If you change organisation, you need to create a new account with new e-mail address via EMA Account Management Portal.The following actions should be taken if you need to change/update your e-mail address: To update your name, e-mail or any other details submit a request via EMA Service Desk.ĭue to improvements to EMA security and for more accurate interaction with EMA internal systems, users are no longer able to change/update their e-mail address via EMA Account Management Portal. You can change your mobile number by logging into the portal and making these changes in the " Edit Identity" area. To find out more about how to Create an EMA Account reference the guidance " Create an EMA Account". If you require an EudraLink account, you can request it via the EMA Service Desk after you have created an EMA account.Īccess 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. SPOR, Eudralink, EudraCT Secure, Service Desk portal, European Union telematics controlled terms (EUTCT), Meeting Management System (MMS), 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 (BI DASHBOARD), Corporate GxP database (CorpGXP), European Pharmacovigilance Issues Tracking Tool (EPITT) or Periodic Safety Update Repository (PSUR repository) If you have access to any of the following systems, you already have an active EMA account: To create an account only personal e-mail address must be used e.g. Gmail or Yahoo) e-mail addresses due to security reasons. Note: it may take some time before your account is active, so if you are not able to access your account immediately try again after 30 minutes. Wait for the confirmation e-mail before accessing other EMA applications. In case your email is already in use, retrieve your username here. You can create a new account by completing the Self-service Registration form. See the full list of procedural timetables.To be able to access EMA applications such as CTIS, SPOR, IRIS, EudraVigilance and UPD you need to have an EMA Account.Timetables are published as a generic calendar and are for the information and use of applicants, MAHs, the European Medicines Agency, CHMP, PRAC or CAT members and assessment teams. For full applications, see also the question on 'How should I notify a change in the intended submission date of my application?' in the pre-submission questions and answers. Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlinesĪpplicants should notify the Agency and the CHMP, PRAC or CAT rapporteurs and co-rapporteurs of their actual submission date. The Agency advises applicants to consider the date of submission very carefully, particularly for full applications, and to observe the joint guidance from EMA and Heads of Medicines Agencies below: The timing and planning of the submission of applications and the timetable for assessment of applications is important for applicants, marketing-authorisation holders (MAHs), the European Medicines Agency, and members and experts of the Committee for Medicinal Products for Human Use ( CHMP), the Pharmacovigilance Risk Assessment Committee ( PRAC) and the Committee for Advanced Therapies ( CAT).Timing applications appropriately enables the working plan to be as efficient as possible.
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