Ny forordning klinisk utprøving. LMI 30. mars 2017

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1 Ny forordning klinisk utprøving LMI 30. mars 2017

2 Agenda Forordningen Hva er nytt siden sist Hva gjør EMA? Hva gjør Kommisjonen? Hva gjør Legemiddelverket?

3 Reguleringen EU Reg 536/2014 Vedtatt i Rådet og Parlamentet 16. april 2014 Publisert i OJ 27. mai 2014, L158 Tas i bruk: om minimum 2 år 6 mnd etter at Kommisjonene har publisert at EU-portalen og databasen er funksjonell Implementering Oktober 2018 Kravene til GCP og GMP er videreført

4 Ref: EMA

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6 Sponsor workspace A secure workspace will assist clinical trial sponsors in preparing and compiling data to submit to the database for assessment by Member States. It will allow sponsors to: search and access clinical trials; compile clinical trial application dossiers for new and updated trials; cross-reference to product documents in other clinical trials; supervise their own clinical trials and check progress; receive alerts and notifications for ongoing trials; record clinical trial results; upload documents for clinical trial application form submission; respond to requests for information and view deadlines; manage users and user roles. Ref: EMA

7 Ansvarlig for at Portal bygges Satt opp kravspesifikasjoner for portal og database sammen med medlemslandene Kravspesifikasjon og informasjon på EMA sine hjemmeside

8 Ferdig med UAT 5 8

9 UAT= User Acceptance Testing UAT 5 Optimise testing population based on previous UAT feedback All MS, EC and sponsors organisations still represented Optimise user journeys through system based on critical paths to create highlevel test scenarios Focused freeform group 13 MS testers selected Demo to wider audience UAT dates: 28 February to 08 March 2017 UAT 6 Reduced number of testers as per UAT 5 Grouping of use cases based on business flows Focus on testers testing appropriate pathways On-site tester subgroup (i.e. EMA) (MS/Sponsor/Public) completing collaborative test scenarios Demos to wider audience at intermediate releases (approx. every 4 weeks) UAT dates: 18 May to 06 June 2017 UAT 7 Approach as per UAT 6 Compression of timeline (2 weeks instead of 3) to allow UAT completion prior to audit report release. UAT dates: 17 August to 01 September 2017

10 Timetable for implementation Date Note EUPD Audit Plan: Key dates Sign contract with auditor March 2017 Auditable release 21 July 2017 Audit fieldwork 15 days 21 August 2017 UAT7 starting on 17 August 2017 Audit report 21 September 2017 Draft Report 6 October November 2017 Final Report Addendum to Report Deadline to address audit findings 10 November 2017 Audit Follow up November 2017 Additional on-site visit Presentation to Management Board December 2017 Presentation of 10 report for decision

11 Timetable for implementation Date Note EUPD Audit Plan: Key dates European Commission notice published in Official Journal of the EU Production Version completed, including implementation of remaining should requirements March 2018 July 2018 Production version go live September 2018 Regulation (EU) No 536/2014 becomes applicable October 2018 Further upgrade and enhancement of the system completed Directive on Clinical Trials 2001/20/EC no longer applicable Q October 2021

12 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) Create back-ups 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) Approves Regular users Regular users Regular users Role allocated to perform activities in the system to self-registered users

13 Permissions and roles Permissions example Roles example Users A flexible system that can be adapted in the near future Mix and match Administrators Coordinator Assign roles to people Business Roles Viewer Preparer Submitters Roles will be created by grouping respective permissions View Create Delete Share Assign/release task Each user can be assigned one or more roles to allow him/her to execute relevant actions in the system Submit Update Withdrawal Assign roles/trials

14 Roles Matrix- Key principles The roles matrix describe the roles identified and the permissions mapped to those roles that allow performing activities in the system Roles will be pre-configured in the system by grouping their respective permissions Functionality available to a given user can be customised through the combination of one or more roles A total of 46 roles have been defined: 23 MS roles (20 business roles and 3 related admin roles) 4 EU Commission (3 business roles and 1 related admin roles) 14 sponsor roles (12 business roles and 2 related admin roles) 3 MAH roles (2 business roles and 1 related admin roles) 2 additional roles: o o EMA Administrator Default role (this role contain birth permissions required before a role is given) 14

15 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 & non-commercial sponsors Lead trainers use knowledge and online material to train colleagues Online material (refer to the Online training section) The EMA provides on- going support through Webinars, Query management, etc. Targeted at: Targeted at: Targeted at: Targeted at: All stakeholders Member States Member States All stakeholders 2017: 3 trainings planned Large commercial sponsors Primary focus of training 2018: 3 trainings planned Large commercial sponsors SME s Non-commercial sponsors SME s Non-commercial sponsors

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17 Kommisjonen Vedtatt forordningen Ansvarlig for retningslinjer - arbeidsgrupper Etter implementering: Union Control

18 Offentlig høringer - avslutta Disse publiseres Q2 2017: Risk proportionate approaches in clinical trials Summary of Clinical Trial Results for laypersons Definition of investigational medicinal products and use of auxiliary medicinal products Ethical considerations for clinical trials on medicinal products conducted with minor Flere retningslinjer under arbeid: Question & Answer Guideline on transitory period for the application of Regulation (EU) No 536/2014

19 Andre relevante dokumenter Alle lovfestede documenter (forpliktelser) skal gjøres ferdig og publiseres i Q Delegated act on GCP - høringer ferdig - ferdigstilles Delegated act on GMP høringer ferdig - ferdigstilles Detailed guideline on good clinical practice specific for advanced therapy medicinal products (advanced draft) Guidance to cover the aspect of shipping (distribution)of IMPs and the second step of the two-step release procedure to address interfaces between the manufacturer and the sponsor of the clinical trial (to be developed)

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21 REK - Legemiddelverket Forskriftsarbeidet i Norge er ferdig fra SLV sin side SLV deltar VHP planlegger å øke innsatsen Organisering av REK Dialog med REKene Jevnlige møter Hvem gjør hva SLV validerer og koordinerer? Hvordan fordele arbeidet skriving av utredningsrapport(er) når vi er RMS? Hvordan kommunisere med hverandre? Ressurser: SLV mer ressurser til koordinering og utredning Deltar i EU-fora Avgift nasjonalt anliggende, men kun en avgift pr land Ligger foreløpig hos HOD Forsikring nasjonalt anliggende- har begynt å se på.

22 2018 Informasjonsmøter Informasjon på nettet Foredrag/informasjon på forespørsel

23 Oppsummering Mars 2018 publisering at portalen er godkjent Oktober 2018 trer i kraft Opplæring EMA i 2017 og 2018: Portal og database SLV/REK: Informasjon og mer opplæring REK og SLV jobber med avklaringer om samarbeid og tekniske løsninger

24 Følg legemiddelverket legemiddelverket.no