Future functionalities

7th BPR IT User Group Meeting

Jan Weber

R4BP 3 Product Manager

European Chemicals Agency

9 November 2015

2

• Vision

• Project

The road ahead

Vision: 3 years

Non-functional • IUCLID 6 compatibility etc.

Functional • Meta SPC • Remaining case types • Review Programme Regulation • Same Biocidal Product Regulation • Grouped submission enhancement • Search engine for biocidal products’ data • Address reporting needs • Dissemination

Meta-SPC

Amendments SBP

regulation

>50 processes

IUCLID 6

Review Programme Regulation

Dissemination

Reporting

Search

3

Vision: 3 years

• Case merging & case transfer • Automate NA-NPF & SA-NPF workflows • Active substance case merging • Active substance management • Active substance: support multiple applicants • Simplify authorisation enhancements • Create Article 95 list in R4BP for dissemination • Comparative assessment tool • Delegation and Nomination enhancement • New case type: Automated invoices • Automation of IUCLID related business rules • Improve search case/asset functionality

Meta-SPC

Amendments SBP

regulation

>50 processes

IUCLID 6

Review Programme Regulation

Dissemination

Reporting

Search

4

Benefits

IND & MSCA costumers

• Complete legislative implementation (case types)

• Efficiency & efficacy gains

• Introduce Meta SPC

Authorities & COM

• Facilitate sustainable use: comparison tool

• Data mining to support product use monitoring

ECHA

• Backlog reduction

• Enable further automation submissions processing

5

Project: 1 year

• IUCLID 6

• Meta SPC

• Review Programme

• Amendments to the

Same Biocidal Product Regulation

• More case types Meta-SPC

Amendmts SBP

regulation

>50 processes

IUCLID 6

Review Programme Regulation

6

How we work

• Scope setting / budget

• Collecting business needs

• Prioritisation

• Analysis

• Encoding

• Testing

• Release

7

Project(s) Plan 2016

2016 2015

Start End

Nov Jan Feb Mar Apr Jun July Aug Sep Oct Dec Oct Nov May

RELEASE 2 • IUCLID 6.1 adaptation • Review Programme

RELEASE 1 Technical Upgrade

RELEASE 3 • Meta SPC • SBP adaptation & SPB for UA

• Oracle 12c • JDK 8 • Latest Wildfly • Activiti engine? • Redhat • Invoicing NG tech.update incl IDM integr & RBP adapt

Non Functional Req.

8

2016 2015

Start End

Nov Jan Feb Mar Apr Jun July Aug Sep Oct Dec Oct Nov May

RELEASE 2 • IUCLID 6.1 adaptation • Review Programme

RELEASE 1 Technical Upgrade

RELEASE 3 • Meta SPC • SBP adaptation & SPB for UA

• Oracle 12c • JDK 8 • Latest Wildfly • Activiti engine? • Redhat • Invoicing NG tech.update incl IDM integr & RBP adapt

Non Functional Req.

Maintenance

Data Correction

Project(s) Plan 2016

9

2016 2015

Start End

Nov Jan Feb Mar Apr Jun July Aug Sep Oct Dec Oct Nov May

RELEASE 2 • IUCLID 6.1 adaptation • Review Programme

RELEASE 1 Technical Upgrade

RELEASE 3 • Meta SPC • SBP adaptation & SPB for UA

• Oracle 12c • JDK 8 • Latest Wildfly • Activiti engine? • Redhat • Invoicing NG tech.update incl IDM integr & RBP adapt

Non Functional Req.

Maintenance

Data Correction

ePIC maintenance releases

ECHA Account Management maintenance releases

IUCLID 6.1

REACH-IT 3.0

Project(s) Plan 2016

10

2016 2015

Start End

Nov Jan Feb Mar Apr Jun July Aug Sep Oct Dec Oct Nov May

RELEASE 2 • IUCLID 6.1 adaptation • Review Programme

RELEASE 1 Technical Upgrade

RELEASE 3 • Meta SPC • SBP adaptation & SPB for UA

• Oracle 12c • JDK 8 • Latest Wildfly • Activiti engine? • Redhat • Invoicing NG tech.update incl IDM integr & RBP adapt

Non Functional Req.

Maintenance

Data Correction

ePIC maintenance releases

ECHA Account Management maintenance releases

IUCLID 6.1

REACH-IT 3.0

Business Analysis

Testing Testing Testing

Project(s) Plan 2016

11

2016 2015

Start End

Nov Jan Feb Mar Apr Jun July Aug Sep Oct Dec Oct Nov May

RELEASE 2 • IUCLID 6.1 adaptation • Review Programme

RELEASE 1 Technical Upgrade

RELEASE 3 • Meta SPC • SBP adaptation & SPB for UA

Business Analysis

Testing Testing Testing

Testers needed

Feedback needed

Project(s) Plan 2016

12

13

Analysis

• IUCLID 6

• Meta SPC

• Review Programme

• Amendments to the

Same Biocidal Product Regulation

• More case types

13

Meta-SPC

Amendmts SBP

regulation

>50 processes

IUCLID 6

Review Programme Regulation

14

Analysis IUCLID 6

Presentation by ECHA IUCLID team

15

Analysis Meta SPC

Family

Meta

Member

16

Analysis Meta SPC

• Family template

• Single notification template

• Same single product template

• Import XML (old family to new)

• Preview XML

• Additional features (compare/translations/ menu)

• Impact analysis

17

18

19

20

21

Same Biocidal Product Regulation

Product family member

Union Authorisation

SBP NA

Analysis Same Biocidal Product Reg.

Sequence

Parallel

Union Authorisation UA

NA-BBS

NA-BBP

Product Family member NA

NA-BBS

NA-BBP

Product Family member SA

SA-BBS

SA-BBP

+ Delegation (initiate BB case) & Nomination (e.g. consultant)

BB = ‘back-to-back’

22

23

Analysis Review Programme

• Participants management AS-EVA

• Change Participants PA-CHG

• Declaration of interest to notify DI-SUB

• Notification take over the role of participant RP-NOT

• Cancellation of active substance AS-NLS

• Rejection flow AS-EVA

• AS case merging

R4BP 3.5: Union Authorisation

• Notification of product in product family

• Same biocidal product (authorised)

• Amendment

• Transfer

• Cancellation

• Administrative change on request

• Minor & major change on request

• Approval of an active substance in an additional PT

24

Get involved

• Analysis

• Testing

• Timing tbd

• Volunteers?

25

Thank you

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jan.weber@echa.europa.eu