BEGIN:VCALENDAR VERSION:2.0 PRODID:-//VigiEye//EU Regulatory Calendar//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:VigiEye — EU regulatory calendar X-WR-CALDESC:EU pharma regulatory and pharmacovigilance dates (vigi-eye.com/calendar) BEGIN:VEVENT UID:2026-10-31-ema-consultation-closes-concept-paper-revision-of-biosimilar-guidelin@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261031 DTEND;VALUE=DATE:20261101 SUMMARY:[EMA] Consultation closes: Concept paper: revision of biosimilar g uideline (CHMP/437/04 Rev.1) DESCRIPTION:Biosimilar developers and MAHs can comment on planned changes to EU data requirements for similar biological medicines.\nSource: https: //www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revis ion-guideline-similar-biological-medicinal-products-chmp-437-04-rev1_en.p df\nhttps://vigi-eye.com/calendar/2026-10-31-ema-consultation-closes-conc ept-paper-revision-of-biosimilar-guidelin URL:https://vigi-eye.com/calendar/2026-10-31-ema-consultation-closes-conce pt-paper-revision-of-biosimilar-guidelin TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-10-31-ema-consultation-closes-semaglutide-flextouch-pen-product-specific-be@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261031 DTEND;VALUE=DATE:20261101 SUMMARY:[EMA] Consultation closes: Semaglutide FlexTouch pen product-speci fic BE guidance DESCRIPTION:Generic developers of semaglutide pens can comment on the bioe quivalence approach.\nSource: https://www.ema.europa.eu/en/documents/scie ntific-guideline/semaglutide-flextouch-solution-injection-pre-filled-pen- product-specific-bioequivalence-guidance-various-strengths_en.pdf\nhttps: //vigi-eye.com/calendar/2026-10-31-ema-consultation-closes-semaglutide-fl extouch-pen-product-specific-be URL:https://vigi-eye.com/calendar/2026-10-31-ema-consultation-closes-semag lutide-flextouch-pen-product-specific-be TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-10-31-ema-consultation-closes-weight-management-guideline-paediatric-addend@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261031 DTEND;VALUE=DATE:20261101 SUMMARY:[EMA] Consultation closes: Weight management guideline: paediatric addendum DESCRIPTION:Comments on clinical development requirements for weight-contr ol medicines in children.\nSource: https://www.ema.europa.eu/en/documents /scientific-guideline/guideline-clinical-evaluation-medicinal-products-we ight-management-addendum-weight-control-children_en.pdf\nhttps://vigi-eye .com/calendar/2026-10-31-ema-consultation-closes-weight-management-guidel ine-paediatric-addend URL:https://vigi-eye.com/calendar/2026-10-31-ema-consultation-closes-weigh t-management-guideline-paediatric-addend TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-10-31-ema-consultation-closes-concept-paper-rnai-antisense-veterinary-thera@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261031 DTEND;VALUE=DATE:20261101 SUMMARY:[EMA] Consultation closes: Concept paper: RNAi / antisense veterin ary therapies (CVMP) DESCRIPTION:Veterinary developers can comment on quality and safety expect ations for oligonucleotide products.\nSource: https://www.ema.europa.eu/e n/documents/scientific-guideline/concept-paper-quality-safety-aspects-rna -interference-rna-antisense-oligonucleotide-therapies-veterinary-medicina l-products_en.pdf\nhttps://vigi-eye.com/calendar/2026-10-31-ema-consultat ion-closes-concept-paper-rnai-antisense-veterinary-thera URL:https://vigi-eye.com/calendar/2026-10-31-ema-consultation-closes-conce pt-paper-rnai-antisense-veterinary-thera TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-10-31-ema-consultation-closes-concept-paper-veterinary-fixed-combination-pr@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261031 DTEND;VALUE=DATE:20261101 SUMMARY:[EMA] Consultation closes: Concept paper: veterinary fixed-combina tion products guideline revision DESCRIPTION:Veterinary MAHs can comment on the planned revision.\nSource: https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper -revision-guideline-pharmaceutical-fixed-combination-products-ema-cvmp-83 804-2005-rev1_en.pdf\nhttps://vigi-eye.com/calendar/2026-10-31-ema-consul tation-closes-concept-paper-veterinary-fixed-combination-pr URL:https://vigi-eye.com/calendar/2026-10-31-ema-consultation-closes-conce pt-paper-veterinary-fixed-combination-pr TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-03-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261103 DTEND;VALUE=DATE:20261106 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/other/committee-orphan-medicinal -products-comp-meetings-2023-2024-2025-and-2026_en.pdf\nhttps://vigi-eye. com/calendar/2026-11-03-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2026-11-03-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-04-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261104 DTEND;VALUE=DATE:20261107 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/events /committee-advanced-therapies-cat-4-6-november-2026\nhttps://vigi-eye.com /calendar/2026-11-04-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2026-11-04-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-08-ispor-ispor-europe-2026-vienna@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261108 DTEND;VALUE=DATE:20261112 SUMMARY:[ISPOR] ISPOR Europe 2026 (Vienna) DESCRIPTION:Europe's main HEOR and market-access conference: HTA\, the EU Joint Clinical Assessment\, pricing and real-world evidence. Austria Cent er Vienna.