1. IDMP Update for Bayer
22nd March 2017

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

3. 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

4. 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
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
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

5. 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

6. EMAs suggested activities for the industry in 2017

7. 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

8. 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

9. Navitas IDMP Readiness Maturity Assessment

10. 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

11. 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

12. 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

13. Q&A

15. Gary Aldam gary. Aldam@navitas
Gary Aldam phone +44 (0)     mobile +44 (0)      fax +44 (0)      web