![]() Please do not resend documents that have not been modified.ġ.3. In the case of validation issues, the additional and modified files should be sent to the Agency using the eSubmission Gateway or eSubmission Web Client. The Agency will appoint one of its scientific officers as paediatric coordinator after receipt of the full application, unless a pre-submission meeting is requested (see below). The Agency and the PDCO no longer accept CD or Eudralink submissions. Read the summary of changes in xml delivery file for paediatric submissions introduced on 19 November 2020. On naming conventions and file formats published on the eSubmission Gateway and eSubmission Web Client\paediatric submissions page, and submit the application according to the published submission deadlines and in line with User Guidance for submissions via eSubmission Gateway / Web Client using xml delivery files. July 2021įrom January 2018 EMA only accepts applications submitted via the eSubmission Gateway / eSubmission Web Client. To whom and how should I submit the PIP or waiver application? Rev. See further information under point 1.1 in Guidance on paediatric submissions.ġ.2. Applicants are therefore advised to obtain the RPI number well in advance of any planned submission. Paediatric Committee (PDCO) plenary meetingsįrom 10 October 2021, an RPI number will be mandatory for paediatric investigation plans (PIPs), modifications of agreed PIPs, and requests for waivers. Submission deadlines for paediatric applications 2021-2024 Submission deadlines are outlined in the following document: Template for scientific document (part B-F) Late submission of the PIP or waiver application should also be justified in also referred to as Part A - the date of completion (last patient last visit) of the last basic PK study in adults.įailing to provide a date of completion of PK studies in adults should be justified. Practical advice on completion of the application form (part A)Įlectronic form for paediatric-investigation-plan application and request for waiver Submitting a PIP application for a new active substance during confirmatory or phase-III trials in adults, or after starting clinical trials in children, is likely to be considered unjustified. Applicants are welcome to submit their PIP applications during or even before initial PK studies in adults. The timing of submission should not be later than the end of healthy subject or patient PK, which can coincide with the initial tolerability studies, or the initiation of the adult phase-II studies (proof-of-concept studies) it cannot be after initiation of pivotal trials or confirmatory (phase-III) trials. It is appropriate to set a deadline for the submission of a PIP in order to ensure early dialogue between the sponsor and the Paediatric Committee’. ![]() Recital 10 of the Regulation states that ' paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population, where appropriate, before marketing authorisation applications are submitted. home/we/norns/lua/core/engine.According to Article 16 of the Paediatric Regulation, applications should be submitted, unless duly justified, 'not later than upon completion of the human pharmaco-kinetic (PK) studies', as specified in Section 5.2.3 of Part 1 of Annex 1 of Directive 2001/83/EC. home/we/norns/lua/core/a:129: in field ‘init_done’ ![]() home/we/norns/lua/core/a:193: in field ‘set_mode’ home/we/dust/code/a:24: in function ‘redraw’ home/we/dust/code/a:24: attempt to index a nil value (global ‘scree’) Pset > write: /home/we/dust/data/system.pset script run (“code/a”) script load: /home/we/dust/code/a cleanup script clear ![]() Here’s a very basic script containing a typo on line 24 - scriptname: short script description If somebody wants to test on Fates maybe… Has anybody noticed that too or does it happen only with my setup ? I’m not sure yet but I think it happens only if the mistake is done within the redraw() function. I’m often making a small typing mistake (or worse) when writing scripts in Maiden and this generally leads to an «attempt to index a nil value », but i think it used to go back to normal immediately after fixing the typo and without requiring a reboot. I mean that it goes back to the main screen displaying the name of the script but the buttons and encoders become unresponsive.Įven if I fix the mistake and run the script again in Maiden, the only way of getting back to normal is to reboot the Raspberry Pi. If I make a typo in a script, for example writing screnn.move(20,30) instead of writing screen.move(20,30) this immediately breaks everything. Oh, there’s one more thing I’d like to mention, it’s unrelated to the previous issue ![]()
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