EU Portal and Database Update
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1 EU Portal and Database Update TOPRA 4 October 2017 Presented by Noémie Manent on 4 October 2017 Committees and Inspections Department An agency of the European Union
2 Table of content EMA Portal and Database status update The detailed functionalities for Sponsors Conclusions 1 EU Portal and Database Update
3 EU Portal and Database Update 2 EU Portal and Database Update
4 Collaborative working The EMA is working collaboratively EUROPEAN COMMISSION EUROPEAN MEDICINES AGENCY MEMBER STATES & ETHICS COMMITEES STAKEHOLDERS - Sponsors - CROs - Health Care Professionals - Patient Representatives 3 to develop systems to implement the regulation EU Portal and Database Update
5 Eu Portal and Database Update key milestones System Release 0.6 UAT dates: 6 Nov 27 Nov 2017 System Release 0.7 UAT Dates: end of Q The audit of the EU portal and database : Q The purpose of the audit is to confirm that the EU Portal and Database have achieved full functionality and the system meets the functional specifications which are defined in the document Functional Specifications of the EU Portal and EU Database to be audited (EMA/42176/2014 Rev.1, Corr.). System Release 0.8 UAT dates: beg of Q EMA MB to endorse the results of the audit EU portal and database Launch: 2019 (actual date to be 6 months after the notice referred to in Article 82(3) of the CT regulation No. 536/2014 is published) 4 EU Portal and Database Update
6 Detailed Functionalities 5 EU Portal and Database Update
7 EU portal and database System interfaces MSs Sponsors CT Portal/EU DB WHO EMA Business Processes User Registration & Security (IAM) User Interfaces CT System Master Data Management (RMS/OMS) CT DB Public DB 6 Data Warehouse (DWH) EU Portal and Database Update Document Management (DMS) EV Human
8 Activities in the system Submit application (CTA dossier) / Address request for information Submission of CSR Submission of Union Control Reports Notification of willingness to be RMS (part I) / Decision on RMS Update of Clinical Trial information (re non substantial modifications) Submit notifications: Start of trial First visit first subject End of recruitment End of trial (in each MS, All MS, Global) Temporary halt & restart Serious Breach, Unexpected event, urgent safety measure Inspection from third country inspectorate Submission of clinical study result (summary and lay person summary) 7 EU Portal and Database Update Applicant of a MA Sponsors General public EMA Commission Member States Search and view CT information System Maintenance Submission of requests for information Notification of the final validation (initial, additional MS or Substantial Modification) Submission final AR conclusion Part 1 and to 2 Part I and Part II Final single decision notification Submission Inspection Information Communication disagreement to part 1 assessment Communication on implementation of corrective measures
9 User management 8 EU Portal and Database Update
10 EU portal and database User management hierarchy A structured top-down approach to maintain the integrity of the system EMA validates High-level administrators (Sponsors, Member States, EU Commission, MAHs) Approves Medium-level administrators (Sponsor Clinical trial and MS national organisation administrators) Approves Assign new role/ct access Amend role/ct access Revoke role/ct access Approve/reject user requests for a role (only applicable to sponsor users) Role allocated to perform activities in the system Regular users Regular users Regular users
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13 Creation of clinical trial applications, responding to RFI, submit trial notification (e.g. trial start) and viewing the clinical trials 12 EU Portal and Database Update
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18 The left inside panel now displays the member states concerned
19 Actions by the user Lock/unlock Left inside navigation Right inside navigation
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22 Verification of the completion of the dossier before submission
23 Confirmation message once the user has clicked submit
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27 The Public View 26 EU Portal and Database Update
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29 Advanced search
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32 Training 31 EU Portal and Database Update
33 CT Programme: Training principles and approach Online training Face - to - face Training colleagues On-going support Details Details Details Details Enable submission of dossier in 1 day Online material: - demo videos, - test environment, - user manuals, - guidance documents - in-system information Tailored training of Lead trainers Provided by training concessionaire 2-3 days for commercial sponsors 1 day for SME s & noncommercial sponsors Lead trainers use knowledge and online material to train colleagues Online material (refer to the Online training section) The EMA provides ongoing support through Webinars, Query management, etc. Targeted at: Targeted at: Targeted at: Targeted at: All stakeholders Large commercial sponsors SME s Primary focus of training Non-commercial sponsors 32 EU Portal and Database Update Member States Large commercial sponsors SME s Non-commercial sponsors All stakeholders
34 Off site and on-site UAT approach 33 EU Portal and Database Update
35 Key Objectives MS & sponsor orgs represented in UAT with on-site testing and off-line testing (37 testers/uat6) Interactive and E2E scenarios Sponsors - MSC Additional features tested Testing date: 6 Nov 27 Nov 2017 with collection of feedback on an on-going basis UAT 6 bugs to be with our developer before 22-Dec EU Portal and Database Update
36 UAT 6 Timeline Key Dates and Information UAT 6 Webinar Details Communication w/c 18-Sep-2017 UAT 6 Off-site Execution 06-Nov-2017 to 27-Nov-2017 UAT 6 Provisional Webinar Dates w/c 16-Oct-2017 EMA Management Board Meeting 13-Dec-2017 to 14-Dec-2017 UAT 6 On-site Execution (and Support) 06-Nov-2017 to 10-Nov-2017 UAT 6 Completion Report Preparation w/c 11-Dec EU Portal and Database Update
37 Conclusions 36 EU Portal and Database Update
38 Conclusions: Harmonisation: One single submission for authorisation of a clinical trial to and for public registration (primary register of clinical trials); Member state collaboration: Facilitate cooperation among MSCs One single decision per Member State; IT maintenance: EMA to maintain and update the IT platforms; Public data and information about medicines, their development and authorisation To generate trust information is available To build confidence I understand what is happening To empower knowledge enables decision-making 37 EU Portal and Database Update
39 For more information: a.eu/ema/index.jsp?cu rl=pages/regulation/ge neral/general_content_ jsp&mid=WC0 b01ac df 38 EU Portal and Database Update
40 Any questions? Further information European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website Follow us
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