IDMP Update for Bayer 22nd March 2017

Agenda Current status of EMA IDMP Implementation Navitas IDMP Readiness Maturity Assessment

Latest Suggested timelines from EMA - NCAs and Industry involvement throughout SPOR 2017 2018 PMS & SMS phase 1 external go-live RMS & OMS 2019… 2016 SPOR Programme participation & Engagement via SPOR Change Liaisons Analyse / adapt process to keep data synchronised Analyse / adapt systems to support process changes RMS mapping Post go live Industry should map against new Referential Lists Synchronise local data with SPOR OMS product comparison Key SPOR milestones NCAs activities Industry activities OMS mapping Request new/updated data prior to regulatory submission XEVMPD integration with RMS & OMS (*) eAF integration with OMS (*) CESSP (MAA) integration with RMS & OMS (*) (*) – subject to XEVMPD, eAF, CESSP planning Activities throughout SPOR PMS & SMS integration with Art 57 3

RMS & OMS delayed will go live by May 2017, More CVs would be included than originally planned Dosage Forms* Packaging (Containers) Routes of Administration Units of Measurement* Units of Presentation* EU Reg Authorisation Procedure Application Legal Basis Eligibility for Centralised Procedure EU Territorial Authority Ingredient role* Legal status of supply Manufacturing activity Shelf Life Type Special precaution for storage Variation Classification RMS @ Golive will contain All CVs from EDQM All CVs from XEVMPD All CVs from EUTCT New CVs from OMS Materials CV for IDMP Additional CVs added in the run up to PMS go live OMS @ Golive will contain: MAHs data come from XEVMPD MA Applicant Max Residual Level Applicant (Veterinary) Manufacturers to be added throughout the year 2017 OMS MAH (exists) MA Applicants MA Applicants* MRL Applicants* Note: List already in xEVMPD, mapping applicable to V only Mapping applicable to H only List not yet in xEVMPD , mapping applicable to H&V * List expected to change, mapping only after RMS Go-Live, see next slide

RMS and OMS proposed activities beyond 2017 Product/Application Lists II Product category Product Information document type Application Reference Reason Application Submission Type Applicants Submission Unit Type eCTD EU Context of Use Regulating Authority's Submission Unit Type Submission Mode Contact Party Role Source material species etc OMS 2018 Manufacturers 2019 MAH MA Applicants* MRL Applicants* Note: List already in xEVMPD, mapping applicable to V only List not yet in xEVMPD , mapping applicable to H&V * List expected to change, mapping only after RMS Go-Live, see next slide

EMAs suggested activities for the industry in 2017

What does the IDMP Program looks like with EMA suggested activities Topics IDMP Data Assessment Identify and agree IDMP attribute golden (authoritative) sources Agree on ownership of IDMP golden sources  1 Define Data Mapping Approach (CV) Determine your initial data mapping approach based on: location, type, volume, quality and stability Data Mapping starting with container and packaging RMS Goes Live ~ May 2017 2 Gap Analysis and Mapping Accessing EMA Referentials data Mapping/Matching Referentials data Resolving the Mapping Mismatches 3 Transform & enrich The mapping process should highlight any structural differences between your local source data and EMA data The mapping exercise enables identification of new/updated terms and preparation for data synchronisation. 4 Submit changes/upda tes Submit proposed updates and new items via a change request to EMA Update your local source data in line with the outcomes of these change requests 5 Ongoing Sync (long term approach) How to maintain data synchronicity on an ongoing basis post go-live of OMS and RMS (eg. Manual vs automated; continuous vs periodic batches). Gain a more complete view of the processes and systems that are impacted by SPOR and shift focus to prepare for PMS and SMS Final Implementation Guide ~ May 2018

PMS activity plan PMS key Dates Implementation Guidance Publication - Q2 2018 Go Live will be 12 months after publication – Q2 2019 Mandatory use of Article 57 (enforced) – Q4 2019 June 2017 – EMA needs to define the project (above timelines) and approve budgets May 2017 Finalization of Iteration 1 fields Fields increased to 112 Adjusted to ISO model Medicinal Product classification (6/7 fields) Support new business case – Variations Existing Business case – PV

Navitas IDMP Readiness Maturity Assessment

Background Based on the assessments we have carried out we have created a maturity assessment that looks at a number of criteria any organisation needs to have in place to be in a position to implement IDMP The assessment represents our thoughts. However, we would like to engage your support in ensuring the assessment is fit for purpose The assessment considers maturity across five criteria: Data management Process Governance Organisational capability (Change Management) Technology

Thoughtful Proactive Integration The X axis considers five levels of Maturity Systems and processes are fully integrated and managed through corporate level initiatives Optimised Process Driven There are systems and process integrated across the organisation Tactical Integration Systems and activities are integrated across the organisation based on process needs Activities are initiated and integrated as required by external stimuli Siloed Activities are functionally driven with little or no organisational oversight

Example of Data Management Assessment Siloed Tactical Integration Process Driven Optimised Thoughtful proactive integration Control Data control is governed by local SOPs Key data are managed by a central function e.g. Regulatory to meet a particular need There are global SOP at the process level controlling data Data is controlled through global SOP Data is fully controlled across the entire enterprise via globally approved SOPs Access Data is available within departments/divisions but difficult to access from outside a particular function Data access is granted on an as needed basis the onus is on the requesting function to find the data Data is available to specified people/roles to support specific processes e.g. XEVMPD Data is available to all accessed from Controlled vocabularies and controlled lists Data is available to all accessed from a fully integrated enterprise wide MDM System System integration Data is stored in local databases with minimal sharing Some data is stored centrally to meet specific requests. There may be some duplication with local databases There are centrally managed databases used to support business critical processes There is some integaration across critical systems Internal systems are fully integrated with external data sources Ownership There is little or no formal ownership agreed for specific data Ownership for some data elements is maintained centrally to meet a particular need Some data is owned by process owners but there is no co-ordinated standard approach to data ownership There is data ownership in the business but it still requires some formalisation Data ownership is clear and unambiguous with different parts of the business being stewards for specific data on behalf of the enterprise Sharing There is little or no data sharing across functions (this will mainly be due to a lack of knowledge rather than data hoarding) Some sharing of specific data happens on request Data is shared specifically to support specific processes Data is shared across the enterprise but this still requires further formalisation Data is freely shared across the enterprise Sources Data is accessed from multiple sources and there is little or no management of consistency There are some centralised data sources but these may not be integrated There are data sources specifically set up to support specified processes. However they may not be integrated or consistent with other source systems Data sources have been identified but there is still variability of quality across the sources Data sources are consistent and unambiguous Metadata There is little or no metadata associated with data making searching and finding data difficult Some metadata is stored alongside key data to enable searching Metadata required to support specified processes are captured Metadata are identified and captured for business critical data Data is easily identifiable with consistent metadata

Q&A

Gary Aldam gary. Aldam@navitas Gary Aldam gary.Aldam@navitas.net phone +44 (0)2392 268133    mobile +44 (0)7392 080390     fax +44 (0) 2392 268160     web www.navitas.net