PSUR Repository Webinar On API: Q&A On Preparedness For Usage

PSUR RepositoryWebinar on API: Q&A on Preparedness for Usage21 May 15Chairs: Joris Kampmeijer (MEB) and Evdokia Korakianiti (EMA)An agency of the European Union

Agenda#TopicRespTimeChairs101Welcome and objective of the webinar2Overview of the PSUR RepositoryIR153The Post-audit functionalitiesOS104Overview of the APICEE205Expected impact of the API on your IT infrastructureOS and CEE106Expected impact of the API on your business processesIR107Feedback from the surveyIR and OS108Q&AAll309Proposed strategy to support NCAs in dealing with the impact of using the APIWrap-upChairs101

1. Welcome and objective of the webinar(1/1)Objective of today’s meeting:As part of the EMA’s commitment to assist NCAs inpreparing as much as possible for the usage of theAPI and integrating the usage of the API in yourbusiness processes, this webinar will address bothtechnical and business-process related aspects.

2. Overview of the PSUR Repository#(1/11)TopicRespTime1Welcome and objective of the webinarChairs102Overview of the PSUR RepositoryIR153The Post-audit functionalitiesOS104Overview of the APICEE205Expected impact of the API on your IT infrastructureOS and CEE106Expected impact of the API on your business processesIR107Feedback from the surveyIR and OS108Q&AAll309Proposed strategy to support NCAs in dealing with the impact of using the APIWrap-upChairs10

2. Overview of the PSUR Repository(2/11)Legal context Article 25a of Reg. (EC) 726/2004 further clarifies:The Agency shall, in collaboration with the national competent authorities and the Commission,and after consultation with the Pharmacovigilance Risk Assessment Committee, draw up thefunctional specifications for the repository. PRAC adopted the auditable requirements, which were then endorsed by EMA MB Dec 2013 The Management Board of the Agency shall, on the basis of an independent audit reportthat takes into account the recommendations of the Pharmacovigilance Risk AssessmentCommittee, confirm and announce when the repository has achieved full functionality andmeets the functional specifications drawn up pursuant to the second paragraph. Independent audit PRAC recommendation April 2015 EMA MB announcement June 20154

2. Overview of the PSUR Repository(3/11)What is the repository? Mandated by legislation Central storage place for all PSURs and associated reports, incl.outcome documents Submission point of PSURs for MAHs Access by NCAs, the Commission, the PRAC, the CMDh and theCHMP Query and download functionalities to authorised users5

2. Overview of the PSUR Repository(4/11)Network involvement during planning, development, testing,deployment and audit There has been a close collaboration with the network throughout the planning,development, testing, and deployment phases. Network was involved in the planning of the Audit activities EU Telematics Governance Structure (IT DEC, IT Directors Plenary, EUTMB) PhV Governance structure through PRAG, PMG2, CMDh, CHMP and PRAC For example: Consultation on API specifications Other initiatives throughout 2015 – 2016 to support NCAs in their change management activities tosupport business process change for mandatory use

2. Overview of the PSUR RepositoryPSUR repository benefits7(5/11)

2. Overview of the PSUR Repository(6/11)How does the PSUR repository work? Web-based user interface for NCAs, Industryand EC Master key: PSUSA procedure number for EUsingle assessment, DLP and active substancefor non-EU single assessment procedure Industry: creation of xml delivery file via UI tobe included in submission to EMA NCAs: search and download documents andupload documents8

2. Overview of the PSUR Repository(7/11)PSUR Repository - Phased Deployment and steps tomandatory useJanuary 2015Pilot Go LivePilotGo live The PSUR ‘golive in pilotphase’ inJanuary 2015 Pilot ongoingwith MAH andNCAsMarch 2015 AuditApril 2015 PRACAudit and PRACRecommendation Positive auditoutcome in March2015 PRACRecommendationadopted in April2015 Final fieldwork toconfirm EMA IPAplanned for 1stweek of June 2015May 2015EMA MBEMA MBannouncementBased onindependent auditoutcome andPRACrecommendationMarch 2015 –March 2016Post-audit releasesPlan has been audited and releasesare being developed and planned: Audit findings – delivered 4 Post-Audit functionalities incl. API(automated connection between NCAsystems and the PSUR Repository) –December 2015 release based on auditedproject plan binding for EMA New and improved functionality deliveredbased on prioritised change requests –multiple releases throughout 2015/2016June 2016Mandatory UseMandatoryUse Followingannouncement byEMA MB in June2015 mandatoryuse within 12months No furthersubmission ofPSURs toindividual NCAs

2. Overview of the PSUR RepositoryActivityActorSubmission ofPSUR/supplementaryinformation (MAH)MAHPilot(8/11)Switch-on Submission to NCA (standard requirements) Submission to EMARetrieval of PSUR/supplementaryinformationNCA Local NCA repository PSUR Repository after receipt of notificationCirculation of AR andcomments by NCAsNCA Manual email PSUR Repository uploadCirculation of AR toMAH by EMAEMAAccess toAR/Comments byNCANCAAccess committeeoutcomes NCANCAMandatoryphasePSUR RepositoryPSUR RepositoryPSUR RepositoryEudralink message Manual email PSUR RepositoryPSUR Repository MMD PSUR Repository

2. Overview of the PSUR Repository(9/11)What was the basis for the current release?10 auditable functionalities – 3 themes1.Submission2.Storage and Retrieval3.Assessment Detailed requirements based on these 10 auditable functionalities were elaboratedby the PSUR repository advisory group (PRAG)11Presentation title (to edit, click Insert Header & Footer)

