Ema service desk. Jun 13, 2024 · The European Commission is reviewing the rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for human medicines. It is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and other organisations working on clinical trials. EMA Service Desk (system support) Services and databases. already listed in the EMA’s Organisation Management Service (OMS) (see section Organisation registration in OMS (SPOR)) otherwise you will not be able to affiliate yourself to an organisation and request the appropriate IRIS user access role in the EMA Account Management Portal. eu/ for your password to be reset. Sep 16, 2013 · EMA Service Desk (system support) Services and databases. These will be communicated via a Service Desk, as in other systems managed by EMA in the following link EMA's general Service Desk. If you do not have an EMA Account, you may create one via the EMA Account Management portal. Jul 12, 2021 · The Union Product Database (UPD) serves as a single source of information on all authorised veterinary medicines and their availability in European Union (EU) and European Economic Area (EEA) Member States. 14-10-2024. Search our knowledge base or submit a ticket. The European Medicines Agency (EMA) set up and maintains the veterinary medicines information website and the Union Product Database, in collaboration with the Member States and the For any further information, please contact EMA Service Desk. The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. 2998. Learn how to use the online portal to report issues, request services or ask questions about EMA systems. Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities. 00am to 5. Official support hours for the EMA Service Desk are Monday to Friday, from 07:00 to Mar 12, 2023 · In case the previously indicated person of contact and/or submission date of an upcoming application for marketing authorisation is changed, the applicant shall inform the EMA by raising a ticket via EMA Service Desk, selecting the tab “Business Services”, category “Human Regulatory”. Table of Contents. You can create a new user account, apply for user access roles, reset your We would like to show you a description here but the site won’t allow us. Registered users can also see notice of any planned interruptions in EMA Service Desk. EMA customer account number Applicants must have a valid EMA Customer Account Number. In case of any further technical queries, please contact us at: https://servicedesk. The survey is open until 31 October. I'm afraid we can't tell you who they might be. In case users do not have credentials for CTIS, they can call the EMA Service Desk telephone number: +31 (0) 88781 7523. Planned maintenance of eSubmission systems on 8 October 2024, 18:00 CET. md will be your Sandbox url. In Greek mythology, Iris was a messenger to the Gods who carried the “Caduceus”, or staff, now found at the centre of the international symbol for medicine. Apr 5, 2022 · This explains how to proceed if the Q&A documents do not provide the answers to potential Type II variation submission questions. This is a dedicated page, serving as a comprehensive repository of essential links to Guidance Documents and Training Session on Product Management Service (PMS). Users who have received notification of successful completion can train other users within their organisation. Have a question or business inquiry? Contact us here or call 561. The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Its objective is to develop and implement standards and technical guidance documents for the submission of electronic information in the context of European approval The first step to access EudraVigilance is to be registered with the EMA Account Management portal (IAM). Aug 13, 2019 · You will need to contact whomever is behind your Eudralink and/or EMA Service desks. If you do not find the substance you need, please register it by completing the “Substance Request Form” and raising a request via the EMA Service Desk portal, for the substance to be included in the SMS database, attaching the Substance Request EMA Service Desk (system support) Services and databases. Authorisation of these pandemic vaccines is faster than a normal vaccine, because EMA assesses the information submitted by the manufacturer in an accelerated timeframe, taking around 70 'active' days instead of the usual 210. The service aims to provide timely pre-submission guidance to facilitate the validation of these post-authorisation applications. Using the EMA Service Desk • In the EMA Service Desk Portal you can choose from the below categories: • EudraVigilance to report on medical literature monitoring, duplicates or request quality assurance test. European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands. Article 57(2) of Regulation 726/2004 If you cannot find the support you need in the guidance documents, please contact the EMA Service Desk. To do so, the active substance(s) in the product must be already registered in the EMA public list of all substances 3. If you experience any issues with the online registration please contact: EMA service desk already listed in the EMA’s Organisation Management Service (OMS) (see section Organisation registration in OMS (SPOR)) otherwise you will not be able to affiliate yourself to an organisation and request the appropriate IRIS user access role in the EMA Account Management Portal. Jan 