IRIS Quick guide to registration

Transcription

1 21 June 2018 EMA/416538/2018 Information Management Division IRIS Quick guide to registration Version Purpose and context Purpose of this Quick Guide Context How to know what registration steps are required How to create an EMA user account Go to the EMA Account Management Portal Complete the online EMA registration form Set up Authentication Questions for your EMA User Account How to find an Organisation ID or create a new one Look up the Organisation ID in the OMS (SPOR Portal) Request for an Organisation to be registered in OMS Request a SPOR Unaffiliated User access role Raise a change request in OMS How to request access to the IRIS portal How to request an Orphan Industry user role How to request an Orphan Industry User Admin role How to access the portal after your role has been approved How to register a new active Substance Check if the Substance is already registered Complete the Substance Request Form Raise an EMA Service Desk request to register a Substance Registration and approval process overviews Registering the first User Admin role for your organisation Registering subsequent users Registering an Organisation in OMS Orphan Industry user roles overview Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 1. Purpose and context 1.1. Purpose of this Quick Guide This Quick Guide has been produced in order to help users of the IRIS Regulatory & Scientific Information Management platform know how to cover the new pre-requisite steps that have to be completed before accessing the IRIS portal or submitting an orphan designation (OD) application. This document is primarily focused on industry stakeholders, but may also be of use to regulatory users Context From 19 June 2018 onwards, organisations seeking to apply to the EMA for a product to be considered for orphan designation will be able to follow a new process. This new process, which will become mandatory after 19 September 2018 for orphan designation, requires the following steps to be completed before any activity relating to an orphan designation procedure can be carried out using the new IRIS Portal: a) Both the Applicant 1 and Sponsor 2 of an orphan designation, or persons acting on their behalf, must have an active EMA user account and must be registered with IRIS user access roles of either Orphan Industry Manager or Orphan Industry Contributor b) The Organisation for which the OD application is being submitted must be registered in the EMA s Organisation Management System (OMS); a) b) Pre-register Substances c) The Substance(s) for which the application is being submitted must be registered and appear on the official EMA list of all substances, the European Union Telematics Controlled Terms (EUTCT) database; c) Pre-register Organisations Request Research Product Identifier (RPI) d) Each new OD application must have a Research Product Identifier (RPI) - the process for requesting an RPI will be covered in the Quick Guide to the IRIS Portal. The instructions in this guide involve visiting 3 different data and user management portals, all of which sit, for data security reasons, outside the EMA website. For this reason, we have provided hyperlinks to each portal which you can click on from this Word document. We have also provided the URL address of each portal so that you can type the URL into your web browser. 1 Applicant : The individual or organisation submitting the application to EMA. 2 Sponsor : The addressee of the European Commission decision granting orphan designation for the medicinal product. EMA/416538/2018 Page 2/27

3 2. How to know what registration steps are required The following table of questions will help you know what steps you need to take. Question Answer Action a) Am I already registered as an Orphan Industry Manager or Orphan Industry Contributor? Yes No You are ready to log into IRIS (See Section 5.3), but first: a) Check that the Authentication Questions for your EMA User Account are set up (See Section 3.3); and b) Check each active substance contained in your research product is listed as Current on the EUTCT List (See Section 6.1). Request a role with affiliation to the organisation on whose behalf you will be acting for the orphan designation (See Section 5.1). To do this you must have an active EMA user account and know the Organisation ID for that organisation. b) Do I have an active EMA user account? No Self-register with EMA as a new User (See Section ). Yes Log into the EMA Account Management portal and make sure that you have set up your Authentication Questions (See Section 3.3). c) Do I know the Organisation ID for the organisation on whose behalf I will be acting for the orphan designation? d) Have Orphan Industry User Admin roles been set up for the organisation on whose behalf I will be acting? e) Is each of the active substances (in the research product) listed as Current on the EUTCT List? Don t Know Yes No No, and my Organisation is not registered Yes No Don t Know No Yes Try logging in with your address and it will tell you if you have an existing account (See Section 3.1). Make a note of the Organisation ID so that you can use it when requesting an Orphan Industry user access role. Look up your organisation in the EMA Organisation Management System (OMS) (See Section 4.1) and find the Organisation ID. This means that you need to: a) Request user access to OMS (if you do not already have it); and b) Raise a request to have your organisation registered (See Section 4.2). Carry on with requesting the role you need, e.g. Orphan Industry Manager / Orphan Industry Contributor (See Section 5.1). Before you request a role, ensure that at least 2 people from the organisation get set up as Orphan Industry User Admin (See Section 5.1). If no Orphan Industry User Admin has been set up all role requests will be automatically rejected. Go to the EMA s EUTCT portal and look up each substance to see if it is listed with a status of Current (See Section 6.1). Substances listed with any other status (e.g. provisional or non-current ) cannot be selected in the IRIS portal. Raise an EMA Service Desk request for the substance to be included in the EUTCT (See Section ). No action. The substance(s) will appear in the portal drop-down lists. EMA/416538/2018 Page 3/27