2. Overview of the PSUR Repository(10/11)4 Plan on post-audit functionalities1. Automated tracking and alerting functionalities to assist the assessment procedure2. Automated two-way exchange (‘API’) of documents held in the PSUR Repositorybetween NCA systems and the PSUR Repository to reduce administrative burden for NCAs3. Work-flow support for assessors and assistance of PSUR Repository administration4. Allowing for the storage and retrieval of PSUR related documents (already deliveredin the auditable release) These additional functionalities, beyond those to be audited, are to be provided in futurepost-audit releases of the PSUR Repository.12

2. Overview of the PSUR Repository(11/11)Plan on future releases [content and timing]:MilestoneTiming“Audit Findings 2” release: EMA business admin screen (allowing for upload of late PSURs) Implementation of remaining IAPs resulting from the audit by PwCMay 2015“Additional Functionalities” release: Additional change requests as prioritised by the Project Advisory Group and PMG2, inparticular CR for additional context in Notifications when uploading ARs or commentsMid Jul 2015(contingency:mid Aug 15)“Post-Audit functionalities” release: The post-audit functionalities, especially the ‘API’ Additional change requests that will be identified during the pilot phase and during theinitial months after the “Switch-On”. These will be prioritised by the Project Advisory Groupand PMG2.Nov 2015(contingency:Dec 15)“Mandatory use” release: Additional change requests that will be identified during the pilot phase and during theinitial months after the “Switch-On”. These will be prioritised by the Project Advisory Groupand PMG2.Mar 2016(contingency:Apr 16)13

3. The Post-audit functionalities#(1/6)TopicRespTimeChairs101Welcome and objective of the webinar2Overview of the PSUR RepositoryIR153The Post-audit functionalitiesOS104Overview of the APICEE205Expected impact of the API on your IT infrastructureOS and CEE106Expected impact of the API on your business processesIR107Feedback from the surveyIR and OS108Q&AAll309Proposed strategy to support NCAs in dealing with the impact of using the APIWrap-upChairs10

3. The Post-audit functionalities(2/6)As has been agreed by a.o. the EUTMB, the PRAC and the EMA MB and documented indocument “EMA/681848/2013” (aka the “Auditable Requirements”), section 4:4. Additional functionalities of the PSUR Repository (post-audit)Taking into account the provisions set out in Article 25a of Regulation (EC) 726/2004, thefunctionalities to be audited are those outlined in section 3.As part of the consultation with Member States, the following additional key functionalities wererequested to be included in the common PSUR Repository:1. Automated tracking and alerting functionalities to assist the assessment procedure2. Automated two-way exchange of documents held in the PSUR Repository between NCAsystems and the PSUR Repository to reduce administrative burden for NCAs3. Work-flow support for assessors and assistance of PSUR Repository administration4. Allowing for the storage and retrieval of PSUR related documentsThese additional functionalities, beyond those to be audited, are to be provided in future post-auditreleases of the PSUR Repository for which further business requirements will be developed withMember States in consultation with the PRAC.15Based on the initial implementation experience, an iterative approach will be followed allowing forimprovement of functionalities if necessary.

3. The Post-audit functionalities(3/6)Agreed deliverables to fulfil the post-audit functionalities: 1. & 3.: Additional notification functionality as part of the “Post-audit” release 2.: A computer-interface (aka API) allowing NCA IT systems to perform automated two-wayexchange of documents held in the PSUR Repository between NCA systems and the PSURRepository 4.: Already provided in the current system16

3. The Post-audit functionalitiesJan 15Feb 15Post go-livesupportContingencyMar 15Apr 15May 15IntermediateReleaseAnnouncego-liveJun 15Jul 15Aug 15(4/6)Sep 15“Pilot”(Note: Period TBC)yarmmSuAudit supportSupport auditAnalyse / assessaudit findingsDevelop Switch On releaseDeploy(in prod)DeployTime permitting:Dev. prioritised CRsJan 16Feb 16Mar 16“Additional CRs”ContingencyReleaseDevelop Audit FindingsreleaseFixFixDeploySet up XCompenvironmentDeployTime permitting:Dev. prioritised CRs (Rel.”Audit-Findings”)DeployDeployDeployDeploy DeployDeployilduBFin altestSupport auditTestTech UAT Re- Fin alplanning testingEMA only test testProvision UATtest casesTech UATPerf Re- Fin altestingEMA onlytest test testNCAginstTePlan for the post-auditProject Phase Closurerelease(s)Update the plan for the post-audit release(s)Auditreportto MBAudit by PWCProgramme management / Project management / Change management&MPAPI spec consultationMC17API specpublishedTechtestingUATNCARe- Fin altest testPerftestMay 16Post-project support.Develop Prioritised CRsDevelop Post-Audit functionalities Prioritised CRsApr 16.Twelve months before mandatory usageFixDeployDec ed full usePrioritised CRsReleaseAudit findingsReleaseNov 15Oct 15TechtestingUATNCARe- Fin altest testPerftest

3. The Post-audit functionalities(5/6)Overview milestones: Nov –Mar: Work with the NCA IT reps to draft the technical API specifications Define with the Advisory Group the specifications for the Additional Notification System End Mar: Draft specifications available for API Implementing post-audit functionality 2 End Mar: Final specifications available for Additional Notification System Implementing post-audit functionality 1 & 3 Apr – May: Consultation within EMRN on the API specifications Including the EU Telematics IT Directors group, the EU Telematics EnterpriseArchitecture Board, 23 Apr – 15 May: Surveys on expected usage of the PSUR Repo API 21 May: Webinar to address both technical and business-process related aspects of the usageof the API Jun: Approved API specifications available Jun - : Other initiatives throughout 2015 – 2016 to support NCAs in their changemanagement activities related to the use of the API. The details of these will be driven by a.o.the feedback from the surveys and the 21 May webinar.