1. www.diahome.org 1 Brett Claffee 11-Mar-2011 Paper Destruction - Legal Topic Team Agenda 2011-03-11

2. www.diahome.org Agenda Introduction (2 min) –Eldin Rammell –Lost Lucy Old Business (8 min) –Topic Team Logistics –Issues & Actions – review log New Business (40 min) –Understanding our scope/ Charter build out –Sub Team Updates AOB & Next Steps (10 min) Participants Member NamePresent? Brett ClaffeeX Eldin Rammell Mary Durham Maryanne Quinn Thomas DeNaro Yohan Benizri 2

3. www.diahome.org Old Business – Use for reference only How we want to work –Review of informal data, ideas, references – where to store; how to manage –Agree how to collect, review & approve citations – may come from sub team – we will deliver what we think the relevant references are – if there is a disconnect – ok – can be deleted when we are finished – Brett to generate DRAFT & APPROVED folders –Split group for each key deliverable, e.g IP? Share Meeting Minutes from Destruction Sub Team & New Folder Location & Proposed Plans – next slide 3

4. www.diahome.org Our Understanding From Destruction Sub Team 1.Definitions of rules of evidence for the destruction of paper copies of electronic versions, e.g. images, that are declared the original version 2.Definitions of rules of evidence for patent defensibility – might need more information – Brett to get back to Lisa to confirm What do we want to get out of this team? 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 4 New Business See 1 st tab for listing deliverables & 2 nd ? Tab for references

5. www.diahome.org New Business Format Review proposed workflow for deliverables Review citations/ references –How do we want to classify/ qualify these? Rate 0-5? Classify based on applicable region?, e.g. US Only, EU Only, US/ EU, Global, Other Review proposed eRecords position paper 5

6. www.diahome.org Sponsor – Who? DIA DRM SIAC Lisa Mulcahy – Destruction Sub Team Team – Who? Brett Claffee (TTL) Yohan Benizri Thomas DeNaro Eldin Rammell Mary Durham Maryanne Quinn Audrey Chenesseau 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? 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 See spreadsheet & incorporate here 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 Scope – What? NB (cont): Charter Build Out 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. Approach – How?

7. www.diahome.org AOB & Next Steps 1.Agree informal Charter 2.Agree how to collect, review & approve citations – may come from sub team 3.Offline (homework) – begin to list out potential sources; brainstorm ideas 7

8. www.diahome.org BACK UP SLIDES FOR REFERENCE 8

9. www.diahome.org Introductions Team Member Yohan Benizri Thomas DeNaro Mary Durham Maryanne Quinn Brett Claffee Eldin Rammell Audrey Chenesseau Factoids 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 BD, working on implementation of TMF system; how long to keep paper documents – corporate clin ops specialist – Lucy to send note to Lisa re: Participation on this team – welcome! 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 Freelance RM consultant – Pharma/ Biotech; 7- 10yrs; Director RM in Pfizer Clinical Space, prior Glaxo Associate in Sidely Austin, FDA practice; also representing Pfizer 9

10. www.diahome.org 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 e-mail –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, 2011-02-25 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 10

11. www.diahome.org Update from TTL Meeting Scope limited to North America & Europe Legal Topic Team now including patent defensibility Review of the Sub Team charterSub Team charter 11