4 3. How to create an EMA user account In order to self-register for using the IRIS portal, you need to have an active EMA user account. If you have access to any of the following systems that means you have an active EMA account: SPOR, Eudralink, EudraCT Secure, service desk portal, European union telematics controlled terms (EUTCT), meeting management system (MMSe), managing meeting document system (MMD), EudraVigilance data analysis system (EVDAS), EudraPORTAL, European Union good manufacturing and distribution practices database (EUDRAGMDP), paediatrics records application (PedRA), SIAMED business intelligence dashboard (BI DASHBOARD), corporate GxP database (CORPGXP), European pharmacovigilance issues tracking tool (EPITT) or periodic safety update repository (PSUR repository). If you are still not sure if you have one, go to the EMA Account Management Portal and click on the link below the Password box: Not sure if you have an EMA account?. To create a new account, follow the instructions below Go to the EMA Account Management Portal First navigate to the Login window for the EMA Account Management portal. To do this, you can: EITHER: Click on the following link: EMA Account Management portal; OR: From your web browser, type into the search bar and hit return Complete the online EMA registration form From the EMA Account Management Login window: 1. Click on Create a new EMA account ; 2. Complete the EMA Self-service Registration Form ; Once the self-registration request has been approved, an automatic notification will be sent to the address that you provided when you completed the registered form. EMA/416538/2018 Page 4/27

5 3.3. Set up Authentication Questions for your EMA User Account If the Authentication Questions for your account are not set up, you will have to raise an EMA Service Desk request every time you need to re-set your password. To check if these are set up, or to change them, carry out the following steps. 1. Login to the EMA Account Management portal on 2. Go to the top right corner of your screen and click on your profile name; 3. Click on Preferences ; 4. Click on the Edit Authentication Questions link at the bottom of the page; 5. Set up or update your Authentication Questions; 6. When you have finished entering your questions and answers, click on the Save button. EMA/416538/2018 Page 5/27

6 4. How to find an Organisation ID or create a new one In order to self-register for using the IRIS portal, you will need to provide the Organization ID for the organisation on whose behalf you will be acting for the orphan designation. You can find the Organization ID in the EMA s Organisation Management Services (OMS) section of the EMA SPOR 3 Portal. On the EMA YouTube channel, emainfo, there is a video that gives an overview of OMS. To find the video, either click on the following link or search on YouTube for: SPOR Learning Module: OMS01 - Overview of OMS Look up the Organisation ID in the OMS (SPOR Portal) 1. Go to the EMA 'Referentials and organisations' web page on the EMA website and click on the SPOR portal or type into your web browser; 2. Click on Organisations in the top (white) menu bar; 3. When the SPOR Organisations Management System web page opens, click on the Organisations button in the lower (dark blue) menu bar; 3 The SPOR Portal and the data management processes that sit behind it have been put in place to ensure that the highest quality of data (relating to Substances, Products, Organisations, and Referentials) is available to support EU regulatory processes carried out by EMA. EMA/416538/2018 Page 6/27

7 4. Type the name of the organisation you wish to find in the Organisation name box and hit Search (button on bottom right of the page); 5. If the organisation does not appear in the list after hitting search, then follow the instructions in the next section (4.2 Request for an organisation to be registered in OMS ). 6. If the organisation appears in the list, this means that it is already registered and will appear on the dropdown list when you are requesting your IRIS user access role (See Section 5 How to request access to the IRIS portal ); 7. Look in the Organisation ID field (left hand column) and make a note of or copy the ID number onto your clipboard to use when you request your IRIS portal role. EMA/416538/2018 Page 7/27

