WG2 30JAN2012

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When: hh:mm , 30JAN2012
Place: TC
Facilitator: Michael
Attendance: Paul; Bhanu; Patricia; Carol Ann; David; Jonathan


Who's here?

General discussion


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?

Next steps

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



Follow up

Last revision by SaschaAhrweiler,02/3/2012