\nSource: \nhttps://vigi-eye.com/calendar/2026-11-08-ispor-ispo r-europe-2026-vienna URL:https://vigi-eye.com/calendar/2026-11-08-ispor-ispor-europe-2026-vienn a TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-09-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261109 DTEND;VALUE=DATE:20261113 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/en/documents/other/chmp-meeting-dates-2023-2024 -2025-and-2026_en.pdf\nhttps://vigi-eye.com/calendar/2026-11-09-chmp-chmp -plenary-meeting URL:https://vigi-eye.com/calendar/2026-11-09-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-10-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261110 DTEND;VALUE=DATE:20261114 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/documents /other/pdco-meetings-2023-2024-2025-2026_en.pdf\nhttps://vigi-eye.com/cal endar/2026-11-10-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2026-11-10-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-23-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261123 DTEND;VALUE=DATE:20261127 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/events/pharmacovigilance-risk-assessment -committee-prac-23-26-november-2026\nhttps://vigi-eye.com/calendar/2026-1 1-23-prac-prac-plenary-meeting URL:https://vigi-eye.com/calendar/2026-11-23-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-28-european-commission-eudamed-device-registration-deadline@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261128 DTEND;VALUE=DATE:20261129 SUMMARY:[European Commission] EUDAMED: device registration deadline DESCRIPTION:End of the 12-month transition for registering legacy devices and MDR/IVDR devices already on the market before 28 May 2026 in the EUDA MED UDI/Device module. Manufacturers should complete outstanding device r egistrations now.\nSource: https://health.ec.europa.eu/document/download/ 9aea934d-85b0-4118-92e0-ec6b7c8fdc95_en?filename=md_eudamed_tp-cert-devic es_en.pdf\nhttps://vigi-eye.com/calendar/2026-11-28-european-commission-e udamed-device-registration-deadline URL:https://vigi-eye.com/calendar/2026-11-28-european-commission-eudamed-d evice-registration-deadline TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-01-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20261204 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/other/committee-orphan-medicinal -products-comp-meetings-2023-2024-2025-and-2026_en.pdf\nhttps://vigi-eye. com/calendar/2026-12-01-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2026-12-01-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-02-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261202 DTEND;VALUE=DATE:20261205 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/events /committee-advanced-therapies-cat-2-4-december-2026\nhttps://vigi-eye.com /calendar/2026-12-02-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2026-12-02-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-07-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261207 DTEND;VALUE=DATE:20261211 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/en/documents/other/chmp-meeting-dates-2023-2024 -2025-and-2026_en.pdf\nhttps://vigi-eye.com/calendar/2026-12-07-chmp-chmp -plenary-meeting URL:https://vigi-eye.com/calendar/2026-12-07-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-08-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261208 DTEND;VALUE=DATE:20261212 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/documents /other/pdco-meetings-2023-2024-2025-2026_en.pdf\nhttps://vigi-eye.com/cal endar/2026-12-08-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2026-12-08-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-14-ema-consultation-closes-draft-data-quality-framework-for-adr-reports@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261214 DTEND;VALUE=DATE:20261215 SUMMARY:[EMA] Consultation closes: Draft Data Quality Framework for ADR re ports DESCRIPTION:Directly relevant to PV teams: sets data-quality expectations for collecting\, managing and submitting ICSRs. MAHs and QPPVs should rev iew and comment.\nSource: https://www.ema.europa.eu/en/documents/regulato ry-procedural-guideline/draft-data-quality-framework-dqf-eu-medicines-reg ulation-application-collection-management-submission-adverse-drug-reactio n-reports_en.pdf\nhttps://vigi-eye.com/calendar/2026-12-14-ema-consultati on-closes-draft-data-quality-framework-for-adr-reports URL:https://vigi-eye.com/calendar/2026-12-14-ema-consultation-closes-draft -data-quality-framework-for-adr-reports TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-18-ema-consultation-closes-draft-vgvp-module-signal-management-rev-1@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261218 DTEND;VALUE=DATE:20261219 SUMMARY:[EMA] Consultation closes: Draft VGVP module: Signal management Re v.1 DESCRIPTION:Veterinary MAHs and PV teams can comment on revised veterinary signal management rules.\nSource: https://www.ema.europa.eu/en/documents /regulatory-procedural-guideline/draft-guideline-veterinary-good-pharmaco vigilance-practices-vgvp-module-signal-management-revision-1_en.pdf\nhttp s://vigi-eye.com/calendar/2026-12-18-ema-consultation-closes-draft-vgvp-m odule-signal-management-rev-1 URL:https://vigi-eye.com/calendar/2026-12-18-ema-consultation-closes-draft -vgvp-module-signal-management-rev-1 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-31-ema-consultation-closes-draft-guideline-on-user-safety-of-veterinary@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261231 DTEND;VALUE=DATE:20270101 SUMMARY:[EMA] Consultation closes: Draft guideline on user safety of veter inary products Rev.2 DESCRIPTION:Veterinary applicants can comment on user-safety assessment re quirements.\nSource: https://www.ema.europa.eu/en/documents/scientific-gu ideline/draft-guideline-user-safety-pharmaceutical-veterinary-medicinal-p roducts-revision-2_en.pdf\nhttps://vigi-eye.com/calendar/2026-12-31-ema-c onsultation-closes-draft-guideline-on-user-safety-of-veterinary URL:https://vigi-eye.com/calendar/2026-12-31-ema-consultation-closes-draft -guideline-on-user-safety-of-veterinary TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-31-ema-consultation-closes-concept-paper-spc-guideline-for-veterinary-an@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261231 DTEND;VALUE=DATE:20270101 SUMMARY:[EMA] Consultation closes: Concept paper: SPC guideline for veteri nary antimicrobials DESCRIPTION:Veterinary MAHs can comment on planned SPC wording rules for a ntimicrobials.\nSource: https://www.ema.europa.eu/en/documents/scientific -guideline/concept-paper-revision-cvmp-guideline-summary-product-characte ristics-spc-veterinary-medicinal-products-containing-antimicrobial-substa nces-ema-cvmp-383441-2005-rev1-corr1_en.pdf\nhttps://vigi-eye.com/calenda r/2026-12-31-ema-consultation-closes-concept-paper-spc-guideline-for-vete rinary-an URL:https://vigi-eye.com/calendar/2026-12-31-ema-consultation-closes-conce pt-paper-spc-guideline-for-veterinary-an TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-12-31-ema-consultation-closes-draft-guideline-on-gastrointestinal-tract-int@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20261231 DTEND;VALUE=DATE:20270101 SUMMARY:[EMA] Consultation closes: Draft guideline on gastrointestinal-tra ct interactions DESCRIPTION:Developers of oral medicines can comment on how GI interaction s (e.g. food\, acid reducers) should be investigated.