8 4.2. Request for an Organisation to be registered in OMS It is the responsibility of all external organisations to ensure that any data held in SPOR 4 about their organisation is accurate and up to date. For that reason you need to have user access to the SPOR portal before you can request for a new organisation to be registered in the Organisations Management Services (OMS) section of SPOR. So, if your organisation is not listed in OMS and you do not have user access to SPOR, you need to carry out the steps shown below Request a SPOR Unaffiliated User access role 1. Log into the EMA Account Management portal on ; 2. Click on Manage My Access ; Name of User 3. Type SPOR Unaffiliated in the search bar a box describing the SPOR Unaffiliated User Name of User access role will appear; 4 SPOR refers to the EMA data management processes that have been put in place to ensure that the highest quality of data (relating to Substances, Products, Organisations, and Referentials) is available to support EU regulatory processes carried out by EMA. EMA/416538/2018 Page 8/27

9 4. Click on the tick button to select the SPOR Unaffiliated User access role; 5. Click on Add Access ; 6. Click Review Name of User Name of User 7. Click Submit. Requests for the role of SPOR Unaffiliated User do not require an approval step and are granted automatically by the EMA Account Management system. Your request should therefore be approved almost immediately. To check that your role request has been approved, go to the SPOR portal and try logging in (click on the Login button and enter your EMA User Account username and password). When your request for the SPOR Unaffiliated User role has been approved and you have logged in to the OMS portal you can raise a Change Request in OMS to have your organisation registered Raise a change request in OMS To raise a change request for a new organisation in OMS, log in as a SPOR user and run a search for the organisation. When the No results found message comes up, click on the Register New Organisation button to open the change request form. Detailed steps for doing this are as follows: 1. Go into the SPOR portal ( ); 2. Click on the Organisations tab in the top menu; 3. Click on the Login button (top right of your screen); EMA/416538/2018 Page 9/27

10 4. Enter your EMA Account username and password; 5. Once logged in, click on blue Organisations button in the lower (dark blue) menu; 6. Search for the new organisation; Name of User 7. When the No results found message comes up, click on the Request New Organisation button that appears in the bottom right of the screen; 8. A change request form will appear. Complete this form and submit the request. EMA/416538/2018 Page 10/27

11 The standard response time for a request to register a new organisation can be up to 5 working days. When your organisation has been successfully registered, you will receive an with an Organisation ID code, confirming the successful inclusion of the Organisation in the OMS dictionary. For more detailed instructions on how to use this Change Request form, please refer to section 8.2 Change request process general rules on pp of the OMS web user manual (Version 1.0, 7 th July 2017). This can be found by clicking on the Help tab in the Organisations page of the SPOR portal ( ) as shown in the screenshot below. Further information on the types of changes you can request in OMS is provided in Section 8 Request new organisation, new location or request a change in organisation or location on pp of the OMS web user manual (Version 1.0, 7 th July 2017). If you prefer instructions in video format, you can watch the SPOR Learning Module: OMS03 - Working with OMS Change Requests video on the EMA Youtube channel. The section on requesting a new organisation starts about 6 minutes into this 25 minute video (06:15 > 09:30) and shows an on-screen run through of the process with voiceover commentary in English. EMA/416538/2018 Page 11/27

12 5. How to request access to the IRIS portal In order to use the IRIS portal to carry out any activity related to an orphan designation procedure, you need to have been granted one of the following roles for the organisation on whose behalf you will be acting: Orphan Industry Manager Orphan Industry Contributor When you request one of these roles, the organisation for whom you are requesting them must have someone who has been granted an Orphan Industry User Admin role, whose job it will be to approve your request. EMA recommends that each organisation have at least 2 people with Orphan Industry User Admin roles to ensure that user role requests are not delayed in the event of absence. When a request is made for one of the user roles, the Orphan Industry User Admin for the organisation to which your role request relates will be notified automatically by and (one of them) will carry out the review and approval of your self-registration request. IMPORTANT NOTE: The first Orphan Industry User Admin must be set up before ANY other users try to request access to the IRIS Portal. If this has not been done, ALL requests for the roles of Orphan Industry Manager and Orphan Industry Contributor will be automatically rejected. Subsequent requests for an Orphan Industry User Admin role will be approved by the first person who was granted an Orphan Industry User Admin role How to request an Orphan Industry user role As explained earlier, before you can request an Orphan Industry role (for access to the IRIS portal), you need three things: An EMA User Account (see Section 3. How to create an EMA User account ); The Organisation ID for the organisation on whose behalf you will be carrying out activities in the portal in this role (see Section 4.1 Look up the Organisation ID in the OMS (SPOR Portal) ). For example, you could be employed by a consultancy but requesting access as an Orphan Industry Manager to create an OD submission on behalf of Pfizer Belgium. In which case you would need the Organisation ID for Pfizer Belgium; The knowledge that at least one Orphan Industry User Admin has been set up for this organisation if that has not been done your role request will be automatically rejected. Once these three things are in place, you can carry out the steps listed below. EMA/416538/2018 Page 12/27

