echa’s minimum viable product...minimal viable product 11 • to support the offer, echa defines...
TRANSCRIPT
• In answer to EFSA’s request on the possibility to use
IUCLID for pesticides-related submissions in relation to the
regulation on transparency and sustainability of the EU risk
assessment in the food chain (Regulation (EU) 2019/1381)
ECHA’s Minimum Viable Product
Background information
Chemicals legislations managed by ECHA
3
REACHRegistration
Evaluation
Authorisation
All chemicals
>1 tonne
per annum
CLPClassification
Labelling
Packaging
All chemicals
and mixtures
UN-wide standards
BPRBiocides
Active substances
and biocidal
products
PICPrior Informed
Consent
Import/export of
certain hazardous
chemicals
Rotterdam
Convention
Wealth of information
Companies are required to collect or generate information on properties and uses of their chemicals,
assess the risks and recommend safety measures.
All this information is submitted to ECHA
More recently: Waste Framework Directive
and Drinking Water Directive
Data dissemination
4
ECHA Dissemination
website
REACH-ITREACH-IT
Data
gen
era
tio
n
Data storage Dossier preparation
Data gaps fillingTrend analysis
Safety assessment
Data
an
aly
sis
Advanced analytics
Text mining tools
Data Integration platform
Data aggregation
Data enriched with external sources D
ata
Dis
sem
inati
on
ECHA Dissemination portal:raw data, Reports & statistics
Public data synchronised with OECD eChemPortal
Interactive dashboards with MS
Data
su
bm
issio
n
Transactional systems
REACH-IT
R4BP (biocides)
ePIC
Industry Tools
Industry channel
ECHA Enterprise Architecture
5
IUCLID &
Plugins
Chesar
REACH-IT
(Industry Access)
R4BP
(Industry Access)
Misc. Web forms
IUCLID Online
Dossiers
Member State
Authority
Scientific Evaluation Support
Enterprise Content Management
Document Management System
Records Management
Dynamic Case (Internal Case Management)
Identity
Access M
anagem
ent
EnforcementDissemination Platform
IUCLID-Public
Public Access channel
ECHA Website
eChem Portal
Public
Authorities channel
Identity
Access M
anagem
ent
Portal Dashboard (CAs)
Portal Dashboard (NEAs)
REACH-IT (CA Access)
R4BP(CA Access)
IUCLID (CA Access)
Industry
Misc. Web forms
Odyssey
Data Management Core
Data Integration Platform
Data
HubData
WH
ET
L
IUCLID-Agency
Da
ta d
eliv
ery
Data mining & analytics
Knime
Misc. Data
sourcesBOs
Text Analytics
IUCLID distributions and related tools
Desktop
Server
Cloud
Text analytics & Data extractor
• Drafted by an ad hoc group of Expert Panel members
• Published since Feb. 2019
• Outlines the possibilities for customising IUCLID for use
in different jurisdictions and extension and integration
with other tools
– Role in international cooperation & process for
global harmonisation of data elements
– Customisable elements: IUCLID format, features
and add-ons
– System to system integration
– User stories: customisation, legacy data migration,
alternative UI development on top of IUCLID
– OECD activities and procedures
… IUCLID also does it for other countries
IUCLID - International activities
• EU (incl. EFSA,
JRC)
• NICNAS,
Australia
• Canada
• Turkey
• Israel
• Japan
• Mexico
• New Zealand
• Taiwan
• South Korea
• US EPA
• Brazil
• Switzerland
Cooperation on IUCLID (activity in 2019)
IUCLID pilot for pesticides
Reuse existing format for a pilot phase and plan first adaptations and extensions for October 2020
Format
Pesticides Active Substances (+ Pesticides Products), already for October 2019
Submission types
Focus on Admissibility / Completeness Check in two steps: April and October 2020
Validation rules
Draft assessment report
List of studies
List of confidentiality claims - 2020
Reports
Preparation of filtered dossiers for publication of the Dossier Summary (April 2020)
Filtering rules
High level plan and stakeholders’ group activities
Task Name Duration Start
Stakeholder Meetings 59 days Thu 21/11/19
Access to Cloud and quick demo of IUCLID 1 day Thu 21/11/19
Submission types for pesticides: how to collect feedback 1 day Thu 28/11/19
Presentation POC project 1 day Thu 05/12/19
Validation assistant (how to use it during the pilot), review of rules used for admissibility
1 day Thu 12/12/19
Annotations and communication with applicant 1 day Thu 19/12/19
Progress and priority actions for 2020 1 day Thu 09/01/20
Dossier update (addressing annotations) and comparison tool
1 day Thu 16/01/20
Use dissemination preview to simulate dossier sanitisation
1 day Thu 23/01/20
Report generation (DAR) 1 day Thu 30/01/20
Edition of DAR and use of annotations for evaluation 1 day Thu 06/02/20
Multiple applicants 1 day Thu 13/02/20
Renewal dossier 1 day Thu 20/02/20
IUCLID Technical Group Meeting 39 days Tue 10/12/19
IUCLID Technical Group Core meeting 1 day Tue 10/12/19
IUCLID Technical Group Core meeting 1 day Tue 14/01/20
IUCLID Technical Group Core meeting 1 day Tue 11/02/20
ECHA’s proposal for a Minimum Viable Product
What can ECHA provide by end of 2020 to support
pesticides-related submissions
• ECHAs offering is based on enhancing the already existing and functionally complete ECHA
Cloud Services
– IUCLID software and IUCLID data format
– Submission portal
– Data operations
