Breakout Session 3 Process and Procedures An agency of the European - PowerPoint PPT Presentation

Breakout Session 3 Process and Procedures An agency of the European Union

Moderators Industry Angelika Joos Regulatory Spiros Vamvakas HTA Antje Behring 1 Breakout session 3 Process and procedures 26 November 2013

Issues Reviewing the EMA multi HTA process end to end to optimise: • Co-ordination and communication • Pre meeting preparation • The face to face meeting • The outcome • Prioritisation • Amended development plans during the procedure • Follow up • Quality 2 Breakout session 3 Process and procedures 26 November 2013

Timeline Timeline EMA actions HTA actions Company (CY) Actions Company (CY) contact Pre-notification phase; HTA & EMA 1 to 2 months before submission of Letter of HTAs agree to CY submit LOI + intent (LOI) participate Identifies participating HTAs on to EMA (copy LOI to HTAs) Pre-validation phase EMA coordinators HTAs Start procedure appointed/experts From Day -60: submission of (LOI) = Day -45 Company submission of Draft 1 briefing document + presentation to all Day -45: Pre-Validation Teleconference with HTA/company/EMA SAWP/co-ordinators Day -25 to -15: List of clarifications to cy List of comments to cy Submission of revised draft to EMA EMA administrative Day -5: check Company circulation of Final briefing document (addressing comments/clarifications) to all Day 0: Start of SAWP 1 validated phase SAWP coordinators Internal first reports Day 20: SAWP 2 Initial Discussion List of EMA Discuss F2F agenda Issues to Cy Day 30: setting with EMA project manager Day 45: Day 45 Company Submission of Presentation with response to EMA List of issues to all Day 50-55: Pre -Face to Face (F2F) Teleconference with HTA/ EMA SAWP/co-ordinators / experts SAWP 3 Day 60-62: F2F Meeting with HTA/ EMA SAWP/co-ordinators/ experts/ company By D65 company sends F2F minutes to all meeting participants Review of minutes by HTA and EMA 26 November 2013 Day 70: Send annotated CHMP 3 Adoption / send minutes/written Receive final CHMP final CHMP letter response to cy if agreed letter, HTAs - minutes