ICH M2 EWG Work Plan 25 August 2014 Topic Adopted: 1994 Last Face-to-Face Meeting: Minneapolis, MN, USA – June 2014 The following roles and responsibilities of M2 were approved by the SC: 1) Provide overview of ICH and SDO technical standardization activities (past, current and future) 2) Provide a framework for a structured way of working 3) Manage relations (between projects and between organizations (EWG-EWG, EWG-SDO, ICH-SDO)) 4) Provide a maintenance structure 5) Establish and maintain an “Information Repository” for EWGs (e.g., working practices, best practice guides and templates) 6) Deliver consultative support to EWGs requiring technical specifications 7) Establish and maintain ICH Object Identifiers (OIDs) 1. Anticipated Milestones Completion Date Deliverable 30 June 2014 File format criteria document is finalized. 15 September 2014 Current state of redaction requirements & approaches for ICH regions are evaluated for discussion at Lisbon meeting. 15 2014 September DOCX use cases focused on whether DOCX can be used in a dossier are gathered and evaluated. 1 October 2014 Depending on the result of discussion, ESTRI recommendation on DOCX is drafted. 15 October 2014 A report to SC on external activities and their potential impact on closed and/or potential ICH topics is drafted. 2. Timelines Date Task / Activity Details 10 September 2014 SDO Relationship Management review SDO Relationship Management review in cooperation with the Secretariat 10 September 2014 TBD Finalize file format criteria Upload all final documents to Information Repository Finalize file format criteria document Upload all final documents to Information Repository on a shared site to be provided by the Secretariat Page 1 of 2 TBD Upload M2 working documents to internal site Upload M2 working documents to a shared internal site to be provided by the Secretariat 10 September 2014 Redaction requirements & approaches for ICH regions Evaluate “current state” of redaction requirements & approaches for ICH regions 10 September 2014 Draft M2 strategic framework Draft M2 strategic framework guiding principles and process 07 August 2014 Draft agenda for Lisbon Develop agenda for M2 meeting for Lisbon 15 September 2014 Gather and evaluate DOCX use cases 30 September 2014 30 September 2014 Review active & candidate EWG concept proposals SDO participation list Gather and evaluate DOCX use cases focused on whether DOCX can be used in a dossier; share information with all parties Review active & candidate EWG concept proposals, formulate initial assessments Update SDO participation list 30 September 2014 Updates from SDO monitors Required updates from SDO monitors 01 October 2014 Possible draft recommendation on DOCX Schedule discussions with active EWGs Draft an ESTRI recommendation on DOCX for review before Lisbon Schedule discussions with active EWGs where initial assessments indicate potential impacts 15 October 2014 Draft a report to SC on external activities 01 November 2014 Further evaluate structured content approaches 01 November 2014 Approaches for handling adoption of standards outside of ICH regions 01 November 2014 Information from authorities on accepting receipt of PDF/A SDO monitoring Review results Write report to SC on external activities and their potential impact on closed and/or potential ICH topics Further evaluate structured content approaches, ID regulatory activities in each region to compile portfolio and opportunities to harmonize Evaluate with Secretariat approaches for handling adoption of standards outside of ICH regions (determine steps to achieve a policy & process) Collect information from authorities on accepting receipt of PDF/A (informational) Review SDO monitoring results 15 October 2014 01 November 2014 Page 2 of 2