0. 06 May 2018
On-boarding webinar Industry Change Liaisons 21st July 2016, 9:30–12:30 GMT
SPOR data services: Delivering quality data services on Substances, Products, Organisations and Referentials to power EU regulatory activities

1. Agenda Welcome Introduction to SPOR
Introduction to Industry Change Liaisons
Industry Change Liaison engagement approach
Your role as Industry Change Liaison
Next steps
Industry Change Liaisons kick-off webinar

2. Objectives of webinar
To ensure all Industry Change Liaisons share a base understanding of SPOR to be able to speak confidently about it with their colleagues
To build our change network: meet each other and understand other key contacts relating to the Programme
To ensure Industry Change Liaisons understand their role, key activities and next steps
To share the engagement approach and timeline and provide an opportunity to feed back
To provide an opportunity to share knowledge, best practice and ask questions
Industry Change Liaisons kick-off webinar

3. Welcome and introduction
EMA Francisco Penaranda - Head of Business Data Department and SPOR Programme Manager Isabel Chicharo - Deputy SPOR Programme Manager Marie-Helene Pinheiro - Industry stakeholder liaison Constantinos Ziogas - SME stakeholder office Angela-Christina Schmidt - SME stakeholder office Jos Olaerts - Veterinary Division Bernadett Stoddart - Veterinary Division Agnieszka Laka - SPOR Change team Alice Woodbridge - SPOR Change team Mayura Chawdhary - SPOR Change team
Industry Associations
AESGP
Medicines for Europe
EFPIA
EuropaBio
ECI-EEIG
Vaccines Europe
EUCOPE
EBE
EGGVP
IFAH Europe
EFSPI
Vendors/Experts
Marr Consultancy Ltd
Terminologeeze Ltd
Gematik
Reed Tech
CSC Life Sciences Business Process Services
LORENZ Life Sciences Group
Life Science Advisory
PAREXEL International
DACON Datenbank Consulting GmbH
Aris Global
Royal Botanic Gardens, Kew
GS1 Global Office
Industry Change Liaisons kick-off webinar

4. 06 May 2018
Introduction to SPOR

5. Motivation for ISO IDMP
06 May 2018
Motivation for ISO IDMP
“The use of internationally agreed terminology, format and standards should facilitate the interoperability of systems used for the performance of pharmacovigilance activities and avoids the duplication of encoding activities concerning the same information. It should also allow for an easier information exchange between regulatory authorities on an international level”
Commission Implementing Regulation (EU) No 520/2012
The ISO IDMP standards establish definitions and concepts and describe data elements and their structural relationships that are required for the unique identification of:
Medicinal product information (MPID/PCID) - ISO 11615
Pharmaceutical product information (PhPID) - ISO 11616
Substances (Substance ID/Specified Substance ID) - ISO 11238
Pharmaceutical dose forms, units of presentation, routes of administration and packaging - ISO 11239
Units of measurement (UCUM) - ISO
ISO IDMP standards apply to both authorised and investigational medicinal products for Human use
Industry Change Liaisons kick-off webinar

6. Lack of standardisation…
06 May 2018
The issue: lack of standardisation
Lack of standardisation…
Results in…
Different controlled vocabularies* are used across different NCAs
Names used for organisations differ between, and sometimes across different departments within, NCAs
Different names for products and substances are used across different NCAs
Data is often entered manually
Inconsistent data quality and duplication
Inefficiencies relating to correcting data and investigating data discrepancies
Manual intervention required to resolve data issues
Slower decision-making
Decision-making based on inaccurate information
*Controlled vocabularies (aka Referentials) are lists of terms that refer to attributes of medicinal and pharmaceutical products eg. dosage form, route of administration, unit of measurement
Industry Change Liaisons kick-off webinar

7. Regulatory activities
06 May 2018
Why do we need standardisation?
Standardised data will…
…improve signal detection and speed of response for authorised products, thus helping to save lives. Medicines save lives but can cause side effects; 5% of all hospital admissions and c.200,000 deaths per year in the EU are associated with adverse effects*
…allow substances and products to be described accurately enabling faster identification and withdrawal
…improve the link between the Supply Chain and the regulatory dossier since inspectors will have better records available to support their findings on Manufacturing sites
…allow substances and products to be described accurately enabling faster response to address shortages
…facilitate process efficiencies in regulatory activities e.g. submission of application forms and Variations
…enable prescriptions to use standardised data to describe medicines thereby enabling patients to obtain the right products when outside their home country
…help determine the authenticity of a medicine
Pharmacovigilance
Batch recalls
Falsified medicines
Shortages
ePrescription
Inspections
Regulatory activities
* Source: EC Press Release Data Base
Industry Change Liaisons kick-off webinar

8. The 5 new ISO IDMP standards are all about master data
06 May 2018
Implementing ISO IDMP through SPOR (1 of 2)
The 5 new ISO IDMP standards are all about master data
In the case of the regulated EU pharmaceutical industry, there are four domains of master data:
Master data is any information that is considered to play a key role in the core operation of a business and re-used for multiple purposes 1
Substances: Data that describes the ingredients that make up the medicinal product
Products: Data that describes the marketing authorisation, packaging and medicinal information relating to a product
Organisations: Organisations data that comprises of organisation name and location address data for organisations such as MAH, sponsors, regulatory authority, manufacturers
Referentials: Lists of terms (controlled vocabularies) used to describe attributes of products e.g. lists of dosage forms, units of measurement, routes of administration 2 3 4
Industry Change Liaisons kick-off webinar

9. Implementing ISO IDMP through SPOR (2 of 2)
06 May 2018
Implementing ISO IDMP through SPOR (2 of 2)
Four projects have been established to implement services that centralise management of each of the domains of master data
The four projects are collectively known as SPOR data services
The implementation of the four SPOR projects will be phased
SPOR applies to both domains, Human and Veterinary
In parallel, EMA is implementing the messaging standards developed by Health Level Seven (HL7), which define a format for the electronic exchange of data that is compliant with the ISO IDMP technical specifications.
Substance Management Services (SMS)
Product Management Services (PMS)
Organisations Management Services (OMS)
Referentials Management Services
(RMS)
Industry Change Liaisons kick-off webinar

