DI conference – 28 May 2008 (Pre-)SIEF in practice Jack Wille - Cefic.

DI conference – 28 May 2008

(Pre-)SIEF in practice

Jack Wille - Cefic

DI conference – 28 May 2008 - page 2

SIEFreach

Agenda:– Introduction / Background– System overview

• The overall process

• Data transfer from ECHA REACH-IT system into SIEFreach

• Setup company structure / User accounts

– How work inside a SIEF– Payment of fees– Beyond the SIEF: Joint Submission


SIEF IT system project - Background

• The obligation to share animal study data in SIEFs (Substance Information Exchange Fora) and Submission of a Joint Registration:

– is industry’s responsibility – the European Agency (ECHA) will not be involved– therefore industry has to find a solution

• Cefic initiative: IT platform giving service to all industry, providing for:– Collaboration of companies in SIEF formation & sharing of data, identification of data

gaps, cost sharing, etc.– Secure communication inside and between SIEFs

• Benefits for companies of a SIEF IT platform:– Consistent processes and procedures – No need for individual solutions (reducing complexity)– Reduced investment and lower operational cost per company

• What if not such a system…….:– Multiple other (independent) SIEF IT systems by industry sector, for consortia, etc.– Email communication for SIEF communication

less efficient / more time consuming


SIEF IT system Project – Timing

– Project kick-off (Requirements Definition) 31 July 2007

– Start Build-phase 8 Jan. 2008

– User Acceptance test-1 21 May 2008

Test-1 with ECHA REACH-IT system 22-23 May 2008

– User Acceptance Test – 2 16-20 June 2008

– Implementation:• Release 1.0 Early July 2008• Release 2.0 (Invoicing, reporting) August 2008• Release 3.0 (Splitting / Merging SIEFs) 1 Dec. 2008


CentralIUCLID5database

Pre-Registration

Registration

SIEFreach

ECHA

Industry

(Joint)Dossier

Preparation

SIEF IT system project

Pre-Registrationdata

IUCLID5system

ECHA Pre-SIEF data is the source for SIEF

REACH-IT system


SIEFreach – Key components

• A common system for SIEF participants (consistency)

• Used across different industries (chemical, cosmetics, paper, etc.)

• Based on ECHA Pre-SIEF data:

– Enable Pre-SIEF / SIEF discussions using collaboration tool features

• Free access area vs. ‘paid’ area

• Predefined roles / privileges:

– SIEF Formation Facilitator, SFF, Lead Registrant

– Legal Entity Group Administrator

– Legal Entity User (one primary user per LE / Substance)

– Invited Expert

– Data Holder


SIEFreach – IT Infrastructure

• Robust, scalable system configuration (servers, database, network)IT Service Provider: IBM

• Sub-systems designed under ‘umbrella’ of Portal software

• Redundant installation to limit system downtime (max. 24 h.) (Disaster recovery site)

• Service Desk to resolve problems

• 3 main sub-systems:– Legal Entity / User Management– SIEF collaboration / processing (based on Lotus QuickR software)– Invoicing (fee collection)


SIEF IT system – Company launched

• Dedicated company established (ReachLink)

• Shareholders: Cefic + National Federations:– Germany – VCI– France – UIC– Italy – Federchimica– UK – CIA– Spain – FEIQUE

• ReachLink owns and manages the system

• Management Board (Shareholder representatives)User Committee and Steering Committee

• Managing Director hired

• Marketing / Communication campaign started 2H-May 2008


SIEF IT System

• Benefits: – Streamlined transparent communication between parties – Consistent processes and procedures – Tracking of all discussions / decisions during SIEF life time– Designed in collaboration with major players in the

Chemical Industry– ECHA pre-SIEF data is the basis for the SIEF– No need for individual solutions (reducing complexity)– Lower operational cost per company– Controlled access & Secured communication– Guaranteed platform till at least 2018


SIEFreach







Registration

SIEF IT system

Agency

Industry

(Joint Submission) Dossier

Preparation

Pre-Registration / SIEF / Registration process

IUCLID5

ECHA Pre-SIEF data is the basis for SIEF-IT system

Other source(e.g. Excel)

Plug-inXML conversion

1

3 2

Pre-SIEF

SIEF

Data Holders

Pre-Registrants

Data HolderSubmission Procedure

Registrants

EarlyRegistrants

Cefic / Concawe developed standard based on Excel – free of charge for all companies


This slide is copied from ECHA presentation 15 Feb. 2008

Pre-SIEF web page (ECHA REACH-IT system)


Export to SIEF-IT system

Pre-SIEF data are the basis for SIEF-IT system

SIEF participants

Read- across

Data Holders

Designation of SFFSameness

LR Designation

Classification & Labeling

Cost sharingTesting proposals

Dashboard

ECHA Pages(cannot be updated)

Data Availability

Data Holder pages

Data gaps

SIEF Member Pages

Substance description After 1-1-2009

Company

Available data (studies)

Free access

ECHA REACH-IT system – Pre-SIEF

SIEF-IT system

Data export from Pre-SIEF (ECHA REACH-IT system) to SIEF-IT system


SIEFreach – Information Folders

SIEF participants

Read- across

Data Holders

-Designation of SFF-Sameness

-LR Designation

-Classification & Labeling

-Cost sharing-Testing proposals

-SIEF Status page

ECHA Pages(cannot be updated)

-Data Availability

Data Holder pages

-Data gaps

SIEF Pages

Pre-SIEFdata

Substance description After 1-1-2009

-Company

Available data (studies)

Free access

Note: Consider a SIEF as a set of ‘Information pages’ on relevant topics


SIEFreach - SIEF Page composition

4 different Body types, i.e. maintained by:- Synchronisation with ECHA- Maintained by SFF / LR (most pages)- Maintained by SIEF User (Studies pages)- Maintained by Data Holder