13 1. Log into the EMA Account Management portal on 2. In the EMA Account Management home screen, click on Manage My Access ;Orphan Name of User 3. In the Manage My Access screen, type the first part of the role name you wish to request in the Search Access bar. This brings up a list of roles for you to select; 4. Find the role you need to request and to select it click on the tick button to the left of the role (the screenshots below show Orphan Industry Contributor as an example); 5. Click on the Add Access bar; Name of User 5 4 EMA/416538/2018 Page 13/27

14 The role you selected (in this example, Orphan Industry Contributor ) should now have a green tick and a green box saying Add 1 should appear above that role description; 6 6. Click Review and a confirmation page will appear in which you can make additional changes if required; 7. Click on Submit. 7 EMA/416538/2018 Page 14/27

15 8. The following screen will appear to take you to the form where you can input the appropriate Organisation ID ; Unless you provide an Organisation ID, your role request cannot be completed. 9. If you wish, you can choose to defer completing the process and save your draft request. To do this, Click Later and the request form will appear as a pending task on your EMA Account Management home page, listed under Forms / Latest Forms for you to complete later; Name of User EMA/416538/2018 Page 15/27

16 10. If you have your correct Organisation ID, then click on Complete form 11. In the organisation affiliation form that opens up, paste or type your Organisation ID in the box labelled Organisation and enter your EMA user account password; Click OK and your request will now go to the approver. If you have requested an Orphan Industry Manager or Orphan Industry Contributor role, the approver will be an Orphan Industry User Admin from the organisation you selected in your request. EMA/416538/2018 Page 16/27

17 If you are the first person to request an Orphan Industry User Admin role for an organisation, you will need to make a note of your Request ID and raise an EMA Service Desk Request quoting the Request ID and attaching the documentation specified. For full instructions on how to do this, please refer to section 5.2 How to request an Orphan Industry User Admin role EMA will then carry out some checks relating to proof of identity and employment in order to be able to approve the request. When your request has been approved, you will be sent an automatic notification to the address that you provided when you created your EMA User account How to request an Orphan Industry User Admin role Before you can request an Orphan Industry User Admin role, you need three things: An EMA User Account (see Section 3. How to create an EMA User account ); The Organisation ID for the organisation on whose behalf you will be approving roles for people to carry out activities in the portal (see Section 4.1 Look up the Organisation ID in the OMS (SPOR Portal) ); A completed copy of the Orphan Industry User Admin Affiliation Template Letter ready to upload, as proof of authority to represent the organisation (see letter at the end of this section). Once you know these three things are in place, you can carry out the steps listed below. Please note that steps 1 to 10 below, are the same as the steps described in the previous section, but they have been included here as well in case this section is being read in isolation. 1. Log into the EMA Account Management portal on EMA/416538/2018 Page 17/27

18 2. In the EMA Account Management home screen, click on Manage My Access ; Name of User 3. In the Manage My Access screen, type the first part of the role name you wish to request in the Search Access bar. This brings up a list of roles for you to select; 4. Find the role you need to request and click on the tick button to the left of the role; Name of User Click on the Add Access bar; 6. The role you selected should now have a green tick and a green box saying Add 1 should appear above that role description (see screenshot below) - now click Review EMA/416538/2018 Page 18/27