\nSource: https://ww w.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-investi gation-interactions-gastrointestinal-tract_en.pdf\nhttps://vigi-eye.com/c alendar/2026-12-31-ema-consultation-closes-draft-guideline-on-gastrointes tinal-tract-int URL:https://vigi-eye.com/calendar/2026-12-31-ema-consultation-closes-draft -guideline-on-gastrointestinal-tract-int TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-11-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270111 DTEND;VALUE=DATE:20270115 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-01-11-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-01-11-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-15-ema-consultation-closes-draft-reflection-paper-on-herbal-drug-interac@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270115 DTEND;VALUE=DATE:20270116 SUMMARY:[EMA] Consultation closes: Draft reflection paper on herbal drug i nteractions DESCRIPTION:Herbal MAHs can comment on how interactions of herbal medicina l products should be investigated.\nSource: https://www.ema.europa.eu/en/ documents/scientific-guideline/draft-reflection-paper-investigation-drug- interactions-herbal-medicinal-products_en.pdf\nhttps://vigi-eye.com/calen dar/2027-01-15-ema-consultation-closes-draft-reflection-paper-on-herbal-d rug-interac URL:https://vigi-eye.com/calendar/2027-01-15-ema-consultation-closes-draft -reflection-paper-on-herbal-drug-interac TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-15-ich-ich-e6-r3-annex-2-comes-into-effect@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270115 DTEND;VALUE=DATE:20270116 SUMMARY:[ICH] ICH E6(R3) Annex 2 comes into effect DESCRIPTION:The GCP Annex 2 (decentralised\, pragmatic and real-world-data elements of clinical trials) applies in the EU. Sponsors and CROs should update SOPs and trial oversight plans.\nSource: https://www.ema.europa.e u/en/documents/scientific-guideline/ich-e6r3-guideline-good-clinical-prac tice-annex-2-step-5_en.pdf\nhttps://vigi-eye.com/calendar/2027-01-15-ich- ich-e6-r3-annex-2-comes-into-effect URL:https://vigi-eye.com/calendar/2027-01-15-ich-ich-e6-r3-annex-2-comes-i nto-effect TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-19-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270119 DTEND;VALUE=DATE:20270122 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-01-19-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-01-19-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-20-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270120 DTEND;VALUE=DATE:20270123 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-01-20-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-01-20-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-25-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270125 DTEND;VALUE=DATE:20270129 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-01-25-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-01-25-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-26-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270126 DTEND;VALUE=DATE:20270130 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-01-26-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-01-26-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-reflection-paper-confirmatory-platform-trials@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Reflection paper: confirmatory platform trials DESCRIPTION:Sponsors running platform trials can comment on methodological expectations for confirmatory evidence.\nSource: https://www.ema.europa. eu/en/documents/scientific-guideline/reflection-paper-methodological-aspe cts-confirmatory-platform-trials_en.pdf\nhttps://vigi-eye.com/calendar/20 27-01-31-ema-consultation-closes-reflection-paper-confirmatory-platform-t rials URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-refle ction-paper-confirmatory-platform-trials TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-draft-guideline-migraine-and-cluster-headache@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Draft guideline: migraine and cluster h eadache Rev.2 DESCRIPTION:Developers in headache disorders can comment on revised clinic al trial requirements.\nSource: https://www.ema.europa.eu/en/documents/sc ientific-guideline/draft-guideline-clinical-investigation-medicinal-produ cts-treatment-migraine-cluster-headache-revision-2_en.pdf\nhttps://vigi-e ye.com/calendar/2027-01-31-ema-consultation-closes-draft-guideline-migrai ne-and-cluster-headache URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-draft -guideline-migraine-and-cluster-headache TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-draft-guideline-sickle-cell-disease-medicines@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Draft guideline: sickle cell disease me dicines DESCRIPTION:Developers can comment on clinical requirements for sickle cel l disease products.\nSource: https://www.ema.europa.eu/en/documents/scien tific-guideline/draft-guideline-clinical-requirements-medicines-intended- treatment-sickle-cell-disease_en.pdf\nhttps://vigi-eye.com/calendar/2027- 01-31-ema-consultation-closes-draft-guideline-sickle-cell-disease-medicin es URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-draft -guideline-sickle-cell-disease-medicines TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-draft-guideline-thalassaemia-medicines@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Draft guideline: thalassaemia medicines DESCRIPTION:Developers can comment on clinical requirements for thalassaem ia products.\nSource: https://www.ema.europa.eu/en/documents/scientific-g uideline/draft-guideline-clinical-requirements-medicines-intended-treatme nt-thalassaemia_en.pdf\nhttps://vigi-eye.com/calendar/2027-01-31-ema-cons ultation-closes-draft-guideline-thalassaemia-medicines URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-draft -guideline-thalassaemia-medicines TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-concept-paper-hypertension-guideline-revision@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Concept paper: hypertension guideline r evision DESCRIPTION:Comments on planned revision of the hypertension clinical inve stigation guideline.