10. Use of SPOR in regulatory activities
Use of SPOR in regulatory activities
Adoption of SPOR operating models will facilitate the implementation of consistent, centrally-maintained, ISO IDMP-compliant SPOR data, which will feed regulatory activity across the product lifecycle
Product
lifecycle
Investigational
(Pre-submission)
Authorisation
(Submission)
Post-authorisation
Use cases i.e. Regulatory activity dependent on SPOR data
Clinical Trials Applications
(as-is via Eudra CT;
to-be via CT Portal)
Marketing Authorisation Applications
(as-is via eAF;
to-be via CESSP – H&V) CP
DCP
MRP
National
Referrals
Pharmacovigilance
(as-is via eSubmission Gateway & web client; to-be - tbc)
PSUR
ICSR
ADR
Maintenance of Art 57
Future EC initiatives that will depend on SPOR data
eHealth
Falsified Medicines
PA Applications
& Referrals
(as-is via eAF;
to-be via CESSP)
Implementation of ISO IDMP standards is a legal obligation
The SPOR projects are the vehicle for implementing the ISO IDMP standards. They are also one of the critical enablers for achieving the Telematics vision and associated benefits
Benefits linked to SPOR will only be fully realised once all iterations have been implemented and once Member States & Telematics programmes dependent on SPOR data have fully integrated with the new systems and processes
Standardised data needs to be accessible at a global level so it can be re-used by Member States and other Programmes. However, standardised data alone is not sufficient. Standardised data becomes an enabler once integrated with other SPOR- dependent Programmes
Inspections (via Eudra GMDP integrated with SPOR)
Load inspection data onto Eudra GMDP
Master Data Management (Substance, Product, Organisation, Referentials) 10
Industry Change Liaisons kick-off webinar

11. Benefits of implementing SPOR
Standardised data alone is not sufficient to achieve benefits. The benefits of SPOR will be realised incrementally:
As all iterations of SPOR are completed; and
As other programmes, introducing new systems to support regulatory activities, are implemented and integrated with SPOR e.g. CESSP, Clinical Trials Portal
Benefits
Enabled by
Positive impact on public health and safety
E.g. product recalls, safety information and assessment
Operational savings and efficiencies
Increase in data quality, simplification of data management practices
Fulfil regulatory requirements more efficiently
Better decisions, faster regulatory action
Faster, more efficient regulatory action and decision-making
Data entered only once and reused across different procedures and regulators
Data reviewed, assessed and approved as part of the new data operating model
Reducing silos and improving interoperability across EU systems
Improved data integrity and reliability through centrally-held SPOR data 11
Industry Change Liaisons kick-off webinar

12. Key changes as a result of SPOR
06 May 2018
Key changes as a result of SPOR .
New ways of
accessing SPOR data
EMA IT Service Desk
(technical
support for stakeholders)
EMA Data Stewards
managing SPOR data
Data content:
RMS lists and
OMS dictionary
Data management
OMS and RMS Operating Models
Industry Change Liaisons kick-off webinar

13. Key changes as a result of SPOR
New ways of accessing SPOR data
SPOR web interface
SPOR APIs* (Application Programming Interface)
Draft APIs have been shared with SPOR Task Force; final APIs expected to be published end of July
For RMS, backward compatibility will be maintained with EUTCT for NCAs who use EUTCT
*An API is a mechanism to allow your IT systems to exchange information with RMS and OMS
Industry Change Liaisons kick-off webinar

14. Key changes as a result of SPOR
EMA Data Stewards
A specialised team of EMA staff will manage data on behalf of the Network and provide user support
Key activities of data stewards:
Manage data quality
Take action on change requests for new/amended Referential Lists/Terms and Organisation data
Validation of access requests to SPOR services
Industry Change Liaisons kick-off webinar

15. Key changes as a result of SPOR
Data content
RMS lists at go-live:
Lists from EUTCT (apart from Substance list)
Lists to support OMS
Lists for ISO (Pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO (Units of measurement)
Some lists to support  PMS project (e.g. Material)
Content of the OMS dictionary at go live:
MAHs: (H+V) CAPs & (H) NAPs
MAAs: (H+V) CAPs
MRL applicants (Vet)
MA & MRL contacts: (H+V) CAPs
RMS lists and content of the OMS dictionary will gradually be expanded. Please see Appendix for data release plans (slides 51 and 53)
Industry Change Liaisons kick-off webinar

16. Key changes as a result of SPOR
OMS Operating Model
Establishes a centralised dictionary of Organisations data to be used as a reference and in support of EU regulatory activities
EMA will host the Organisations master data and will provide access to all stakeholders
Common process which requires industry to request organisation registration (or update) with EMA before regulatory submission
NCAs will also be able to submit change requests (pre-register) to OMS
Organisation data will be validated by the EMA Data Stewards and available in a structured format
Please see Appendix for OMS operating model (slide 49)
Industry Change Liaisons kick-off webinar

17. Key changes as a result of SPOR
RMS Operating Model
EMA will act as the broker and it will provide Referentials data services to EU network
Referentials data maintained by EMA Data Stewards and available in structured format
EMA will host reference lists from different maintenance organisations (WHO, EDQM, MSSO, BfArM, etc)
EDQM: maintenance organisation for ISO IDMP (ph. forms, units of presentation, routes of administration, packaging)
BfArM: maintenance organisation for Units of Measurement (ISO IDMP 11240)
EMA will be a maintenance organisation for new lists where no maintenance organisation exists
Common process which requires industry and other parties to request registration of Terms before regulatory submission
Translations done by NCAs
All organisations need to register legacy & specific terms with EMA
Please see Appendix for RMS operating model (slide 51)
Industry Change Liaisons kick-off webinar

18. Key changes as a result of SPOR
EMA IT Service Desk
EMA IT Service Desk will provide technical support for SPOR data services for all stakeholders
More details on this will follow nearer go-live
Industry Change Liaisons kick-off webinar

19. Key changes as a result of SPOR
Data Management
Industry will need to synchronise data in their local systems with RMS and OMS on an ongoing basis
In order to reflect changes/updates in SPOR data in their local systems, Industry may need to transform their local data to align with ISO/EU data formats within RMS and OMS:
Data transformation – change the data structure e.g. split data fields
Data enrichment – complete the set of data e.g. add a new field such as post code
Industry Change Liaisons kick-off webinar

20. High level programme timeline
The focus for 2016 is on implementation of RMS and OMS
RMS and OMS will lay the data foundations for PMS and SMS
PMS and SMS projects are on hold until after RMS and OMS go-live
The plan for PMS & SMS will be shared once available
reduced
The 18 month (12+6) period is the minimum amount of time required to undertake these activities and as such will not be reduced 20
Industry Change Liaisons kick-off webinar

