MnM Minutes CC 20120926

M&M Conference Call 4:00PM Eastern Time (Date above)

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Agenda

• Harmonization proposal from Wendy H.
• PSS from Kevin C.

Attendees

• Wendy Huang
• Austin Kreisler
• Lloyd McKenzie
• Jean Duteau
• Rob Hausam

Harmonization Proposal

Reviewed draft harmonization proposal posted to list by Wendy. Proposal is to update descriptions of 3 concept domains. Austin noted that one of the concept domains is deprecated. Not a reason to not improve the definition.

Motion: MnM endorses this proposal to go forward to harmonization. Move Wendy, second Austin: Unanimous

PSS Proposal

Kevin C. has asked MnM to endorse a PSS dealing with Detailed Clinical Models

Discussion:

• Committee found the text very long and confusing. The scope needs to be much more concise.
• At minimum, we have a concern about the proposal to create CMETs.
• Step 1 should indicate that the expected outcome is harmonization proposals
• We need clarity on exactly what MnM’s role will be and how DCM methodology is expected to be distinct from existing methodology for creation of v3 models.
• It also seems odd to have methodology covered last.
• We need more clarity in the proposal and then perhaps to hold a joint call before we could consider endorsing

Motion: Defer decision on endorsement until above issues are addressed. Austin/Jean: 3:0:1

Adjournment

Call adjourned at ~16:40