19 7. When the confirmation page appears, click on Submit you may have to wait serval seconds while the system is processing your request; 7 8. A dialogue box will then appear saying More Info Needed, giving you the option to either click Later (if you have not yet looked up the Organisation ID), or to carry on with the process so if you already have your Organisation ID, click Complete Form ; 8 9. The Complete Work Item window will then open up asking you to provide the Organisation ID for the organisation on whose behalf you will be carrying out the role you are requesting enter the Organisation ID and your EMA User Account password; Click OK ; 10 EMA/416538/2018 Page 19/27

20 If you are the first person to request an Orphan Industry User Admin role for the Organisation ID that you have entered, you will now need to make a note of your Request ID and raise an EMA Service Desk Request quoting the Request ID and attaching the documentation specified. 11. To raise a request:click on the following link to the EMA Service Desk portal; 12. Click on Service Desk ; 13. Click on "Request a Service; 14. Select "Access, permission, content updates and password requests"; In the online form, enter the following information: Subject: Type Request for Orphan Industry User Admin role followed by your Request ID; Software: Type IRIS ; Description: Type Please refer to Access Management Request: followed by your Request ID; Attachment: Attach your completed Orphan Industry User Admin Affiliation Template Letter here (To find the template, visit the EMA Service Desk, type orphan into the search bar and click on the item entitled Q/A Orphan industry user administration affiliation template Click on the Create button. Within 5 working days, you will receive an automated notification by that your role has been approved. This assumes that all of the information and documentation that you provide is accurate, complete and that your request is valid. EMA/416538/2018 Page 20/27

21 5.3. How to access the portal after your role has been approved In order to access the IRIS portal, carry out the following steps: 1. Click on this link to the IRIS portal (or type the following URL into your web browser - this takes you to the landing page of the IRIS Portal: 2. Click Sign In (top right of your screen) and then click on the blue Azure ID button; surname_a@id.ema.europa.eu 3. In the Pick an account window, EITHER: surname_a@id.ema.europa.eu a. click on use another account your EMA username in the first box followed for example, if your EMA username is surname_a, type in surname_a@id.ema.europa.eu ; OR b. if this account name already appears in in the Pick an account list, simply click on it; 4. In the first of the sign in boxes, enter your EMA Account username followed by the and then type your EMA Account password in the box below that; Sign in with your EMA Account followed surname_a@id.ema.europa.eu 5. Click Sign In this will take you to the IRIS home page, where you can start to use the surname_a@id.ema.europa.eu EMA/416538/2018 Page 21/27

22 6. How to register a new active Substance To create a submission for orphan designation, the active substance(s) in the product must be already included as a current term in the EMA list of all substances known as the the European Union Telematics Controlled Terms (EUTCT) Substance list Check if the Substance is already registered Before beginning your application, you can search the EUTCT list, to see whether the active substance is already included as current. To find the EUTCT list either type eutct.ema.europa.eu into your internet browser or click the following link to the EUTCT Welcome Page. Click on Guest user access to EUTCT (in the bottom right hand corner of the Welcome Page). Then, in the next window click on Substance in the List Name column. Alternatively, when you start to create a submission for orphan designation in the portal you can simply see if your substance appears in the drop-down list. If it appears you can select it and carry on with creating your submission in the portal. Scenario A: The substance is ALREADY registered If the substance appears in the EUTCT list, with the word Current in the Status column (on the right hand side of the table), it means it is registered with the EMA as an approved term, and is therefore valid for inclusion in a submission for orphan designation. 5 It is planned to move the list and the process to the new Substance Management Services (SMS, part of SPOR) in the near future, at which time this guidance will be updated. At that point, it will be necessary for the user to be affiliated to an Organisation in the SPOR OMS in order to be able to send a request for inclusion of a new active substance in the SPOR SMS. EMA/416538/2018 Page 22/27