21. SPOR data services roll-out plan
This roll-out plan shows SPOR in the context of EU telematics programmes dependent on SPOR data.
It also sets out critical supporting activities required from NCAs and Industry, specifically relating to RMS and OMS 1 2 3 4 5 6

22. Key activities for Industry
06 May 2018
Key activities for Industry
The focus activity in 2016 relates to preparing for RMS and OMS go-live
Industry own their plans to design, implement, test and deploy changes in alignment with SPOR roll-out plan 1
Programme participation
Engage with programme via Industry Change Liaisons and existing forums eg. SPOR Task Force, Sub Groups
Support change management activities e.g. communications and training
Review programme documentation when required (via SPOR Task Force, Sub Groups activities)
Support planning and execution of UATs (via SPOR Task Force, Sub Groups activities) 2
Follow through on priorities
Undertake activities in order to be ready to actively use RMS and OMS post go-live
Follow the agreed RMS and OMS operating models post RMS and OMS go-live, which include pre-registration and ongoing maintenance of SPOR data 3
Data mapping
No OMS mapping is required by Industry prior to OMS go-live
No RMS mapping is required by Industry prior to RMS go-live.
Post go-live, Industry should map against new Referentials lists and new OMS dictionary content as it is published to provide a better foundation for Products
Post go-live, Industry should synchronise their local Organisation data against the OMS dictionary and their local Referentials data against existing RMS lists to provide a better foundation for Products 4
Data pre-registration
OMS go-live, Industry should send requests for new/updated Organisation data relating to MAHs only. As the dictionary is expanded with other types of Organisation data, Industry will be invited to pre-register data relating to these new Organisations.
Post RMS go-live, Industry should send requests for new/updated Referentials prior to submitting an application
The OMS project team are aware of the concern that data may need to be submitted twice and in different formats: to xEVMPD and to OMS.
They are investigating a mechanism to facilitate updating xEVMPD from OMS
If this is not possible, they will continue to perform delta loads from xEVMPD into OMS
Stakeholders will not be asked to submit data twice 5
Process
change
Identify all processes that will be impacted by the changes brought about by SPOR e.g. data synchronisation 6
Systems
change
Identify all impacted systems and architecture that will need to be adapted in order to support the process changes identified above 22
Industry Change Liaisons kick-off webinar

23. Introduction to Industry Change Liaisons
06 May 2018
Introduction to Industry Change Liaisons

24. Industry Change Liaisons
06 May 2018
Establishing our change network
At the February 2016 meeting of the SPOR Task Force, it was agreed that EMA needed to establish a framework to broaden its reach in distributing communications about SPOR
To achieve this, EMA developed a plan to establish and leverage a Change Network across regulators and Industry
NCA Change Liaisons were nominated in March and on-boarded in April
We are now expanding the network to include Industry Change Liaisons
We aim to have established the whole Change Network by the end of August
Jun
Feb
Mar
Apr
May
Jul
SPOR Task
Force – agreement to set up change
Network (NCA and Industry)
NCA Change Liaisons appointed
Kick off webinar to engage NCA Change Liaisons and present the plan
Follow-up webinar with NCA Change Liaisons
Industry Change Liaisons appointed
Industry Change Liaisons
kick-off webinar 24
Industry Change Liaisons kick-off webinar

25. Recruiting Industry Change Liaisons
Key EU Industry Associations represented in the Industry Change Network
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Biopharmaceuticals Enterprise (EBE)
Medicines for Europe (formerly EGA)
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
EuropaBio
International Federation for Animal Health – Europe (IFAH-Europe)
European Group for Generic Veterinary Products (EGGVP)
Vaccines Europe (VE)
Eye Care Industries European Economic Interest Grouping (ECI – EEIG)
Association of the European Self-Medication Industry (AESGP)
Europharm SMC – European Industry Association for small to medium-sized Pharmaceutical Companies - TBC
European Federation of Statisticians in the Pharmaceuticals Industry (EFSPI)
European CRO Federation (EUCROF) - TBC
Industry Change Liaisons have been drawn from the SPOR Task Force and are made up of representatives from:
Industry Associations
Vendors
The role of Industry Change Liaison formalises the communications aspect of their current role as Task Force members 25
Industry Change Liaisons kick-off webinar

26. Leveraging our Change Network
06 May 2018
Leveraging our Change Network
We have established a Change Network to help us broaden the reach of the EMA in communicating about SPOR
SPOR change team circulate finalised comms and training materials to change network:
Industry Change Liaisons*
EMA’s established contact points at Industry Associations
EMA’s SME stakeholder office
NCA Change Liaisons
SPOR change team develop communications and training material in consultation with key internal & external stakeholders:
EMA comms team
Focus Group (sub-set of Industry Change Liaisons)
1. EMA develops central communications and training materials
3. Change Network cascades materials across NCAs and Industry
2. EMA distributes materials to Change Network
Change Network may, if required, tailor central comms and training materials for their target audience before cascading to:
Target audiences across industry
National trade associations
SME audiences across Industry
NCAs
*Only Industry Association Change Liaisons have the responsibility to cascade communications. It is not a responsibility of Vendor Change Liaisons to cascade information, although they are free to share across their network if they wish. Industry Association Change Liaisons will be expected to include the Vendor community as a target audience.
Diagram illustrating the development and distribution of comms and training material 26
Industry Change Liaisons kick-off webinar

27. Roles within the Change Network
06 May 2018
Roles within the Change Network
We are introducing roles here but will go through each role in greater detail later in the presentation:
Industry Change Liaisons
SPOR Task Force members representing EU Industry Associations (Industry Association Change Liaisons) and Vendors (Vendor Change Liaisons)
Cascade communications material across Industry in an interactive way**
Promote sharing of best practice
Feedback on comms and training materials and activities
Members
Role
Focus Group
Subset of Industry Change Liaisons
Identify communication needs, key messages and target audiences
Where required, provide feedback on draft content
Members
Role
Lead contact points
Subset of Industry Change Liaisons
Coordinate across Industry Change Liaisons representing same Industry Association
Single contact point with EMA for feedback, questions etc
Members
Role
Contact points at Industry Associations (via EMA stakeholder office)
EMA’s established contact points at EU Industry Associations
Work with Industry Change Liaisons to cascade communications material across Industry
Members
Role
NCA
Change Liaisons
Nominees from NCAs
Cascade communications material to their own organisation and to their national trade associations, translating as needed
Members
Role
SME stakeholder office
EMA function that supports SME stakeholders
Cascade communications material directly to SME stakeholders that are registered with EMA
Members
Role
** not applicable to Vendor Change Liaisons 27
Industry Change Liaisons kick-off webinar