\nSource: https://www.ema.europa.eu/en/documents/scie ntific-guideline/concept-paper-need-revision-guideline-clinical-investiga tion-medicinal-products-treatment-hypertension-ema-chmp-29947-2013-rev4_e n.pdf\nhttps://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-c oncept-paper-hypertension-guideline-revision URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-conce pt-paper-hypertension-guideline-revision TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-concept-paper-kidney-transplant-recipient-tri@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Concept paper: kidney transplant recipi ent trials DESCRIPTION:Comments on a planned guideline for trials in kidney transplan t recipients.\nSource: https://www.ema.europa.eu/en/documents/scientific- guideline/concept-paper-clinical-trials-recipients-kidney-transplantation _en.pdf\nhttps://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes -concept-paper-kidney-transplant-recipient-tri URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-conce pt-paper-kidney-transplant-recipient-tri TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-concept-paper-inherited-retinal-dystrophies-g@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Concept paper: inherited retinal dystro phies guideline DESCRIPTION:Comments on the need for a guideline on inherited retinal dyst rophy treatments.\nSource: https://www.ema.europa.eu/en/documents/scienti fic-guideline/concept-paper-need-guideline-clinical-investigation-medicin al-products-treatment-inherited-retinal-dystrophies_en.pdf\nhttps://vigi- eye.com/calendar/2027-01-31-ema-consultation-closes-concept-paper-inherit ed-retinal-dystrophies-g URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-conce pt-paper-inherited-retinal-dystrophies-g TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-raltegravir-product-specific-be-guidance@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Raltegravir product-specific BE guidanc e DESCRIPTION:Generic developers can comment on the bioequivalence approach for raltegravir.\nSource: https://www.ema.europa.eu/en/documents/scientif ic-guideline/raltegravir-product-specific-bioequivalence-guidance-400-mg- 600-mg-film-coated-tablet-25-100-mg-chewable-tablet-100-mg-granules-oral- suspension_en.pdf\nhttps://vigi-eye.com/calendar/2027-01-31-ema-consultat ion-closes-raltegravir-product-specific-be-guidance URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-ralte gravir-product-specific-be-guidance TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-niraparib-product-specific-be-guidance@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Niraparib product-specific BE guidance DESCRIPTION:Generic developers can comment on the bioequivalence approach for niraparib.\nSource: https://www.ema.europa.eu/en/documents/scientific -guideline/niraparib-hard-capsules-100-mg-film-coated-tablets-100-mg-prod uct-specific-bioequivalence-guidance_en.pdf\nhttps://vigi-eye.com/calenda r/2027-01-31-ema-consultation-closes-niraparib-product-specific-be-guidan ce URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-nirap arib-product-specific-be-guidance TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-31-ema-consultation-closes-oral-semaglutide-product-specific-be-guidance@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270131 DTEND;VALUE=DATE:20270201 SUMMARY:[EMA] Consultation closes: Oral semaglutide product-specific BE gu idance DESCRIPTION:Generic developers can comment on the bioequivalence approach for semaglutide tablets.\nSource: https://www.ema.europa.eu/en/documents/ scientific-guideline/semaglutide-tablet-15-4-9-25-50-mg-product-specific- bioequivalence-guidance_en.pdf\nhttps://vigi-eye.com/calendar/2027-01-31- ema-consultation-closes-oral-semaglutide-product-specific-be-guidance URL:https://vigi-eye.com/calendar/2027-01-31-ema-consultation-closes-oral- semaglutide-product-specific-be-guidance TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-02-08-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270208 DTEND;VALUE=DATE:20270212 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-02-08-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-02-08-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-02-16-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270216 DTEND;VALUE=DATE:20270219 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-02-16-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-02-16-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-02-17-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270217 DTEND;VALUE=DATE:20270220 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-02-17-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-02-17-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-02-22-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270222 DTEND;VALUE=DATE:20270226 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-02-22-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-02-22-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-02-23-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270223 DTEND;VALUE=DATE:20270227 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-02-23-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-02-23-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-02-28-ema-consultation-closes-draft-guideline-therapeutic-equivalence-of-na@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270228 DTEND;VALUE=DATE:20270301 SUMMARY:[EMA] Consultation closes: Draft guideline: therapeutic equivalenc e of nasal products DESCRIPTION:Generic/hybrid developers of nasal products can comment on equ ivalence requirements.