Use case review update 10 September 2018 Agenda item 4.0 Presented by Noemi Manent on DD MONTH YYYY Compliance and Inspection department

Agenda Document considerations (MS) 10 September 2018 Agenda Document considerations (MS) Consolidate considerations and submit RFI to the sponsor (MS) Prepare and submit response to RFI (Sponsor) Use case review update

UC 1019 Document considerations 10 September 2018 UC 1019 Document considerations NOTE: Delete slides from here on before finalising your presentation. Use case review update

Add new consideration The RMS, MSC or additional MSC selects the considerations form. The RMS, MSC or additional MSC selects to add a new consideration. The RMS, MSC or additional MSC populates the considerations fields as per the data specification. The RMS, MSC or additional MSC saves the populated considerations form. The RMS, MSC or additional MSC selects the considerations they would like to share with RMS/other MSC. The RMS, MSC or additional MSC selects to share the consideration with the RMS and all MSC for the clinical trial. Use case review update

UC 1021 consolidate considerations and submit RFI 10 September 2018 UC 1021 consolidate considerations and submit RFI NOTE: Delete slides from here on before finalising your presentation. Use case review update

Consolidate considerations The RMS or MSC selects the consolidate considerations form. The RMS or MSC selects the consideration(s). The RMS or MSC selects to accept the consideration(s) as per business rules. The RMS populates the consolidation section of the form to address the considerations that have been shared as per business rule. The MSC can choose to edit the pre-populated consolidation section for the assess part II process. The RMS or MSC selects to save a draft of the consolidated consideration form. The RMS selects to share the consolidated considerations with all MSC for the validate application/assess part I processes. The RMS or MSC selects to create a request for information as per business rules. The RMS or MSC populates the empty fields in the request for information form as per data specifications. The RMS or MSC selects to submit the request for information form. Use case review update

UC 1022 prepare and submit response to RFI 10 September 2018 UC 1022 prepare and submit response to RFI NOTE: Delete slides from here on before finalising your presentation. Use case review update

Prepare and submit response to RFI The sponsor wants to respond to the RFI submitted by the RMS/MSC and selects the Response to RFI form The sponsor populates the RFI response form as per the response section in the data specification and where required proceeds to edit the application according to business rule R01.02.64 The sponsor selects to save the updates to the response to RFI form The sponsor selects to submit the RFI response form. The sponsor confirms the submission of updates to the application and the RFI response form The sponsor confirms the submission of the response to RFI form The sponsor confirms his agreement with the declaration. Unless this is confirmed the sponsor is unable to proceed with the submission of the response to RFI as per business rule R01.03.19. Use case review update

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Business rules R01.02.12 R01.02.12 Edit application for RFI ID Name Description MOSCOW R01.02.12 R01.02.12 Edit application for RFI The applicant shall only be able to submit an updated clinical trial application during the evaluation of the trial in the time allowed by the RFI issued by the MSC requesting additional information. Must R01.02.64 R01.02.64 RFI application edits The entire application will be available to edit when an RFI has been received during the validation process. When an RFI is received for a part I or apart II application only information within those parts of the application can be edited. R01.03.19 R01.03.19 Agreement Declaration The applicant must accept the agreement declaration to be able to submit a clinical trial application or a response to an RFI through the EU portal to the Database. R02.02.60 R02.02.60 Sponsor response documents When responding to an RFI, only a subsequent version of the document can be uploaded without the ability to delete previous version(s) submitted. R02.03.28 R02.03.28 Submit additional information timer (B) lapse If the timer (B) lapses, the status of the Part I application shall be 'Lapsed' in all MSC. Use case review update

Business rules ID Name Description MOSCOW R02.03.29 R02.03.29 Provide additional information reminder for part I The Sponsor shall be alerted in the EU portal with 2 days remaining to provide additional information during part I assessment. Must R02.04.21 R02.04.21 Provide additional information reminder for part II The Sponsor shall be alerted in the EU portal with 2 days remaining to provide additional information during part II assessment. R02.04.22 R02.04.22 Part II timer (B) lapse If the timer (B) lapses, the status of the Part II application in the applicable MSC shall be 'Lapsed'. R03.04.23 R03.04.23 Document additional considerations reminder for add MSC The Sponsor shall be alerted in the EU portal with 5 days and 1 day remaining (timer C) to provide additional information during assessment of an application for an additional MSC. R03.04.24 R03.04.24 Sponsor to submit additional Part I information timer (C) lapse If the timer (C) lapses, the application for adding additional member states concerned shall become lapsed in the additional MSC. Use case review update

10 September 2018

Thank you for your attention 10 September 2018 Thank you for your attention Further information Please contact me on Noemie.Manent@ema.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact Note: This slide is OPTIONAL. It uses the 'Closing slide' layout. Delete if not needed. Follow us on @EMA_News