28. Cascading information
06 May 2018
Cascading information
It is the responsibility of the bodies which comprise the Change Network to ensure information reaches those stakeholders who need to be aware of SPOR and whose work will be impacted by SPOR
Please note: It is not a responsibility of Vendor Change Liaisons to cascade information, although they are free to share across their network if they wish. Industry Association Change Liaisons will be expected to include the Vendor community as a target audience
The focus group will help the EMA SPOR Change Team to identify the target audience of each communication so that clear guidance can be provided to the Change Network about who to target in affiliated organisations
The Change Network may find it appropriate to tailor the materials to suit the specific needs of target audiences. However, the key messages and intent must always be maintained
Industry Change Liaisons should work with EMA’s established contact points at Industry Associations to ensure a joined up approach to the cascade of any comms materials to Industry 28
Industry Change Liaisons kick-off webinar

29. Identifying target audiences in Industry
06 May 2018
Identifying target audiences in Industry
Stakeholder groups across Industry will be impacted to varying degrees by the changes brought about by SPOR
The Change Network should, from the organisations affiliated with them, identify key contacts representing these stakeholder groups
For example, the Industry Change Liaison from EuropaBio can look to Industry organisations affiliated with EuropaBio to identify key contacts for these stakeholder groups
These key contacts can help the Change Network to ensure the communication reaches its target audience
Industry Executives
Industry Representative Groups
Regulatory Executives
Regulatory Professionals (Global & Affiliates)
Manufacturing and Supply Chain Professionals
Patient Safety Professionals (Global & Affiliates)
Industry IT Professionals
Contract Research Organizations (Regulatory or Pharmacovigilance)
Contract Research Organizations (Manufacturing)
Clinical Professionals
Small to Medium Pharma Enterprises (SMEs)
Compliance & Risk Professionals
QPPVs
Clinical Trials Sponsors, other CT roles
Pharma Consultancies
Software Vendors
Target audience – Example stakeholder groups which may be impacted 29
Industry Change Liaisons kick-off webinar

30. Industry Change Liaison engagement approach
06 May 2018
Industry Change Liaison engagement approach

31. Principles of engagement
06 May 2018
Principles of engagement
To ensure Industry receives and understands information in support of SPOR’s implementation, EMA needs to:
Style of communications
Provide centralised communications to Industry Change Liaisons who will have the responsibility to cascade to the right people within impacted stakeholder organisations
Ensure every comms material is accompanied with clear guidance about its purpose, target audience and whether it is for information or consultation
Ensure information is provided through effective and accessible channels appropriate to the content eg. Webinar and online demos for training
Communicate relevant information on a timely basis while avoiding over-communication
Ensure that an IT-related technical background is not required to understand communications, except under specific circumstances
Assume limited prior knowledge of ISO IDMP and SPOR to accommodate the varying levels of engagement and awareness of stakeholders
Collaboration
Provide a mechanism that encourages open feedback and collaborative working between Industry representatives and EMA to optimise engagement as we go along
Encourage sharing of knowledge across Industry, good practice and lessons learned in relation to implementation activity
Share our proposed approach and plan with Industry Change Liaisons to obtain their feedback
Industry Change Liaisons kick-off webinar

32. Key engagement channels
06 May 2018
Key engagement channels
Key channels of communication between the Programme and Change Network – we will invite feedback from Change Liaisons on the efficacy and frequency of use of these
Targeted s to provide the Change Network with SPOR updates on comms, training, upcoming events and programme timelines
Mailbox to provide a central point of contact for the Change Network to the SPOR Change Team for questions, answers and to provide feedback on change activities
Webinars to deliver longer duration live communications to a large audience across the EU region in an interactive, engaging way. Also provides a forum for Q&As. Where appropriate, webinars will be recorded and posted online.
E-learning, Videos & Demos to provide short, bitesize chunks of information on key topics. These are easily digestible snippets of information (unlike recorded webinars which can last up to 3 hrs)
SPOR Task Force is an expert advisory/ working group, also communicates to all external stakeholders affected by the implementation of the ISO IDMP standards. Task Force receives regular updates on SPOR change management from the SPOR Change Team.
SPOR public website for information on SPOR, additional reference materials and videos on key topics
Industry Change Liaisons kick-off webinar

33. 2016 Change Network engagement plan
2016 Change Network engagement plan
This indicative plan focuses purely on engagement with Change Liaisons. We are undertaking change and communication activities for a wider audience e.g. updates to the external website, training and webinars.
Quarter 2 of 2016
Quarter 3 of 2016
Quarter 4 of 2016
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Programme milestones
OMS go-live
OMS UAT
RMS go-live
RMS UAT
Identify NCA Liaisons
HMA/IT Directors
EUNDB /
SPOR TF
EUNDB /
SPOR TF
Change Network
NCA Change Liaisons (Human, Human & Vet mixed, Vet only)
Industry Change Liaisons
NCA Change Liaison follow-up teleconferences
NCA Change Liaison kick-off
NCA Change Liaison follow-up webinar
Full day face-to-face NCA Change Liaison event - TBC
SPOR implementation questionnaire #1
Data mapping
webinar for NCAs
Veterinary NCAs / Vet Industry webinar
SPOR implementation questionnaire #2
Monthly update to entire Change Network
Prep TCs with
Industry Change Liaison coordinators
Prep TC with
Industry Change Liaison coordinators
Industry Change Liaison update webinar
Industry Change Liaison update webinar
Industry Change Liaison kick-off
Industry Change Liaison comms focus group TC
We are here
Industry Change Liaisons kick-off webinar

34. Your role as Industry Change Liaison
06 May 2018
Your role as Industry Change Liaison

35. Industry Change Liaison role in a nutshell
Industry Change Liaisons act on behalf of SPOR as advocates of the programme, communicating to stakeholders across Industry.
This involves:
Being the first port of call for stakeholders across Industry to provide them with:
Information
Answer questions
Receive feedback
Cascading communications and reinforcing key messages
Encouraging uptake of training and reinforcing understanding
There will be a need for the role to continue beyond 2016 to support future iterations of SPOR projects
** not applicable to Vendor Change Liaisons
Industry Change Liaisons kick-off webinar