\nSource: https://www.ema.europa.eu/en/documents/sc ientific-guideline/draft-guideline-requirements-demonstrating-therapeutic -equivalence-nasal-products_en.pdf\nhttps://vigi-eye.com/calendar/2027-02 -28-ema-consultation-closes-draft-guideline-therapeutic-equivalence-of-na URL:https://vigi-eye.com/calendar/2027-02-28-ema-consultation-closes-draft -guideline-therapeutic-equivalence-of-na TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-03-15-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270315 DTEND;VALUE=DATE:20270319 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-03-15-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-03-15-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-03-22-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270322 DTEND;VALUE=DATE:20270325 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-03-22-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-03-22-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-03-22-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270322 DTEND;VALUE=DATE:20270325 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-03-22-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-03-22-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-03-30-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270330 DTEND;VALUE=DATE:20270403 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-03-30-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-03-30-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-03-30-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270330 DTEND;VALUE=DATE:20270403 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-03-30-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-03-30-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-03-31-ema-consultation-closes-draft-reflection-paper-systemic-sclerosis@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270331 DTEND;VALUE=DATE:20270401 SUMMARY:[EMA] Consultation closes: Draft reflection paper: systemic sclero sis DESCRIPTION:Developers can comment on clinical investigation expectations in systemic sclerosis.\nSource: https://www.ema.europa.eu/en/documents/sc ientific-guideline/draft-reflection-paper-clinical-investigation-medicina l-products-treatment-systemic-sclerosis_en.pdf\nhttps://vigi-eye.com/cale ndar/2027-03-31-ema-consultation-closes-draft-reflection-paper-systemic-s clerosis URL:https://vigi-eye.com/calendar/2027-03-31-ema-consultation-closes-draft -reflection-paper-systemic-sclerosis TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-04-12-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270412 DTEND;VALUE=DATE:20270416 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-04-12-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-04-12-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-04-20-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270420 DTEND;VALUE=DATE:20270423 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-04-20-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-04-20-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-04-21-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270421 DTEND;VALUE=DATE:20270424 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-04-21-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-04-21-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-04-28-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270428 DTEND;VALUE=DATE:20270501 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-04-28-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-04-28-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-04-28-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270428 DTEND;VALUE=DATE:20270501 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-04-28-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-04-28-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-10-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270510 DTEND;VALUE=DATE:20270514 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-05-10-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-05-10-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-18-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270518 DTEND;VALUE=DATE:20270521 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-05-18-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-05-18-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-19-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270519 DTEND;VALUE=DATE:20270522 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-05-19-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-05-19-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-23-ispor-ispor-2027-denver@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270523 DTEND;VALUE=DATE:20270527 SUMMARY:[ISPOR] ISPOR 2027 (Denver) DESCRIPTION:ISPOR's annual international HEOR conference: value assessment \, US pricing policy\, real-world evidence. Colorado Convention Center\, Denver.\nSource: \nhttps://vigi-eye.com/calendar/2027-05-23-ispor-ispor-2 027-denver URL:https://vigi-eye.com/calendar/2027-05-23-ispor-ispor-2027-denver TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-24-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270524 DTEND;VALUE=DATE:20270528 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-05-24-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-05-24-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-25-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270525 DTEND;VALUE=DATE:20270529 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-05-25-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-05-25-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-26-european-commission-ivdr-class-b-sterile-class-a-nb-application-deadl@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270526 DTEND;VALUE=DATE:20270527 SUMMARY:[European Commission] IVDR: class B / sterile class A NB applicati on deadline DESCRIPTION:Legacy class B and sterile class A IVDs only benefit from the extended transition (to 31 Dec 2029) if a formal application to a notifie d body is lodged by this date.\nSource: https://eur-lex.europa.eu/legal-c ontent/EN/TXT/PDF/?uri=OJ:L_202401860\nhttps://vigi-eye.com/calendar/2027 -05-26-european-commission-ivdr-class-b-sterile-class-a-nb-application-de adl URL:https://vigi-eye.com/calendar/2027-05-26-european-commission-ivdr-clas s-b-sterile-class-a-nb-application-deadl TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-05-28-european-commission-eudamed-certificate-registration-deadline@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270528 DTEND;VALUE=DATE:20270529 SUMMARY:[European Commission] EUDAMED: certificate registration deadline DESCRIPTION:End of the 18-month transition for registering MDR/IVDR certif icates issued before 28 May 2026 in the EUDAMED Notified Bodies & Certifi cates module. Manufacturers should confirm with their notified body that all certificates are uploaded.