7, 2009 · For more detailed queries on technical matters please contact the EMA Service Desk. eu/ By Telephone: For urgent technical matters, telephone +31 (0) 88 781 8520 {"tourEnabled":false,"wacLink":"https://www. +31(0)88 781 6000 (EMA switchboard) Tel. In case your “active substance” is not registered you will need to raise an EMA Service Desk request and attach a completed form to register a new “Substance” The emergency procedure allows for fast-track approval of a new vaccine developed once an influenza pandemic is declared. These may be found on the eAF pages of the EMA’s eSubmission website. The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network. Mar 2, 2020 · EMA Service Desk (system support) Services and databases. ©1995-2024 European Medicines Agency | Disclaimer |For technical support, please visit the EMA Service Desk (ServiceNow) portal using your user credentials for a system hosted by EMA (except Eudravigilance). LOCATION: 4700 Exchange Court, Suite 225, Boca Raton, FL. You can create a new user account, apply for user access roles, reset your EMA Service Desk (system support) Services and databases. Improving the availability of medicines authorised in the European Union (EU) is a key priority for the European Medicines Agency (EMA) and the European medicines regulatory network. . Below you can find the full release notes and a list of any outstanding issues and proposed workarounds for these issues. From the end of September, to access Eudralink, you must sign on by entering your EMA username For general inquiries, please contact the ePI team via ePI@ema. Electronic product information (ePI) ePI on the PLM Portal streamlines product information management, enhancing data accessibility, accuracy, and collaboration across the product lifecycle. com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm EMA Service Desk (system support) Services and databases. It is likely that you already have an EMA Account Management portal account if you have access to at least one of the following EMA systems: EudraLink, EudraCT Secure, IT Service Desk portal For technical support, please visit the EMA Service Desk portal; I am from a national medicines regulatory authority or pharmaceutical company and have a question about accessing the EudraVigilance system for professional purposes Submit your question via the EMA Service Desk portal; For all other questions or queries If you cannot find the support you need in the guidance documents, please contact the EMA Service Desk. Service Desk Operations Team Jun 18, 2024 · EMA Service Desk (system support) Services and databases. Marketing authorisation holders of medicines in the European Economic Area (EEA) are usually responsible for monitoring the medical literature on their medicines, and reporting individual cases of suspected adverse reactions into EudraVigilance and The medical literature is an important source of information for the identification of suspected adverse reactions to authorised medicines. The subcategory to be selected is “Pre-Submission You can see when we are planning the next outage below. We advise that you keep the email containing the PDF attachment in an appropriately secure location for future reference. eu Q. Planned maintenance of the Common Repository Torrent in the evening of 21 March 2024 contact the EMA service desk via the online portal https://servicedesk. Submission of Type IA/ IAIN Variation Notifications Release Notes for the specific form. This is a unique reference number for financial matters and is required to submit parallel distribution notifications. com. ema. an RPI; it is reviewed and approved by the EMA 2. ; XCOMP mirrors the EudraVigilance production environment and allows organisations to test the submission of individual case safety reports (ICSRs) and extended EudraVigilance product report messages (XEVPRMs). You can create a new user account, apply for user access roles, reset your To sign in, you need an active EMA user account with the necessary user access roles. Eudralink while you contact EMA’s IT Service Desk to resolve MFA set up issues We advise you to complete the above steps well in advance of 29 September 2023, when the traditional Eudralink login method will be disabled. com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm For support with submitting information on an authorised medicine, you can use the online EMA Service Desk portal or call +31 (0)88 781 8520 for urgent technical matters. If the data volume is large, they can send the data (valid E2B (R3) XML files) to EMA via physical media (CD-ROM or DVD). You can create a new user account, apply for user access roles, reset your Reach out to us to share your feedback and compliments on our service quality. 15-03-2024. How: After having created an EMA account via the EMA Account Management portal; the MAA pre-submission interactions form (available here, at the bottom of section 2. To registerfor the knowledge evaluation, submit a request to EMA Service Desk. What is ePI? What are the Key Principles for ePI? What is the EU ePI Common Standard? What is the ePI pilot project? Information management is a critical enabler of the European Medicines Agency's (EMA) mission to promote and protect public and animal health. The eSubmission Gateway and the eSubmission Gateway Syncplicity Web Client are electronic submission channels that allow the applicants to submit documents supporting all types of applications for human and veterinary medicines to the Agency securely over the internet in structured and non-structured formats. 