• ECHA offers a platform that supports
– Plant Protection Product Dossier operations
– Authorities assessment operations
– Prepare datasets for publication
– Hosted infrastructure
Minimal Viable Product
11
• To support the offer, ECHA defines three major user bases, along with EFSA,
and will discuss how each uses the environment
– Industry Users
– Authority Users including EFSA specific actions
– Public Users
Usage
12
Industry Users
• Authenticated and hosted PPP
authorisation platform supporting
– Dossier Preparation
– Confidentiality Claiming
– Dossier Submission and Updating
– Dossier Validation
– Dossier Versioning
– Reuse of datasets
• Submission support for
– New Submissions
– Renewal Submissions
– Update to ongoing authorisation
13
Industry
EFSACORE
EFSAPUBLIC
IndustryInstance X
E-Delivery
EFSADMS
Update
Submission Module
AnnotationConfidentiality Claim
Filter
Validation Assistant
Sharing
Presentation Layer
Event Logger
DashBoard
www
MSR
Ticketing System HelpDesk
ATD
Access
EC EFSA
Industry
EFSACORE
EFSAPUBLIC
IndustryInstance X
E-Delivery
EFSADMS
Update
Submission Module
AnnotationConfidentiality Claim
Filter
Validation Assistant
Sharing
Presentation Layer
Event Logger
DashBoard
www
MSR
Ticketing System HelpDesk
ATD
Access
EC EFSA
Authorities
• Automated Actions on Dossiers
– Dossier Validation
– Cross Checking with related
data
– Notifications
– Dossier public data readied for
publication
• Assessment Tools
– Dossier dashboard
– Commenting / Annotation
– Contextual menu for operations
14
Industry
EFSACORE
EFSAPUBLIC
IndustryInstance X
E-Delivery
EFSADMS
Update
Submission Module
AnnotationConfidentiality Claim
Filter
Validation Assistant
Sharing
Presentation Layer
Event Logger
DashBoard
www
MSR
Ticketing System HelpDesk
ATD
Access
EC EFSA
Public Users
• Accessible website hosting all
public aspects of dossiers
(dossier viewer)
• Sanitised dossiers only hosted
on public instance i.e. all
confidential items are removed
and a public consumable
dossier generated
• Means to transfer public
dossiers between instances to
support EFSA dossier review in
advance of publication
15
Minimum Viable Product
• The MVP provides EFSA with
additional items outside the usage
cases
– Secure authenticated platform
– Single environment for all
authorisation operations
– Static document that can only
be updated by the submitter
– Audit trail of events performed
on dossiers
– Dossier versioning
16
Industry
EFSACORE
EFSAPUBLIC
IndustryInstance X
E-Delivery
EFSADMS
Update
Submission Module
AnnotationConfidentiality Claim
Filter
Validation Assistant
Sharing
Presentation Layer
Event Logger
DashBoard
www
MSR
Ticketing System HelpDesk
ATD
Access
EC EFSA
• Post-Pilot Phase 1
– Work to the go-live deadline
• Post-Pilot Phase 2
– Post go-live enhancements that support the immediate requirements of
authorities that were not priority for go-live
• Strategic
– Strategic engagement to support better automation, refinement of actions
based on usage, presently out-of-scope items that could benefit from
using IUCLID
Timelines
Three main phases defined for the project
17
2019 2020 2021 2022
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 …
18
Strategic
27.03.2021
Entry into force of
GFL
Post Pilot Phase 1Pilot
ICULID 6.5 – End Oct
Post Pilot Phase 2
WP04: Project ManagementPPP Pilot & InceptionPlant
Protection
Product
WP01: PPP Type
WP06: ECOMOD PPP elaboration
WP05: IUCLID PPP construction & transition
WP08: ECOMOD PPP development & deployment iteration 1
WP13: IUCLID PPP improvements & refinements
WP16: ECOMOD PPP development & deployment iteration 2
WP10: DISS PPP inception
WP18: DISS PPP improvements and refinements
IUCLID
ECHA
Cloud
Services
Public
WP02: Filtering
EFSA
Co-ordinate Pilot actions with stakeholders
Engage contractor for
Dossier
Implement in-scope GFL solutions
WP11: DISS PPP construction & transition
Pilot Phase 1 Ends
20.02.2020
WP21: ECOMOD PPP development &
deployment strategic iterations
WP20: IUCLID EFSA improvements &
refinements
WP15: IUCLID EFSA construction & transition
WP22: CONS PPP improvements and
refinements
Engagement for strategic goals of ECHA and EFSA
Collaborative projects based on PPP successes
OPS: PPP Operational Management
Go Live – End Dec
OPS: PPP Solution Management
WP19: CONS PPP construction & transitionWP12: CONS PPP Inception
WP14: IUCLID EFSA Inception
WP03: Report Generation
WP09: ECHACS enhancements, industry focused
WP17: ECHACS enhancements, authority focused
WP07: ECHACS enhancement elaboration
Use case Overview
19
ECHA CloudService
Submitter EFSA
ECHA
Monitor Service
EFSA system
Communication
RMS
Communication
v1.2.0 22/01/2020
Publication
Dissemination
Search
Public
Dossier Creation
Dossier Submission
Dossier Updating
Notifications
Dashboard
Operations
Notifications
Dossier Comments
Dossier Comparison
Access IUCLID API
Notifications of Studies
DashboardOperations
Notifications
Dossier CommentsDossier Annotations
Request for information from Submitter
Filtering
Dossier Annotations
Pre-Submission Analysis
EU Systems
User Account Management
Single Sign-On
Already ExistingGo Live
DevelopmentPost Go Live
Authentication
Report Generation
Dossier ComparisonsReport Generation
Thank you!