\nSource: https://health.ec.europa.eu/docum ent/download/9aea934d-85b0-4118-92e0-ec6b7c8fdc95_en?filename=md_eudamed_ tp-cert-devices_en.pdf\nhttps://vigi-eye.com/calendar/2027-05-28-european -commission-eudamed-certificate-registration-deadline URL:https://vigi-eye.com/calendar/2027-05-28-european-commission-eudamed-c ertificate-registration-deadline TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-06-07-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270607 DTEND;VALUE=DATE:20270611 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-06-07-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-06-07-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-06-15-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270615 DTEND;VALUE=DATE:20270618 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-06-15-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-06-15-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-06-16-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270616 DTEND;VALUE=DATE:20270619 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-06-16-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-06-16-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-06-21-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270621 DTEND;VALUE=DATE:20270625 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-06-21-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-06-21-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-06-22-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270622 DTEND;VALUE=DATE:20270626 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-06-22-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-06-22-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-07-05-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270705 DTEND;VALUE=DATE:20270709 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-07-05-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-07-05-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-07-13-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270713 DTEND;VALUE=DATE:20270716 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-07-13-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-07-13-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-07-14-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270714 DTEND;VALUE=DATE:20270717 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-07-14-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-07-14-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-07-19-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270719 DTEND;VALUE=DATE:20270723 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-07-19-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-07-19-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-07-27-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270727 DTEND;VALUE=DATE:20270731 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-07-27-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-07-27-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-08-11-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270811 DTEND;VALUE=DATE:20270814 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-08-11-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-08-11-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-08-30-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270830 DTEND;VALUE=DATE:20270903 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-08-30-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-08-30-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-09-07-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270907 DTEND;VALUE=DATE:20270910 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-09-07-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-09-07-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-09-07-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270907 DTEND;VALUE=DATE:20270911 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-09-07-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-09-07-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-09-08-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270908 DTEND;VALUE=DATE:20270911 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-09-08-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-09-08-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-09-13-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270913 DTEND;VALUE=DATE:20270917 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-09-13-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-09-13-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-09-26-european-commission-ivdr-class-b-sterile-class-a-nb-written-agreement@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270926 DTEND;VALUE=DATE:20270927 SUMMARY:[European Commission] IVDR: class B / sterile class A NB written a greement DESCRIPTION:To keep the transition to 31 Dec 2029\, manufacturers of legac y class B and sterile class A IVDs must have a signed written agreement w ith a notified body by this date.\nSource: https://eur-lex.europa.eu/lega l-content/EN/TXT/PDF/?uri=OJ:L_202401860\nhttps://vigi-eye.com/calendar/2 027-09-26-european-commission-ivdr-class-b-sterile-class-a-nb-written-agr eement URL:https://vigi-eye.com/calendar/2027-09-26-european-commission-ivdr-clas s-b-sterile-class-a-nb-written-agreement TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-09-27-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20270927 DTEND;VALUE=DATE:20271001 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-09-27-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-09-27-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-10-05-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271005 DTEND;VALUE=DATE:20271008 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-10-05-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-10-05-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-10-06-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271006 DTEND;VALUE=DATE:20271009 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-10-06-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-10-06-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-10-11-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271011 DTEND;VALUE=DATE:20271015 