36. Industry Change Liaison role profile (1 of 2)
This is the core role profile that applies to every individual acting as an Industry Change Liaison, with some exceptions for Vendor Change Liaisons
The greatest value will derive from Industry Change Liaisons who can engage stakeholders in a more direct and interactive manner, over and above simply signposting material via
Cascade central communications and training material across Industry**
Maintain key messages but adapt angle for different target audiences, as appropriate**
Use interactive channels eg. webinars, teleconferences for educating stakeholders and walking them through content (in addition to ) **
Connect people who have an interest in sharing best practice and lessons learned relating to SPOR implementation
Provide ongoing feedback and suggestions to the SPOR change team for improvement of change management activity and content
Industry Change Liaisons
SPOR Task Force members representing EU Industry Associations (Industry Association Change Liaisons) and Vendors (Vendor Change Liaisons)
Able to represent communications and training needs on behalf of impacted Industry stakeholders
Able to clearly and accurately articulate key messages of most interest to Industry stakeholders
Knowledge of target audiences
Ability to translate technical and business content to address audience information needs
Available for monthly teleconference with SPOR change team to discuss materials
Members
Key activities
Role profile
** not applicable to Vendor Change Liaisons
Industry Change Liaisons kick-off webinar

37. Industry Change Liaison role profile (2 of 2)
06 May 2018
Industry Change Liaison role profile (2 of 2)
A subset of Industry Change Liaisons will form the Focus Group. This group will have responsibilities in addition to the core Industry Change Liaison role:
A subset of Industry Change Liaisons will act as lead contact points, one drawn from each Industry Association. This group will have responsibilities in addition to the core Industry Change Liaison role:
Focus Group
Subset of Industry Change Liaisons
Lead contact points
Able to proactively take the lead in coordinating activity across the other Industry Change Liaison reps
Able to establish a good working relationship with EMA’s contact point at their Industry Association
Available to dedicate the small additional time involved with acting as a single contact point
A sufficient understanding of the central materials to be able to coordinate the adaptation of content for target audiences
Members
Key activities
Role profile
Collaborate with SPOR change team to:
Identify Industry communication and training needs
Identify key messages tailored to Industry stakeholders
Identify target audiences
Review and feedback on content of selected central communications and training materials
Able to represent communications and training needs on behalf of impacted Industry stakeholders
Able to clearly and accurately articulate key messages of most interest to Industry stakeholders
Knowledge of target audiences
Ability to translate technical and business content to address audience information needs
Available for monthly teleconference with SPOR change team to discuss materials
Many of the Industry Associations have more than one Industry Change Liaison rep. The lead contact point will coordinate across the other Industry Change Liaison reps from their Industry Association to:
Streamline cascading of central and/or adapted communications and training materials
Establish ways of working with EMA’s contact points at Industry Associations over cascading of materials
Act as a single contact point with the SPOR change team e.g. for providing feedback or fielding questions
Discuss potential need for a lead contact point to coordinate these activities for those IAs where there are multiple representatives. And equivalent for Vendor community, just one lead contact point to coordinate? Note, that this is a different role to focus group member whose specific function is around identifying and approving comms.
Potential responsibilities for lead contact point:
Single point of contact for channeling questions and consolidating feedback/suggestions between the ICL group and SPOR project team
Coordinator of other ICL reps for their IA or Vendor community to align on cascading material and adapting material for target audiences 37
Industry Change Liaisons kick-off webinar

38. Key activities for Industry
06 May 2018
Key activities for Industry
The focus for Industry activity in 2016 relates to preparing for RMS and OMS go-live
Industry own their plans to design, implement, test and deploy changes in alignment with SPOR roll-out plan timings 1
Programme participation
Engage with programme via Industry Change Liaisons and existing forums eg. SPOR Task Force, Sub Groups
Support change management activities e.g. communications and training
Review programme documentation when required (via SPOR Task Force, Sub Groups activities)
Support planning and execution of UATs (via SPOR Task Force, Sub Groups activities) 2
Follow through on priorities
Undertake activities in order to be ready to actively use RMS and OMS post go-live
Follow the agreed RMS and OMS operating models post RMS and OMS go-live, which include pre-registration and ongoing maintenance of SPOR data 3
Data mapping
No OMS mapping is required by Industry prior to OMS go-live
No RMS mapping is required by Industry prior to RMS go-live.
Post go-live, Industry should map against new Referentials lists and new OMS dictionary content as it is published to provide a better foundation for Products data
Post go-live, Industry should synchronise their local Organisation data against the OMS dictionary and their local Referentials data against existing RMS lists to provide a better foundation for Products data 4
Data pre-registration
At OMS go-live, Industry should send requests for new/updated Organisation data relating to MAHs only. As the dictionary is expanded with other types of Organisation, Industry will be invited to pre-register data relating to these new Organisations.
Post RMS go-live, Industry should send requests for new/updated Referentials prior to submitting an application
The OMS project team are aware of the concern that data may need to be submitted twice and in different formats: to xEVMPD and to OMS.
They are investigating a mechanism to facilitate updating xEVMPD from OMS
If this is not possible, they will continue to perform delta loads from xEVMPD into OMS
Whatever happens, stakeholders will not be asked to submit data twice 5
Process
change
Identify all processes that will be impacted by the changes brought about by SPOR e.g. data synchronisation 6
Systems
change
Identify all impacted systems and architecture that will need to be adapted in order to support the process changes identified above 38
Industry Change Liaisons kick-off webinar

39. Industry Change Liaison activities (1 of 5)
Programme participation will be the primary area of focus for Industry Change Liaisons 1
Programme participation
Industry activities
Engage with programme via Industry Change Liaisons and existing forums eg. SPOR Task Force, Sub Groups
Support change management activities e.g. communications and training
Review programme documentation when required (via SPOR Task Force, Sub Groups activities)
Support planning and execution of UATs (via SPOR Task Force, Sub Groups activities)
When ICLs should
carry out activities
Industry Change Liaison activities
Participate in webinars and other planned engagement activity with the Programme
Share their understanding of SPOR benefits, impacts and implementation activities with Industry stakeholders
Cascade communications and training material across Industry, actively encouraging uptake of training**
Collate feedback from Industry stakeholders on communications and training materials
Request Industry Associations to include a reference on their corporate website to SPOR. A link to the SPOR web pages should be provided**:
EMA home>Data Submission on Medicines>Implementation of ISO IDMP standards
Check in regularly to the publishing platform to stay up to date on available material to share with Industry stakeholders
Ongoing
Aug/Sep 2016
Comms: ongoing
Training: Sep-Dec 2016
Ongoing
Aug/Sep 2016
Ongoing 39
Industry Change Liaisons kick-off webinar
** not applicable to Vendor Change Liaisons