9 under “references”) shall be filled in electronically and sent to the EMA template, by raising a ticket via EMA Service Desk, using the Question option “Pre-Submission Phase EMA Service Desk (system support) Services and databases. Access to SPOR as an unaffiliated user (not linked to an organisation) will be granted automatically on self-registration to EMA Account Management to allow requesting the creation of an organisation in OMS. Are you having trouble with using CTIS? Check the system requirements and recommendations for optimal use of CTIS. Alternatively, if you are unable to access the EMA Service Desk, please send an email directly to servicenow@ema. EMA invites small and medium-sized enterprises (SMEs) and industry stakeholders to complete an online survey on the EMA's support, incentives, and services for SMEs. EMA Account Management Portal ; How to Create a New EMA Account ; Keywords: Account management Guidance and support EMA Service Desk Legal EMA Service Desk (system support) Services and databases. The feedback gathered will help EMA to understand current issues and better tailor future activities to their needs. Add Ticket To sign in, you need an active EMA user account with the necessary user access roles. 30pm, Mondays to Fridays. Access and manage your EMA account to utilize applications like IRIS, eAF, and EudraVigilance for medicine-related services. 1. eu. 7. The subcategory to be selected is “Post-authorisation - Human”, followed by the sub-option “Variation IB A&B scopes queries Jan 27, 2023 · EMA Service Desk (system support) Services and databases. In case this is unknown, please submit a request to EMA service desk. The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of form, etc. servicedesk. New issues may be raised via the EMA service desk, quoting “eAF” in subject (https://servicedesk. Functional mailboxes replaced by the EMA Service Desk From 1 February 2016, the EMA Service Desk portal replaces the below functional email addresses which were previously used to support users of the associated EMA systems: The contact details of EMA systems previously supported by these mailboxes will be updated to provide users with a link The EMA Service Desk can provide remote support when you are teleworking, including: for all applications on your laptop, if you are teleworking using your laptop and you are able to connect to the internet; assistance over the phone, whenever possible. eu Learn how to log into EMA systems using different authentication methods, such as email, username, password, or multi-factor authentication. IT Service Management (ITSM)? Often, businesses will use the terms ‘help desk’ and ‘service desk’ interchangeably. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the View Ema Radočaj’s profile on LinkedIn, the world’s largest professional community. It is requested to contact the "EMA Service Desk" with the question, the type of question and the corresponding sub-criterion, in this case "Post-Authorisation queries" and "Variation II scopes (Non clin/Clin/RMP)". {"tourEnabled":false,"wacLink":"https://www. com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm Eudralink, EudraCT Secure, service desk portal, European union telematics controlled terms (EUTCT), meeting management system (MMSe), managing meeting document system (MMD), EudraVigilance data analysis system (EVDAS), EudraPORTAL, European Union good manufacturing and distribution practices database (EUDRAGMDP), paediatrics records application (PedRA), SIAMED business intelligence dashboard EMA Service Desk refers to the customer support service provided by the European Medicines Agency (EMA). innerhalb von vier Stunden eine Eingangsbestätigung erhalten. Contact. May 14, 2024 · 2024/10/17 - MAHs to prepare for PMS edit function in support of shortage monitoring Aug 8, 2024 · This user guide describes how to navigate across the pages of the PMS product user interface (PUI), and how to access, search and export PMS authorised product data. This concerns the Commission Regulation (EC) No 1234/2008 together with the variations guidelines within the existing legal framework of Regulation (EC) No 726/2004 and Directive 2001/83/EC. This becomes even more confusing when one introduces ITSM. This video will walk you through the key capabilit Jan 7, 2009 · EMA Service Desk (system support) Services and databases. +31 (0)88 781 6000 (EMA-Telefonzentrale) Updated documentation will be published on the relevant pages of the eSubmission website. If you require an EudraLink account, you can request it via the EMA Service Desk after you have created an EMA account. It allows MAHs to receive specific regulatory guidance on planned applications and to discuss any pre-submission questions with an EMA procedure manager before submitting an application. The request needs to be done on an official headed paper from the HQ organi sation, adding all the necessary information for the merge: organi sation name and ID of the profiles to become affiliates, and organisation name and ID of the profile to become or remain as HQ, and signed by the responsible person Nov 10, 2023 · 在计划递交MA前18个月-7个月，通过EMA Service Desk递交资格申请 (Eligibility request)，随后Committee for medicinal products for human use (CHMP) 开会讨论，一般20-25天有反馈。 