23 Scenario B: The substance is NOT registered Your substance is not valid for inclusion in a submission for orphan designation if any of the following are true: a) The substance does not appear in the portal dropdown list; b) The substance does not appear on the EUTCT list; c) The substance appears on the EUTCT list, but with the word Nullified, Provisional or Non-Current in the Status column (see screenshot). If any one of a), b) or c) is true, you will need to register the substance before you can use the portal to create a submission for orphan designation of a product containing this substance. To register a substance, there are 2 simple steps for you to carry out: 1. Complete the Substance Request Form below; 2. Raise a request, via the EMA Service Desk portal, for the substance(s) to be included in the EUTCT list Complete the Substance Request Form You will need to have a completed copy of the Substance Request Form ready to attach to the EMA Service Desk Request that you raise. This form can be found by typing Substance into the search bar in the landing page of the EMA Service Desk; clicking on the Help item entitled How to request the insertion of substances for Orphan Designation and then scrolling down to and clicking on the embedded Excel spreadsheet (see screenshots below). Complete the form and save your own copy. EMA/416538/2018 Page 23/27

24 6.3. Raise an EMA Service Desk request to register a Substance To access the EMA Service Desk portal you can: EITHER Click on the following link to the EMA Service Desk portal; OR Enter the following in your internet browser search bar and hit return : servicedesk.ema.europa.eu/jira/servicedesk/customer/portals. Then carry out the following steps: 1. Click on "Service Desk"; 2. Click on "Request a Service"; 3. Select "Access, permission, content updates and password requests"); 4. In the online form, enter the following information: Subject: Type Request for substance to be registered for orphan designation ; Software: Select EUTCT (from the drop-down list); Description: Indicate the date when you are planning to make your submission; Attachment: Attach your complete Substance Request Form here; 5. Click on the Create button. Within 5 working days, you will receive an automated notification by that your substance has been registered. This assumes that all of the information and documentation that you provide is accurate, complete and that the substance is valid for registration. The substance will then appear in the drop-down list on the portal, when you are creating your submission for an orphan designation. EMA/416538/2018 Page 24/27

25 7. Registration and approval process overviews 7.1. Registering the first User Admin role for your organisation 3b. Existing users go straight to login EMA Account Management Portal First-time Portal users need to setup their security questions EMA Servicedesk 1. New users need to selfregister using the EMA Account Management Portal 2. Complete the user registration process 3a. Login to EMA Account Management Portal with your account credentials 4. Request Orphan Industry User Admin role 7b Non affiliated users go straight to submit request. 8. Raise EMA Service Desk request. Attach supporting documents and add the access request number. 7a. Submit access request for User Admin role. Complete additional information required, including the Organisation ID. Note the access request reference number. 6. If required, follow OMS subprocess to add/update missing organisation details. 5. Locate organisation in OMS and make a note of the Organisation ID. OMS Portal 9. EMA processes User Admin request 10. User Admin role granted and organisation affiliation confirmed 11. Notification by that User Admin role has been approved 7.2. Registering subsequent users 3b. Existing users go straight to login EMA Account Management Portal First-time Portal users need to setup their security questions 1. New users need to selfregister using the EMA Account Management Portal 2. Complete the user registration process 3a. Login to EMA Account Management Portal with your account credentials 4. Request Industry User role Company process 8. Industry companies are responsible for defining their own criteria for approving User requests 7a. Submit Additional information. Note the Access Request number 5. Locate organisation in OMS to affiliate the User role OMS Portal 9. Existing Industry User Admin processes requests for additional Industry Users 10. Industry User role approved and organisation affiliation confirmed 11. Notification by of Industry User role request having been approved EMA/416538/2018 Page 25/27

26 7.3. Registering an Organisation in OMS 1. Submit SPOR role access request for SPOR Unaffiliated User 2. Gather additional information required to support organisation request 3. Search OMS for organisation ID 4. If not listed, create a New Organisation Request in OMS and submit it for approval 7. Organisation data ready to use for User affiliation or as Contact details 6. The requestor will be notified of the new organisation ID 5. EMA Data Stewards review and approve requests for new organisations EMA/416538/2018 Page 26/27

27 8. Orphan Industry user roles overview For organisations, there are three Orphan Industry user roles Orphan Industry User Admin Orphan Industry Manager Orphan Industry Contributor In future, your organisation will only have to provide documentation to EMA when requesting the first Orphan Industry User Admin role Activities Orphan Industry User Admin Orphan Industry Manager Orphan Industry Contributor Approve Orphan Industry Users Create/delete draft applications Allocate contributors to an application Edit /view specific* applications Submit / withdraw specific* applications *Users will only see those applications which they created as Manager, or for which they were named as a Contributor by another Manager. EMA/416538/2018 Page 27/27