40. Industry Change Liaison activities (2 of 5)
Follow through on priorities
Industry activities
Undertake activities in order to be ready to actively use RMS and OMS post go-live
Follow the agreed RMS and OMS operating models post RMS and OMS go-live, which include pre-registration and ongoing maintenance of SPOR data
When ICLs should
carry out activities
Industry Change Liaison activities
Encourage stakeholders to actively access and use the central SPOR data post go-live, drawing their attention to relevant guidance materials
Encourage stakeholders to follow the RMS and OMS operating models, drawing their attention to relevant guidance materials
Ongoing: Info on access included in data mapping guidance available Aug 2016;
Training on use of RMS and OMS Nov/Dec 2016
Ongoing: Op model guidance available August 40
Industry Change Liaisons kick-off webinar

41. Industry Change Liaison activities (3 of 5)
Data mapping
Industry activities
No OMS mapping is required by Industry prior to OMS go-live
No RMS mapping is required by Industry prior to RMS go-live.
Post go-live, Industry should map against new Referentials lists and new OMS dictionary content as it is published to provide a better foundation for Products data
Post go-live, Industry should synchronise their local Organisation data against the OMS dictionary and their local Referentials data against existing RMS lists to provide a better foundation for Products data
When ICLs should
carry out activities
Industry Change Liaison activities
Reinforce the message to Industry stakeholders that post go-live, in order to support future submissions of Product data, it is in their interests to be ready to:
Map local Organisations and Referentials data against any new OMS dictionary content and new Referentials lists
Synchronise local Organisations and Referentials data with central data in RMS and OMS on an ongoing basis to maintain data alignment and accuracy
Use timeline slide in Appendix – focus on Industry data activities – as a tool for communicating these messages
Ongoing
Ongoing
Ongoing
Industry Change Liaisons kick-off webinar

42. Industry Change Liaison activities (4 of 5)
Data pre-registration
Industry activities
Post OMS go-live, Industry should send requests for new/updated Organisation data relating to MAHs only. As the dictionary is expanded with other types of Organisation, Industry will be invited to pre-register data relating to these new Organisations.
Post RMS go-live, Industry should send requests for new/updated Referentials prior to submitting an application
Industry Change Liaison activities
When ICLs should
carry out activities
Reinforce the following messages to Industry stakeholders:
Post go-live, follow the operating model by submitting requests for new/updated Organisations and Referentials data prior to submitting applications (pre-registration)
The initial release of the OMS dictionary will contain MAHs (NAPs/CAPs), MA applicant (CAPs), MRL Applicants
Further groups of Organisations will be added to the dictionary throughout 2016 and 2017
Only pre-register Organisation data after it has become available in the OMS dictionary.
Share with stakeholders the data release plans (see Appendix) indicating when data will be expanded**
Cascade communications notifying that new sets of Organisation data are available**
Ongoing
Aug-Dec 2016
Ongoing
Ongoing
Ongoing
From Dec 2016 (ongoing activity)
** not applicable to Vendor Change Liaisons
Industry Change Liaisons kick-off webinar

43. Industry Change Liaison activities (5 of 5)
Process change
Identify all processes that will be impacted by the changes brought about by SPOR e.g. data synchronisation 6
Systems change
Identify all impacted systems and architecture that will need to be adapted in order to support the process changes identified above
When ICLs should carry out activities
Industry Change Liaison activities
Reinforce the following message to Industry stakeholders:
In order to accommodate the key changes that SPOR implementation will bring about, they will need to identify systems and processes that touch SPOR data and be ready to adapt them post go-live
Draw stakeholders’ attention to material providing guidance on options for synchronisation approaches**
Ongoing
Aug-Dec 2016:
Info on synchronisation included in data mapping guidance and API specifications available Aug 2016
** not applicable to Vendor Change Liaisons
Industry Change Liaisons kick-off webinar

44. 06 May 2018
Next steps

45. Key action points for Industry Change Liaisons (1 of 2)
06 May 2018
Key action points for Industry Change Liaisons (1 of 2) 1
Establish your communications network**
Introduce yourself as Industry Change Liaison for SPOR to Leadership and other relevant contacts within your Industry Association
Link in with EMA’s established Industry Association contact points to establish a joined up approach to the cascade of any comms materials to Industry
Establish the channels you will use for cascading central communications internally across your Industry Association and externally to target audiences in affiliated organisations
Due to data protection we cannot make your personalised address public for use by Industry stakeholders. Therefore please set up a de-personalised inbox and send us the address so that we can share it publicly. Please send the address to by Thursday 28 July 2016
We would like to share contact names and addresses for each Industry Change Liaison and Industry Association contact point with this group and with NCA Change Liaisons. Please let us know if you do not wish to share your personalised address with this group. 2
Nominate lead contact points**
Industry Association Change Liaisons representing the same Industry Association should agree who among them will act as lead contact point.
Please your nominee’s name to by Thursday 28 July 2016.
** not applicable to Vendor Change Liaisons
Industry Change Liaisons kick-off webinar

46. Introduction to SPOR data services
06 May 2018
Key action points for Industry Change Liaisons (2 of 2) 3
Undertake Industry Change Liaison activities
Take note of the activities as specified in slides and start to undertake them in line with the indicated timings 4
Encourage SME stakeholders to register with EMA
If they are not already registered with EMA’s SME office, please ensure SME stakeholders are aware of the financial and administrative benefits of registration by directing them to the EMA SME web page:
ema.europa.eu>Human regulatory>Supporting SMEs
ema.europa.eu>Veterinary regulatory>Supporting SMEs 5
Communicate upcoming events
Introduction to SPOR data services
Thursday 4 August, GMT
This is an awareness session to help Industry understand what SPOR is, why, when and how we are implementing it
We need your help to encourage as a broad an audience across Industry as possible
We will record the broadcast and make it available online for those unable to participate
We encourage you to proactively share the content from this webinar with Industry stakeholders
Industry Change Liaisons kick-off webinar

