1. Paper Destruction - Legal Topic Team
Kick-off Meeting
Attendees:
Tom Denaro
Mary Durham
Yohan Benizri
Lucy Fiore (BD)
Maryanne Quinn
Brett Claffee
Apologies:
Eldin Rammell
Brett Claffee
25-Feb-2011

2. Agenda Introductions (10 min) Topic Team Logistics (10 min)
Our Understanding of the Legal Topic Team Scope (20 min)
Update from the Sub Team TTL Meeting (10 min)
Informal Charter Build Out (5 mins)
AOB (5 mins)

3. Introductions Team Member Factoids Yohan Benizri Thomas Denaro
Mary Durham
Maryanne Quinn
Brett Claffee
Eldin Rammell
Audrey Chenesseau
Rebecca Allen
Sidley Austin, Belgium, representing Pfizer
‘Tom’ BD Assoc Clin Ops – met w/ team last week
Biogen Idec Sr Manager RM group – working w/ R&D; librarian, regulated RM
Integrated Submission Strategies – Operations & Submissions; worked for Merck – supporting Clinical & Regulatory – TMF documentation; eRecords vs Paper
Consultant for IM company; working for AZ in Archives & Records Management; previously did public service RM work; Worked for GSK for >10 years in labs and in R&D Document Management
Apologies from Eldin – pick up at next meeting
Associate at Sidley – Belgium office – Legal & Regulatory topic team pm behalf of Pfizer
Global Records Management services Pfizer. Reg focus includes clinical document set; customer support for business; redesigning trial master file process.

4. Legal Topic Team Logistics
Regular Meeting Times
Meeting Expectations
Scribe – Lucy will be our first scribe. Maryanne to send potential minutes templates.
Online vs. offline attendance – agreed to get comments & thoughts PRE meeting
Quorum – people at the meeting – Make sure you come if you have strong feelings about a key issue!; Decisions made at the meeting
Links be sent by
Brett to request from Lisa separate folder(s) for the topic teams in Connex site under Paper Destruction.
Team agreed to use the file location on connex to manage information, minutes, deliverables
How we want to work
Split group for each key deliverable, e.g IP? – Need to come back to this at next meeting
Documentation – how formal? – presentation of what others see should be professional looking – headers and so forth; don’t use connex as dumping ground – maybe discuss at meeting and decide how to capture, review & approve – be judicious – use dates in title – use dates as version control – YYYYMMDD, DRAFT Meeting Minutes
Collection of citations & references – is there a standard anyone uses, prefers? – Is there a DIA format? Brett to ask Lisa - agreed; Standard format for publications (APA, MLA) – check with Lisa & Ivan.
Expectation of reviews & approvals – agreed to be based on who attends meetings
What I can do

5. Our Understanding From Destruction Sub Team
What do we want to get out of this team?
Definitions of rules of evidence for the destruction of paper copies of electronic versions, e.g. images, that are declared the original version
Definitions of rules of evidence for patent defensibility
What does certification; declaration mean? Metadata approval (stamp); documentation for the process appropriate for rules of evidence – NA & EU; document itself is evidence - process of ensuring should be in PnPs – need both the ‘cerificate’ and process for generating the ‘cert’. – risk based approach? What does the certificate mean, say, include sign offs? Other? What does signature include – QC checked – FDA has definition of certified copy – Brett to ask Lisa for this doc.
To be covered at next meeting

6. Update from TTL Meeting - Did not review - send out charter for review
Scope limited to North America & Europe
Legal Topic Team now including patent defensibility
Review of the Sub Team charter

7. Charter Build Out - did not review
Sponsor – Who?
Sub Team Deliverables
[Legal] definition of ‘original’
Develop a framework, ready for broad public and health authority review.
The framework will be based in fact and will contain a robust bibliography
Based on further public feedback and expansion of the scope to other regions of the world, revision of the framework may or may not be required
Team – Who?
Brett Claffee (TTL)
Yohan Benizri
Thomas Denaro
Eldin Rammell
Mary Durham
Maryanne Quinn
DIA DRM SIAC
Lisa Mulcahy – Destruction Sub Team
Key Stakeholders – Who?
Pharmaceutical Industry – Clinical
Agencies and other defining bodies who could either be contributors or stakeholders in standard TMF documentation
Public organizations
Resource Requirements
Objectives – What?
Scope – What?
Approach – How?
Dates and Deliverables – When?
Week of 28-feb-2011 – TT Meetings Start
Legal portion of framework for VoC – June 2011
Review completed by Sep 2011
Revisions completed by end Nov 2011
Presentations of the framework Dec--Feb
Risks/ Opportunities - Why
Why are we doing this?
The process for the destruction of the paper document is complicated and requires a thorough examination of the requirements that confirm the electronic version is an exact duplicate of the paper that was scanned.

8. AOB & Next Steps - did not review
Agree informal Charter
Agree how to collect, review & approve citations – may come from sub team
Offline (homework) – begin to list out potential sources; brainstorm ideas