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-10-11-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-10-11-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-10-12-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271012 DTEND;VALUE=DATE:20271016 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-10-12-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-10-12-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-10-25-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271025 DTEND;VALUE=DATE:20271029 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-10-25-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-10-25-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-11-03-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271103 DTEND;VALUE=DATE:20271106 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-11-03-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-11-03-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-11-03-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271103 DTEND;VALUE=DATE:20271106 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-11-03-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-11-03-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-11-08-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271108 DTEND;VALUE=DATE:20271112 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-11-08-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-11-08-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-11-14-ispor-ispor-europe-2027-milan@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271114 DTEND;VALUE=DATE:20271118 SUMMARY:[ISPOR] ISPOR Europe 2027 (Milan) DESCRIPTION:ISPOR's European HEOR and market-access conference. Allianz Mi Co\, Milan.\nSource: \nhttps://vigi-eye.com/calendar/2027-11-14-ispor-isp or-europe-2027-milan URL:https://vigi-eye.com/calendar/2027-11-14-ispor-ispor-europe-2027-milan TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-11-16-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271116 DTEND;VALUE=DATE:20271120 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-11-16-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-11-16-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-11-29-prac-prac-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271129 DTEND;VALUE=DATE:20271203 SUMMARY:[PRAC] PRAC plenary meeting DESCRIPTION:PRAC plenary: safety signals\, PSUSA outcomes\, RMPs and refer rals are discussed. MAHs should check the agenda for their substances and prepare for signal recommendations that may require label updates.\nSour ce: https://www.ema.europa.eu/en/documents/other/prac-meetings-2027-2028_ en.pdf\nhttps://vigi-eye.com/calendar/2027-11-29-prac-prac-plenary-meetin g URL:https://vigi-eye.com/calendar/2027-11-29-prac-prac-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-12-02-european-commission-ai-act-annex-iii-high-risk-rules-apply@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271202 DTEND;VALUE=DATE:20271203 SUMMARY:[European Commission] AI Act: Annex III high-risk rules apply DESCRIPTION:Following the Digital Omnibus on AI\, obligations for stand-al one high-risk AI systems listed in Annex III apply from this date. Health organisations deploying such systems should complete risk-management and documentation work.\nSource: https://ai-act-service-desk.ec.europa.eu/en /ai-act/timeline/timeline-implementation-eu-ai-act\nhttps://vigi-eye.com/ calendar/2027-12-02-european-commission-ai-act-annex-iii-high-risk-rules- apply URL:https://vigi-eye.com/calendar/2027-12-02-european-commission-ai-act-an nex-iii-high-risk-rules-apply TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-12-07-comp-comp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271207 DTEND;VALUE=DATE:20271210 SUMMARY:[COMP] COMP plenary meeting DESCRIPTION:COMP plenary: orphan designation opinions and orphan maintenan ce reviews at MA. Relevant for sponsors of rare-disease products.\nSource : https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ deadlines-submission-applications-orphan-medicinal-product-designation-em a-corresponding-comp-timetable-valid-applications-2026-2027_en.pdf\nhttps ://vigi-eye.com/calendar/2027-12-07-comp-comp-plenary-meeting URL:https://vigi-eye.com/calendar/2027-12-07-comp-comp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-12-08-cat-cat-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271208 DTEND;VALUE=DATE:20271211 SUMMARY:[CAT] CAT plenary meeting DESCRIPTION:CAT plenary on advanced therapy medicinal products (ATMPs): dr aft opinions and ATMP classifications. Relevant mainly for gene\, cell an d tissue therapy developers.\nSource: https://www.ema.europa.eu/en/docume nts/other/cat-meetings-2027-2028_en.pdf\nhttps://vigi-eye.com/calendar/20 27-12-08-cat-cat-plenary-meeting URL:https://vigi-eye.com/calendar/2027-12-08-cat-cat-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-12-13-chmp-chmp-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271213 DTEND;VALUE=DATE:20271217 SUMMARY:[CHMP] CHMP plenary meeting DESCRIPTION:CHMP plenary: new marketing authorisation opinions\, extension s of indication and SmPC changes are adopted. MAHs with pending procedure s should watch the highlights published at the end of the week.\nSource: https://www.ema.europa.eu/system/files/documents/other/final-chmp-dates-2 027-2028_en.pdf\nhttps://vigi-eye.com/calendar/2027-12-13-chmp-chmp-plena ry-meeting URL:https://vigi-eye.com/calendar/2027-12-13-chmp-chmp-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-12-14-pdco-pdco-plenary-meeting@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271214 DTEND;VALUE=DATE:20271218 SUMMARY:[PDCO] PDCO plenary meeting DESCRIPTION:PDCO plenary: paediatric investigation plans (PIPs)\, waivers and compliance checks are decided. Developers with PIP procedures should align submission timetables.\nSource: https://www.ema.europa.eu/bg/media/ 67738\nhttps://vigi-eye.com/calendar/2027-12-14-pdco-pdco-plenary-meeting URL:https://vigi-eye.com/calendar/2027-12-14-pdco-pdco-plenary-meeting TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-12-31-european-commission-mdr-end-of-transition-for-class-iii-and-implantab@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271231 DTEND;VALUE=DATE:20280101 SUMMARY:[European Commission] MDR: end of transition for class III and imp lantable IIb DESCRIPTION:Last day legacy class III devices and most class IIb implantab le devices can be placed on the market under the extended MDR transition\ , provided the 2024 application/agreement conditions were met. MDR certif ication must be in place after this.