Introduction to testing

Introduction to testing

R4BP 3.10 and SPC editor key users testing Introduction to the new features 25 September 2017 Roberto Gilioli European Chemicals Agency Overview 1. Agenda of the day 2. Objectives and scope of the testing

3. Perform the testing and report feedback 4. Items for implementation in 2018 Agenda of the day Agenda 25 September 2017 09:30 10:30 Introduction to the testing exercise

10:30 10:45 Coffee break 10:45 13:00 Testing of R4BP 3.10 beta 13:00 14:00 Lunch break

14:00 15:30 Testing of R4BP 3.10 beta 15:30 15:45 Coffee break 15:45 17:00

New features for 2018 and wrap up 17:00 END After-hour plans 18:00 - Informal get-together

4 Objectives and scope of the testing Objectives Get familiar with the new features of R4BP 3.10 Test the usability Provide early feedback Discuss the scope of R4BP 3 development in 2018

6 Main features in R4BP 3.10 User interface improvements Communication improvements Mutual recognition of same biocidal products Synchronisation of NA-APP and NA-MRP Redefinition of active substance Submission of information post approval of active substance

7 User interface improvements Relation diagram 9 More features of the diagram Clicking on any rectangle or circle will open in a

new tab the corresponding case or asset details. The case type is reported in each rectangle Circle's border is dotted: the asset is a family member Label of a circle not bold: the current user cannot access the asset details No case type number in the circle: it is migrated! 10 Enhanced case and assets details export

Fields exported in worksheet:

Case number Product/Substance name Trade name(s) Active substances Product type(s) BAS number

EC number CAS number IUPAC name Case type Dossier UUID Evaluating authority

Submission date Case status Completed on Target Asset number Implementing regulation decision Decision date Case owner name Asset owner name 11

Search cases/assets also by company name 12 New filter criteria Assets generated from NA-MRS, NA-MRP, NA-BBP and NA-BBS 13

More multi-select fields For cases and assets 14 Calendar selection for reply by date No more counting of days 15

Additional improvements Possible to select multiple PTs per single use in the SPC editor Improved message for SPC format error Fixed the Invalid XML SPC error when pasting text with special characters in the editor No more automatic message sent to applicant when a case is resumed by ECHA 16

Improved communication Better search and archive! 18 Case owners can initiate a communication with evaluating CAs 19

Process flow enhancements Mutual recognition of SBP professional & public uses public uses (25 ppm)

MR professional & public uses MR SBP MAC professional & public uses

MR public uses (25 ppm) public uses (25 ppm) 24

Mutual recognition of SBP professional & public uses public uses (25 ppm) MR

professional & public uses MR NOW PERMITTED! SBP MAC

professional & public uses MR public uses (25 ppm) public uses (25 ppm)

24 One LE can hold more than one NA (SBP) per product per market area As a consequence are allowed: Multiple Mutual recognitions of SBP in the same market where the reference product already holds a Mutual recognition Multiple NA (SA, UA) in the same market for the same product

Multiple MR having the same reference NA Multiple SA or UA (or both) for the same product 23 Synchronisation of NA-APP and NA-MRP Agreement scenario 24

Synchronisation of NA-APP and NA-MRP Disagreement scenario 25 Synchronisation of NA-APP and NA-MRP New task items

26 Synchronisation features "Evaluate and draft PAR & SPC(s) (EVP) by rMS has to be concluded within 365 days. "Agree on SPC" (ASP) must be concluded within 90 days. If cMS does not respond in 90 days, silent agreement is assumed! rMS should grant authorisation first!

27 Streamlined notifications (SN-NOT) Notify one or more members of a family in one wizard

Notify one or more single products in one wizard 28 New SPC component for upload 29

Select assets 2 1 3 30 Redefinition of an active substance

31 Within the Review Programme Supported: One substance redefined in another one One substance redefined in more than one substances Many substances redefined in one substance 32

Change (correct) Active substance 33 Additional features Scientific data update after active substance is approved (AS-UPD), (AN-UPD) To Be Completed The evaluation timer for CAs in SA-APP after provision of further documentation by the applicant is restarted and set to 90 days