Threaded discussion:- Any SIEF LE User who has write access

Attaching documents:- Any SIEF LE User who has write access

SIEF Name, SIEF Nickname, Sub-SIEF Name

Body

Forum

Attachments

Header


From REACH-IT system to SIEFreach

1. SIEFreach - preparation:– Setup Legal Entity structure and create User Accounts

– Legal Entity Group Administrator (First user to sign up for a company):

– Creates Legal Entity Group

– Creates Legal Entities

– Creates User Accounts

2. REACH-IT system - Data transfer:– ECHA Pre-SIEF data is the basis for the SIEF

– Pre-Registrants access ECHA Pre-SIEF web page to view pre-registrants, including Potential Registrants, (Early)-Registrants, Data Holders

– Data transfer from ECHA system to SIEF IT system triggered by a Pre-SIEF participant

3. SIEFreach - SIEF activation:– ‘Handshake’ ECHA data and SIEF LE data

– Assigns Users to SIEFs (allocate to SIEF slot)


Substance

Legal Entity

Legal Entity Group1

2

Legal Entity Legal

Entity Legal Entity

SubstanceLegal EntityLegal

EntityLegal Entity

ECHA REACH-IT system

SIEF


Entity


EntityLegal Entity

SIEFSIEF

4

SIEFreach system1 - Setup your company SIEF structure

(Legal Entity Group, Legal Entities, Administrator, User Accounts)- Data transfer from ECHA- Handshake / activate in SIEFreach- Allocate Users to SIEF / SIEF Role- Collaborate with other SIEF participants

Legal Entity

3

5

Legal Entity

Pre-SIEF 1

Pre-SIEF 3

Pre-SIEF 2

Pre-SIEF …

2

3

4

Pre-SIEF

Legal Entity Group Admin.

(LEGA)

UserAccountUser

AccountUserAccount

SIEF FolderSIEF FolderSIEF Folder

SIEF Folder

E.g. - Substance Sameness- Studies- Data Gaps- C&L

5

Pre-SIEF data

Steps to go through:

From REACH-IT system to SIEFreach


SIEFreach







Pre-SIEF

Administrative Tasks

SIEF Status Page

- User Admin- Security

- Assign Lead Registrant

SIEF Formation

Cost sharing

C&L

Subst. Id. Card

Data Exchange

Maintain Information Pages

SFF* responsibility

Lead Registrant responsibility

* SFF = SIEF Formation Facilitator

Prepare Joint

Submission

Administrative Tasks

SIEF Status Page

Joint Submission Member

Submission

- Discussion Forum - Collaboration Tool- SIEF changes

Registration

SIEF IT system - Overview

Potential Registrants

‘Invited Users Page’

SIEF System

boundary

SIEF system

changes

SIEF Database


SIEFreach – System overview

SIEF updates

• Updates at ECHA system during / after Pre-Registration phase, e.g.:– Name, Address, Contact person– Cancel Pre-registration (inactivate in system – no physical delete)– Late Pre-Registrant– Add Read-across Substances– Add Data Holder

Synchronisation with SIEF by ‘refresh’, triggered by an active SIEF User

• In addition, SIEF updates will be possible in SIEF IT system, e.g.:– Splitting / Merging of SIEFs


SIEFreach – screenshot-1


SIEFreach – screenshot-2


SIEFreach







Fee Payment:– Payment options:

• Credit card (CC) orders and • Purchase Order (PO) / Sales Order (SO) / Invoice process

– Legal Entity Group Admin (LEGA) is contact for PO / Invoice – LEGA sends Purchase order for SIEF participations by Legal Entities – After payment, credit amount is stored at LEG level– For each SIEF participation, credit amount will be deducted– Reporting will provide details on spent amount per Legal Entity

SIEFreach – Invoicing process


SIEFreach – Fee payment

• Fee payment to be paid in order to cover the cost for the system

• ‘One time fee’ for each SIEF participation for 11 yrs.:

• Base fee: 300 € by SIEF / by Legal Entity / Substance

• Payment required to obtain access to SIEF (However, a ‘non paying area’ is available to view limited information)

• Payment mode:

– Credit card (for one SIEF): direct access

– Purchase order / Invoicing: Pay in advance for multiple substances (Credit amount managed by the system)

• ‘Early birds’ – PO before 1 July 2008 (tbc): Discount if Purchase Order >= 3000€

• Discount for SMEs will be reviewed by end 2008

User Role Base Fees

• Pre-registrant

• Additional person for a Legal Entity /SIEF

300 €

150 €

• Registrant • Additional person for a Legal Entity /SIEF

300 €150 €

Invited Expert 150 €

Data Holder 150 €


SIEFreach







Registration

SIEF IT system

Agency

Industry

(Joint Submission) Dossier

Preparation

Pre-Registration / SIEF / Registration process

IUCLID5

ECHA Pre-SIEF data is the basis for SIEF-IT system

Other source(e.g. Excel)

Plug-inXML conversion

1

3 2

SIEF

Data Holders

Pre-Registrants

Data HolderSubmission Procedure

Registrants

EarlyRegistrants


SIEF IT system project

After SIEF:

Registration (Joint Submission):

– Lead Registrant (LR) submits Registration Dossier first – Receives ‘Joint Submission token’ (ticket number)– LR distributes JS token to other JS members– JS members submit their registration dossier

– Dossiers are processed at ECHA (using REACH-IT Workflow system)


Thank you

DI conference – 28 May 2008 (Pre-)SIEF in practice Jack Wille - Cefic.

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Transcript of DI conference – 28 May 2008 (Pre-)SIEF in practice Jack Wille - Cefic.