\nSource: https://eur-lex.europa.eu/l egal-content/EN/TXT/HTML/?uri=CELEX:32023R0607\nhttps://vigi-eye.com/cale ndar/2027-12-31-european-commission-mdr-end-of-transition-for-class-iii-a nd-implantab URL:https://vigi-eye.com/calendar/2027-12-31-european-commission-mdr-end-o f-transition-for-class-iii-and-implantab TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-12-31-european-commission-ivdr-end-of-transition-for-class-d-and-legacy-cer@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20271231 DTEND;VALUE=DATE:20280101 SUMMARY:[European Commission] IVDR: end of transition for class D and lega cy-certified IVDs DESCRIPTION:Last day IVDs holding a Directive 98/79/EC certificate and cla ss D IVDs without one may be placed on the market under the IVDR transiti on. IVDR certificates are needed after this date.\nSource: https://eur-le x.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401860\nhttps://vigi-ey e.com/calendar/2027-12-31-european-commission-ivdr-end-of-transition-for- class-d-and-legacy-cer URL:https://vigi-eye.com/calendar/2027-12-31-european-commission-ivdr-end- of-transition-for-class-d-and-legacy-cer TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-01-13-european-commission-hta-regulation-jca-scope-extends-to-orphan-medici@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20280113 DTEND;VALUE=DATE:20280114 SUMMARY:[European Commission] HTA Regulation: JCA scope extends to orphan medicines DESCRIPTION:Medicines designated as orphan medicinal products become subje ct to EU joint clinical assessment. Sponsors should plan JCA dossiers and PICO scoping alongside the MAA.\nSource: https://eur-lex.europa.eu/legal -content/EN/TXT/HTML/?uri=CELEX:32021R2282\nhttps://vigi-eye.com/calendar /2028-01-13-european-commission-hta-regulation-jca-scope-extends-to-orpha n-medici URL:https://vigi-eye.com/calendar/2028-01-13-european-commission-hta-regul ation-jca-scope-extends-to-orphan-medici TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-05-07-ispor-ispor-2028-national-harbor@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20280507 DTEND;VALUE=DATE:20280511 SUMMARY:[ISPOR] ISPOR 2028 (National Harbor) DESCRIPTION:ISPOR's annual international HEOR conference. Gaylord National Resort & Convention Center\, National Harbor\, Maryland.\nSource: \nhttp s://vigi-eye.com/calendar/2028-05-07-ispor-ispor-2028-national-harbor URL:https://vigi-eye.com/calendar/2028-05-07-ispor-ispor-2028-national-har bor TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-08-02-european-commission-ai-act-high-risk-rules-for-ai-in-regulated-produc@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20280802 DTEND;VALUE=DATE:20280803 SUMMARY:[European Commission] AI Act: high-risk rules for AI in regulated products (Annex I) DESCRIPTION:High-risk AI obligations apply to AI embedded in products unde r Annex I EU harmonisation legislation (which includes medical devices an d IVDs). AI-enabled device makers need AI Act conformity on top of MDR/IV DR.\nSource: https://ai-act-service-desk.ec.europa.eu/en/ai-act/timeline/ timeline-implementation-eu-ai-act\nhttps://vigi-eye.com/calendar/2028-08- 02-european-commission-ai-act-high-risk-rules-for-ai-in-regulated-produc URL:https://vigi-eye.com/calendar/2028-08-02-european-commission-ai-act-hi gh-risk-rules-for-ai-in-regulated-produc TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-10-29-ispor-ispor-europe-2028-copenhagen@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20281029 DTEND;VALUE=DATE:20281102 SUMMARY:[ISPOR] ISPOR Europe 2028 (Copenhagen) DESCRIPTION:ISPOR's European HEOR and market-access conference. Bella Cent er Copenhagen.\nSource: \nhttps://vigi-eye.com/calendar/2028-10-29-ispor- ispor-europe-2028-copenhagen URL:https://vigi-eye.com/calendar/2028-10-29-ispor-ispor-europe-2028-copen hagen TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-12-31-european-commission-mdr-end-of-transition-for-other-iib-iia-and-class@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20281231 DTEND;VALUE=DATE:20290101 SUMMARY:[European Commission] MDR: end of transition for other IIb\, IIa a nd class I (s/m) DESCRIPTION:Last day other legacy class IIb\, class IIa and certain class I devices can be placed on the market under the extended MDR transition\, if conditions were met.\nSource: https://eur-lex.europa.eu/legal-content /EN/TXT/HTML/?uri=CELEX:32023R0607\nhttps://vigi-eye.com/calendar/2028-12 -31-european-commission-mdr-end-of-transition-for-other-iib-iia-and-class URL:https://vigi-eye.com/calendar/2028-12-31-european-commission-mdr-end-o f-transition-for-other-iib-iia-and-class TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-12-31-european-commission-ivdr-end-of-transition-for-class-c-ivds@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20281231 DTEND;VALUE=DATE:20290101 SUMMARY:[European Commission] IVDR: end of transition for class C IVDs DESCRIPTION:Last day legacy class C IVDs without a Directive certificate m ay be placed on the market under the IVDR transition.\nSource: https://eu r-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401860\nhttps://vig i-eye.com/calendar/2028-12-31-european-commission-ivdr-end-of-transition- for-class-c-ivds URL:https://vigi-eye.com/calendar/2028-12-31-european-commission-ivdr-end- of-transition-for-class-c-ivds TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2030-01-13-european-commission-hta-regulation-jca-covers-all-new-medicines@vigi-eye.com DTSTAMP:20261114T053003Z DTSTART;VALUE=DATE:20300113 DTEND;VALUE=DATE:20300114 SUMMARY:[European Commission] HTA Regulation: JCA covers all new medicines DESCRIPTION:All centrally authorised medicines in scope of Article 7(1) be come subject to EU joint clinical assessment.\nSource: https://eur-lex.eu ropa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R2282\nhttps://vigi-eye .com/calendar/2030-01-13-european-commission-hta-regulation-jca-covers-al l-new-medicines URL:https://vigi-eye.com/calendar/2030-01-13-european-commission-hta-regul ation-jca-covers-all-new-medicines TRANSP:TRANSPARENT END:VEVENT END:VCALENDAR