Automation of ECHA processes Increased capability for data corrections 34 How to perform the testing and report feedback Testing environment (Trasys) Trasys testing environment will be used today Instructions on how to access are available in

your laptop Customised data are available for testing Feedback form to be filled in! 36 Plans for 2018 Features to be implemented in 2018 New case types

Article 95 list amendments Active Substance cancellations Grouped NA-MIC and NA-MAC process synchronisation Workflow enhancements Support amendments or cancellations of markets where Union Authorisations are applicable Union Authorisation in EEA countries Enhancement of efficiency of internal ECHA

processing of dossiers 38 Features to be implemented in 2018 User interface improvements: Further enhancement of the search functionality, (remember filter, search for reference MR, etc.) More information on the case available on process steps details (i.e. AS already applied for) Allow amendments of actions done by mistake

Communication enhancements: further flexibility to the messaging system (cc feature) Improvements to the SPC editor compare feature Find and replace text in the SPC editor 39 Features to be implemented in 2018 Performance improvements Preparations for Brexit:

Possibility to transfer reference case responsibility from one MS to another. Content check in applications (e.g. flag applications for Annex I of Active substances not eligible) Further improve error messages and alerts from the system 40

Thank you! [email protected]

Recently Viewed Presentations

  • Great Depression - MIT

    Great Depression - MIT

    Great Depression 21H.102 October 17, 2005 Great Depression 21H.102 October 17, 2005 WPA, Bronx bridge WPA mural art, "Construction of a Dam" (by William Gropper) Federal Theater Project, "One-Third of a Nation," 1938 Marian Anderson at the Lincoln Memorial, Easter...
  • Antimatter - 123seminarsonly.com

    Antimatter - 123seminarsonly.com

    A picogram is a trillionth of a gram. All of the antiprotons produced at CERN in one year would be enough to light a 100-watt electric light bulb for three seconds. All of the antiprotons produced at CERN in one...
  • Courtesy: www.carlprosper4nugs.yolasite.com Contracts Law Consideration, Intention to Create

    Courtesy: www.carlprosper4nugs.yolasite.com Contracts Law Consideration, Intention to Create

    Balfour v. Balfour: ... (Act 137) - "goods suitable to the condition in life of the person to whom they are delivered and to his actual requirements at the time of delivery" e.g., educational materials, medical services, shelter and food,...
  • Test Drive - Campus Docent Sant Joan de Déu

    Test Drive - Campus Docent Sant Joan de Déu

    Centre Salut Mental d'Adults (Barcelona) Preparació per les PAU BIOLOGIA CIÈNCIES DE LA TERRA QUÍMICA * franja de migdia (14-15h) Sortides professionals: Tècnic en documentació sanitària Tècnic en codificació Tècnic d'arxius de Centres Sanitaris Tècnic auxiliar d'investigació Capacitats clau Els...
  • Review of Data Centre Network, Databases and Data Evalaution

    Review of Data Centre Network, Databases and Data Evalaution

    The first RCM was held 26-28 Sep 2012. Comments (BJB): ... Roadmap to the internationally agreed standard data library for AM/PSI data for fusion applications. Phase 1: Establishment of infrastructure for evaluated data library. IAEA A+M Unit: Development of databases...
  • Monday Tuesday Wednesday Thursday Friday Saturday Sunday 14

    Monday Tuesday Wednesday Thursday Friday Saturday Sunday 14

    5.6g of iron react with 24.0g of bromine to form iron bromide. Calculate the empirical formula of iron bromide. [3 marks] 26th Mar. Describe three different ways in which electromagnetic radiation with frequencies greater than that of visible light can...
  • Lesson A3-3: Using Power Tools - Agriculture is our

    Lesson A3-3: Using Power Tools - Agriculture is our

    Portable disc grinder/sander/buffer Rotating disc that is used for work where the material to be ground, sanded, or buffed is too large or heavy to move to a stationary tool Secure the work, hold tightly to the tool, wear eye...
  • PART C SSIP: - OSEP Ideas That Work

    PART C SSIP: - OSEP Ideas That Work

    PART C SSIP: Phase I Strategies to Improve Social-Emotional Outcomes ... Kansas will see improvement in the early childhood positive social-emotional skills outcome for Medicaid-eligible children exiting tiny-k programs with skills at age-appropriate levels ... we need to be just...