Step 2：预约递交. You should receive an acknowledgement in four hours during EMA business hours. Service Desk Lead for TEAMTACLAN · Experience: EMA · Education: Strayer University · Location: Gibsonton · 105 connections on LinkedIn. request a merge via EMA Service Desk. 申请人在计划提交日期前的7个月，通过EMA Service Desk提交Pre-submission request form, 提出MAA预约。 requests. Service Desk Lead EMA Dec 2008 - Present 15 years 7 MAILING: 4850 T-Rex Avenue, Suite 200, Boca Raton, FL 33431. For example, if mypractice. Apr 8, 2022 · Level up your IT help desk operations with featrues from Intel® Endpoint Management Assistant (Intel® EMA). eu If you cannot find the support you need in the guidance documents, please contact the EMA Service Desk. SPOR data management services. To sign in, you need an active EMA user account with the necessary user access roles. EMA's Management Board endorsed this approach on 19 December 2019, based on a recommendation by EMA's Pharmacovigilance Risk Assessment Committee (PRAC). This is driven by the increasing importance of interconnected information technology (IT) systems for managing and sharing information on medicines, the growing range of EMA's external users with different information requirements and the overall EudraVigilance is the data-processing network and database for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area (EEA). eu). com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm For technical support, visit the EMA Service Desk portal: https://support. * Airtime charges may be imposed by service providers for mobile calls made to 1800 local toll-free numbers. 01-10-2024. Expanded Access EMA’s Community-Based Organization (CBO) program combines the SAO and the application fee waiver process to provide students and access organizations with a simple, one-stop option. +31(0)88 781 7676; Outside of EMA business hours, use the following urgent contact number: Tel. This allows EMA to manage the substance data. +31(0)65 008 9457 Jan 7, 2009 · If you cannot find the answer to your question in the Q&A when preparing your application, please raise a ticket via the EMA Service Desk, selecting the tab “Business Services”, category “Human Regulatory”. Ist dies nicht der Fall, können Sie sich unter folgender Telefonn ummer mit der EMA in Verbindung setzen: • Tel. To help stakeholders prepare for this new requirement, EMA will update the EU ICSR Implementation Guide and provide face-to-face and online training, including webinars, to address technical Jan 31, 2022 · EMA Service Desk (system support) Services and databases. The Iris, or “Blue Flag”, is a plant used in healing and medicine since ancient times. If you cannot find the support you need in the guidance documents, please contact the EMA Service Desk. Please specify if your request concerns knowledge evaluation for authorised medicinal product data or development medicinal product data or both. Ema has 5 jobs listed on their profile. Your best option, if you can't find docs in the stuff you do have access to, is to ask other people around who. Contact the friendly EMA support team for help with family accounts, SSAT, Standard Application Online (SAO), and the Character Skills Snapshot. 880. Webex Help Center: Join a Webex meeting; Webex Help Center: Use the Webex meetings mobile app; Quick Webex guide: Best practices for meeting participants (video) If you need more help, please contact your EMA contact point or the EMA Service Desk. eu indicating your name, surname and your unique username and we will help you with your access request. The medical literature is an important source of information for the identification of suspected adverse reactions to authorised medicines. com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm EMA Service Desk portal or call +31 (0)88 781 8520 for urgent technical matters. Get Ebook What is IT service desk vs. For access on your iPad, install the ModMed Practice Sandbox app and log in using your Sandbox url. {"tourEnabled":false,"wacLink":"https://www. Shortages or other problems with the availability of medicines create challenges for the medicine supply chain, potentially seriously impacting human and animal health. Tel: +31 (0)88 781 6000. Pu rpose and Context This guide aims to support the users of the PLM Portal - PUI in completing the steps needed to gain access to the platform to manage authorised products data in PUI. The CTIS sponsor handbook covers priority topics identified with the help of clinical trial sponsors, with references and links to further supporting materials. Jun 29, 2023 · In alignment with the EMA’s information security strategy, a new IT service management solution called ServiceNow will replace the current tool (JIRA) for CTIS User Support Service (USS) requests, starting on 31 July 2023. EMA is a decentralized agency of the European Union responsible for the evaluation and supervision of medicinal products. 14. The EMA is pleased to announce that the non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal. Marketing authorisation holders of medicines in the European Economic Area (EEA) are usually responsible for monitoring the medical literature on their medicines, and reporting individual cases of suspected adverse reactions into EudraVigilance and internally. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap. The European Medicines Agency is a decentralised agency of the European Union responsible for the evaluation, supervision and safety monitoring of medicines. For support in connecting to the EV Gateway, contact EMA EV Gateway administrator at: Help Desk tel: 44 (0) 20 7523 7523 email: gatewaysupport(at)ema. 33431 • (561) 880-2998 The EMA is pleased to announce a series of webinars for SPOR and XEVMPD scheduled from 04 to 14 October 2024. com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm To sign in, you need an active EMA user account with the necessary user access roles. We provide contacts for general enquiries and technical support for users of the secure workspaces of the Clinical Trials Information System (CTIS), such as clinical trial sponsors and other organisations involved in running clinical trials, national competent authorities {"tourEnabled":false,"wacLink":"https://www. Jan 9, 2009 · EMA Service Desk (system support) Services and databases. Users The Human Harmonisation Group (HHG), is a subgroup of the eSubmission expert group and is made up of representatives from National Competent Authorities, the EMA and Industry. Non-Centrally Authorised Products now available in the PLM Portal eAF. 2. com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm if they wish to change from Webtrader to Gateway, they must raise a Service Desk request to make the change and add the corresponding documents. • Service Desk to report technical issues, request a service or ask a technical question relating to EudraVigilance or a specific EMA Service Desk Portal • Update of EMA’s Service Desk ticketing system • Accessing EMA’s Service Desk portal • Two-factor authentication • Accessing EMA’sService Desk via mobile app Before using the Service Desk Portal Using the Service Desk Portal • Ask a Question, Request a Service and Report an Issue related to EV {"tourEnabled":false,"wacLink":"https://www. For questions or comments around the content of this Q&A document, please raise a ticket via the EMA Service Desk. Explore these resources to gain valuable insights and practical knowledge, empowering your understanding of PMS. europa. For further information or guidance about how to create an EMA Account reference the guidance "Create an EMA Account". Closed on Weekends and Public Holidays. If you do not, you can phone EMA on: Tel. ematraining. The portal replaced the functional mailboxes from 1 February 2016 and offers user-friendly, transparent and trackable service management. 16. An addition was also made to Chapter 16 in the answer to question 16. EMA will manually process these files. "When and how will the RMP Summary be published on the EMA website?" The new versions of the "Q&A" documents for centralised procedures can be found on the EMA website Mar 11, 2009 · EMA Service Desk (system support) Services and databases. • Senden Sie das Formular per E -Mail (qdefect@ema. The first iteration of the SMS, in 2019, enabled users to request the registration of a new substance term or the update of an existing substance term through EMA Service Desk. eu indicating your name, surname and your unique username, and we will help you with your access request. IT help desk vs. 2998 x2 or email support@modmed. md is your EMA url, then mypractice. eu) an die EMA. If I need to access products data in PMS on behalf of more than one ORG ID, shall I submit separate requests in IAM? No, as announced at the SPOR status update webinar on 10 April 2024, users can submit in a single To access your EMA sandbox login on your computer, simply add the word “training” after “EMA” in your unique practice URL. atlassian. EMA maintains this website in collaboration with the EU Member States and EEA countries, and the European Commission. Some functionalities within CTIS rely on other systems which are also maintained servicedesk. EMA SPOR Regulatory Data Management services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, efficiencies and more efficient regulatory action. " Chapter 16 Risk Management Plan. For any further information, please contact EMA Service Desk. Apr 17, 2023 · EMA Service Desk (system support) Services and databases. Need EMR user support? Call 561. The European Medicines Agency’s (EMA) Service Desk provides a dedicated, online helpdesk for clinical trial sponsors and regulators requiring technical support with using CTIS. Sie sollten während der Geschäftszeiten der EMA. Find out how to request, change, or view your authentication settings and possible errors. As per the EU pharmaceutical legislation . com/software/jira/service-management?utm_medium=jira-in-product&utm_source=jira_service_desk_portal_footer&utm eSubmission Gateway and eSubmission Web Client . Feb 13, 2024 · The letter of intent should be attached to the EMA Service Desk ticket. 3. Quality Service Manager Line: 1800 734 9177* Operating hours: 8. Not sure if you have an EMA account? Forgot Password? Forgot Username? {"tourEnabled":false,"wacLink":"https://www. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the protection of public health in the European If the data volume is small, they can use Eudralink to submit the valid E2B (R3) XML files to an email address provided by EMA in response to their EMA Service Desk request. We would like to show you a description here but the site won’t allow us. EMA operates a full-time customer service center to support families and provides training and instructions to support EMA member schools. lrvki xbtg wkmok lbnpf pdbwk vnizpe uakoxrp adjvc ainrw gqbcc