47. 06 May 2018
Appendix

48. Appendix content Slide # OMS operating model______________________50
06 May 2018
Appendix content
Slide #
OMS operating model______________________50
OMS data release plan_____________________51
RMS operating model______________________52
RMS data release plan_____________________53
Operating model advantages________________54
RMS & OMS services_______________________55
SPOR reference sources and material_________56
Draft communication plan__________________57-58
NCA Change Liaisons______________________59
Focus on Industry data activities_____________60
The Appendix includes further information that we recommend you take away and review in your own time.
It contains basic information about the RMS and OMS operating models and a list of services that will be provided by the new RMS and OMS systems.
The broadcast on 4th August will walk participants through the operating models more thoroughly and a detailed guidance document will be published online in August.
The draft communications plan is only indicative and intended to give a flavour of the type of materials and events that we will be asking ICLs to cascade
Please check out the list of reference material to give you an understanding for what type of detailed documentation will be available online for you to signpost to stakeholders. As and when we publish materials, we will let you know so that you can stay up to date on what is held in this repository.
We include a list of the NCAs represented in the Change Network. We will try to secure permission from NCA Change Liaisons to share their names with you so that all members of the Change Network can be known to each other.
We included a timeline showing data-related activities. ICLs may find this a useful tool for communicating with stakeholders about what needs to be done with data and when.
Industry Change Liaisons kick-off webinar

49. OMS Operating Model – Phase I
OMS Operating Model – Phase I
This operating model is endorsed by TMB 49
NCA Change Liaisons – 26 May 2016

50. Organisations data release plan
Industry should only start submitting Change Requests for Organisations once the data is published in OMS – not before.
Key
Points at which new organisation data is published in OMS
OMS go live
EMA will issue advance communications to notify all stakeholders that new data is being published on OMS and that Change Requests for that data can be submitted now that it has been published on OMS (not before).
OMS Live
Q4 2016
Q1 2017
Q3 2017
Q4 2017
2018 / 2019
TBD: CROs; CT site; Academia; Hospitals; Distributers etc.
Manufacturers:
(H+V) NAPs
MAHs: (H+V) CAPs & (H) NAPs
MAAs: (H+V) CAPs
MRL applicants (Vet)
MA & MRL contacts: (H+V) CAPs
Sponsors
Regulatory Authority
/NCAs
Manufacturers:
(H+V) CAPs
Industry Change Liaisons kick-off webinar

51. RMS Operating Model Regulator/Interested party Broker
(Request new/updated term; Consume and use)
Broker
(Register requests; make data available)
Maintenance Organisation
(Data management activities)
Data Owner
(Decide content; mapping legacy data/specific extensions; translations)
EMA
EDQM
ISO 11239
- Pharm Dose Forms
- Unit of Presentation
- Packaging
- Route of Admin
EDQM
ISO 11239
- Pharm Dose Forms
- Unit of Presentation
- Packaging
- Route of Admin
Industry
EMA/Bfarm
ISO 11240
- Units of Measurement
EMA/Bfarm
ISO 11240
- Units of Measurement
EMA
NCAs
ISO
Other (not ISO IDMP)
- Country
- Language
ISO
Other (not ISO IDMP)
- Country
- Language
MSSO/ICH
CVs to support (P)
- MedDRA
MSSO/ICH
CVs to support (P)
- MedDRA
FDA/JP?
WHO
CVs to support (P)
- ATC H
- ATC V
- INN
WHO
CVs to support (P)
- ATC H
- ATC V
- INN
EMA
EMA
New CVs to support (S)
New CVs to support (P)
Non ISO IDMP lists
EMA
New CVs to support (S)
- Many Lists
New CVs to support (P)
Non ISO IDMP lists
- CVMP
- SIAMED
- Esubm TIGES
- EudraCT TIGES
Industry
EMA
NCAs
EMA
Mappings
FDA
Mappings
FDA/JP?
NCAs
Mappings & Translations
Industry
Mappings & Translations

52. Referentials data release plan
Post go-live users should access RMS and subscribe to be notified whenever a new list has been published
Stakeholders should only start submitting Change Requests for Referentials once the data is published in RMS – not before.
Key
Points at which new Referentials list will be added
RMS go live
Q4 2016
RMS Live
RMS lists at go-live:
Lists from EUTCT (apart from substance list)
Lists to support OMS project
Lists for ISO (Pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO (Units of measurement)
Some lists to support PMS project (e.g. Material)
Further lists to support PMS and SMS to be included as and when available
Industry Change Liaisons kick-off webinar

53. Operating Model advantages
SPOR data is hosted by EMA, accessible to and used throughout EMA and by external stakeholders
SPOR data is a single and trusted source of data
Common process which requires industry and other parties alike to request registration of Referentials and Organisations data before regulatory submission
Common process to request changes to the OMS dictionary and to Referentials lists/terms
Referentials and Organisation data validated by the EMA Data Stewards and available in a structured format
Establishes a complete and high quality dictionary of Organisations and lists of Referentials terms to be used as a reference and in support of EU regulatory activities
Single format and simplified process to consume Referentials lists and keep them updated
NCA Change Liaisons – 26 May 2016

54. ID Translation Service
06 May 2018
RMS and OMS Services
The use cases and operating models for SPOR require stakeholders to interact with SPOR data. To support these interactions, stakeholders will be able to make use of SPOR data services:
Customer support
RMS & OMS
Customer support: business/technical queries; issues; training
All users authenticated & authorised
Browse data
Change requests
RMS
List of lists
List of terms incl. Term Summaries & Term details
OMS
List of organisations with location addresses
All Org_IDs and Org_Loc_IDs
RMS
Search
Read
New/update/delete Term Request
New/update List Request
Document attachments
OMS
Create/Update Org/Location
Add location
Multi-lingual
OMS
Organisation name
Location addresses
Term Translations
RMS
Search
Read/ Update
Search
ID Translation Service
RMS
Standard and advanced search (UI)
Google-style search (API)
Lists and terms
Historical versions (date/version number)
OID for sources of information
Language(s)
Applicability
OMS
Standard search
Org and Location data
Historical versions (date/time stamps)
Based on source system/other IDs (e.g. EV_Code, DUNS/GTIN, etc)
RMS
Source term ID into RMS ID
Export
RMS
List of lists
List of terms
Full list or set of results
Filter By Languages
OMS
Full dictionary or set of results
File contains: all versions, Org name and location address in all languages, source system IDs, international organisation identifiers, etc
Saved queries
RMS
Search queries
Crate/update/delete queries
Tags
RMS
Search
Create/Update/Delete
Subscriptions
RMS
Search
Create/Update/Delete
Documents
RMS & OMS
View & Publish documents
Industry Change Liaisons kick-off webinar

