creating the requested dataset on the overall process of preparing and NDA/BLA?
Please share potential topics areas with Paul/team by 3 Feb (core team)
Develop an outline agenda for the Meeting (Paul?)
Schedule discussion of agenda – week of 6 Feb.(M Brennan)
Extend the invitation to the prep work to others that have registered for the meeting.(M Brennan)
Please add any additional notes comments from today’s meeting
Last revision by SaschaAhrweiler,02/3/2012