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Update on theImplementation of
Transparency Regulation
Claudia Paoletti
Programme Manager
Management Board, 14 October 2021
ART progress update (June-September)
Why and how does ART continue?
External Communication & Engagement
Work on-going
Agenda
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The ART 2022 projects:
➢ enhance efficiency
➢ enhance automation
Why does ART Continue?
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➢ address the needs of the EC comments on Practical Arrangements from mid-2020 which could not be included in the April deliverables
Focus of ART 2021 was always the implementation of minimum requirements for the Transparency Regulation, delivered in short time and on budget.
The next phase of ART programme until end of June 2022:
➢Enhancement of new processes and supporting IT tools
➢Continuation of Customer Relationship Management processes and supporting tools
➢Development of IUCLID 2
➢Enhancement of confidentiality process and implementation of redaction software
Where we left in June
➢Finalise the implementation of enabling services
➢Implement the new processes and the new organigramme
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Agenda
ART progress update (June-September)
Why and how does ART continue?
External Communication & Engagement
Work on-going
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Organisational Design Project (ODP)
▪ Postponed due to COVID. Necessary to align the organisation to the new TR capabilities and Strategy 2027
Risk Assessment Project (RAP)
▪ Enhancing the minimum viable solution delivered for TR compliance
IUCLID Release 2
▪ Mainly enhancing and filtering dissemination and dossier structure
▪ Necessary to integrate IUCLID with EFSA confidentiality assessment
ART 2022: six projects
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Confidentiality Assessment and Sanitisation Project (CASA)
▪ Mainly to address PA comments requiring EFSA redaction and sanitisation of dossier
Customer Relationship Management Project (CRM)
▪ To improve the process for managing third parties and master data
Enabling Services Project (ESP)
▪ To consolidate management services and complete post-COVID new normal building works
ART 2022: six projects
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Agenda
ART progress update (June-September)
Why and how does ART continue?
External Communication & Engagement
Work on-going
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▪ Based on collection and analysis of external parties’expectations and needs
▪ To ensure stakeholders, Member States and the publicreceive timely information
▪ Through EFSA website, targeted communication viaSalesforce, stakeholder newsletters, social media
▪ In close liaison with DG SANTE
▪ Stakeholder initiatives:
o Continuous updated training programme
o Targeted webinars 1/month
o Targeted communication following tool upgrades/newrelease
o Dedicated LinkedIn group
o Dedicated SME event (Q1, 2022 TBC)
o IUCLID: IUCLID Hypercare, Pesticides Steering Network(PSN) IUCLID sub-group
o Technical Group on the Notification of Studies Database
External Communication and Engagement
Targeted proactive external communication/engagement across all projects
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Agenda
ART progress update (June-September)
Why and how does ART continue?
External Communication & Engagement
Work on-going
10
▪ Projects continue to enhance the solutions beyond minimum Transparency Regulation measures. However, the solutions are operational since March
▪ Enhancement priorities are agreed with SANTE through a common cross-border governance of requests
▪ ECHA has delivered a functioning consolidated e-submission portal for pesticides. Enhancements, integration for confidentiality assessment ongoing
▪ Specific change management support in place to assist all staff in the transition which is still challenging
▪ External communication targeted activities
Work on-going
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