55. SPOR reference sources & material
ISO IDMP web page
Overview of ISO IDMP
SPOR roadmap
Links to ISO standards
SPOR Task Force terms of reference and meeting minutes
Links to key reference material (in progress)
Publishing platform (in progress)
Key reference material published here
Key reference material:
Coming in August:
Roll-out plan for RMS and OMS
Stakeholder engagement approach
SPOR high level benefits
High level changes as a result of SPOR
RMS and OMS operating model guidance
Expansion timelines of RMS lists and OMS dictionary
Data mapping guidance for Referentials and Organisations
RMS and OMS data models
RMS and OMS APIs
RMS and OMS use cases
Industry Change Liaisons kick-off webinar

56. Draft 2016 communications plan (1 of 2)
06 May 2018
Draft 2016 communications plan (1 of 2)
All content contained within the plan is subject to Programme timelines and activity, therefore proposed content of communications is likely to change
Monthly update to Change Network
Other
Jun
Flag data mapping webinar
Flag veterinary webinar
Outcomes from HMA/ITD
Jul
Outcomes from EUNDB/SPOR TF
Comment on Industry Change Liaison kick-off
Outcomes of re-planning exercise
Flag broadcast to Industry
Flag UAT
Flag NCA & Industry Change Liaison F2F
Kick-off webinar to on-board Industry Change Liaisons
Aug
Flag RMS and OMS UAT
Overview of training offerings
Flag Pulse survey on change management
Flag HMA meeting
Request for speakers at Best Practice forum
Introduction to SPOR broadcast for Industry
Monthly focus group TC
Roll out reference material published online
Industry Change Liaisons kick-off webinar

57. Draft 2016 communications plan (2 of 2)
Monthly update to Change Network
Other
Sep
Outcomes from UAT
Flag training events
Outcomes from HMA meeting
Flag Best Practice forum
Industry Change Liaison update webinar
Roll out reference material published online
Monthly focus group TC
Pulse survey on change management
OMS & RMS training events commence
Oct
Request feedback on training
Flag OMS go-live/post go-live support
Flag EUNDB/SPOR TF
Best Practice forum
Nov
Flag OMS and RMS go-live and post go-live support
Dec
Go-live communications
Overview of planned activity in 2017
Industry Change Liaisons kick-off webinar

58. NCA Change Liaisons
A representative from each of these organisations has been invited to engage with EMA over SPOR change management activity:
Country
Organisation
Austria
Austrian Medicines and Medical Devices Agency (AGES-MEA)
Belgium
Federal Agency for Medicines and Health Products (FAMHP)
Bulgaria
Bulgarian Drug Agency (BDA)
Croatia
Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Cyprus
Department of Information Technology Services (DITS), Ministry of Health
Veterinary Services - Ministry of Agriculture, Rural Development and Environment
Czech Republic
State Institute for Drug Control (SÚKL)
Denmark
Danish Medicines Agency (DKMA)
Estonia
Estonian State Agency of Medicines (SAM)
Finland
Finnish Medicines Agency (FIMEA)
France
National Drug and Health Products Safety Agency (ANSM)
French Agency for Veterinary Medicinal Products (Anses-ANMV)
Germany
Paul-Ehrlich-Institut
Federal Institute for Drugs and Medical Devices (BfArM)
Hungary
Directorate of Veterinary Medicinal Products, National Food Chain Safety Office (NFCSO - NEBIH)
National Institute of Pharmacy and Nutrition (OGYEI)
Iceland
Icelandic Medicines Agency (IMA)
Ireland
Health Products Regulatory Authority (HPRA)
Italy
Italian Medicines Agency (AIFA)
Country
Organisation
Latvia
State Agency of Medicines (ZVA)
Liechtenstein
Office for Public Health
Lithuania
National Food and Veterinary Risk Assessment Institute (VET)
State Medicines Control Agency (SMCA - VVKT)
Luxembourg
Ministry of Health Luxembourg
Malta
Medicines Authority Malta
Netherlands
Norwegian Medicines Agency (NoMA)
Norway
National Authority of Medicines and Health Products, IP (INFARMED)
Portugal
Portuguese National Authority for Animal Health, Directorate General of Food and Veterinary (DGAV (DGAMV))
National Agency of Medicines and Medical Devices (ANM)
Romania
Slovakian Medicines Agency - State Institute for Drug Control (SUKL)
Slovak Republic
Institute for State Control of Veterinary Biologicals and Medicaments
Agency for Medicinal Products and Medical Devices (JAZMP)
Slovenia
Spanish Agency of Medicines and Medical Devices (AEMPS)
Spain
Medical Products Agency (MPA)
Sweden
Medicines Evaluation Board (CBG-MEB) UK
Medicines & Healthcare products Regulatory Agency (MHRA)
Veterinary Medicines Directorate (VMD)
(as at 5 May 2016)
Industry Change Liaisons kick-off webinar

59. Focus on Industry data activities
06 May 2018
Focus on Industry data activities
Aug 2016
Sep 2016
Oct 2016
Nov 2016
Dec 2016
Jan 2017
Feb 2017
Mar 2017
RMS
go-live
OMS
go-live
RMS
Standardise any free text package descriptions using the categories of package descriptions terms in the Containers list from EDQM
Update local Containers data (inc standardised package descriptions) against existing Container list in RMS
Update local Referentials data against existing RMS lists
Map local data against new Referentials lists as they are made available
Submit requests for new/updated Referentials terms prior to submitting applications (pre-registration)
Keep local Referentials data synchronised with RMS
OMS
Submit requests prior to submitting applications
(pre-registration) for new/updated data relating to:
MAH (NAPs/CAPs)
MA applicant (CAPs)
MRL Applicants
Map local data against OMS dictionary at go-live and when new data becomes available in line with data release plan
Submit requests for new/updated Organisations data prior to submitting applications (pre-registration)
Keep local Organisations data synchronised with OMS 59
Industry Change Liaisons kick-off webinar

60. Thank you for your attention
06 May 2018
Thank you for your attention
Further information
Please send any queries for the change team to:
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0) Facsimile +44 (0)
Send a question via our website
Note: This slide is OPTIONAL. It uses the 'Closing slide' layout. Delete if not needed.
Follow us on @EMA_News