Transcript
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El orador presenta el tema del día: la función de submission en Dream y cómo se relaciona con el modelo de datos y los objetivos regulatorios. También introduce la idea general del flujo de submission dentro de la aplicación.
hey everyone how guys are doing I think you are doing good enough and you are enjoying the weekend so today uh I would like to more focusing on uh you know uh submission and how submission is working indream and as we have largely discussed about uh data model of preloaded information management system so today uh I can uh DT I can share mostly detail of you know submission feature and submission overview so uh with thatnote I am starting the slide for two days and uh who are watching my uh you know viewable uh recording uh they I think I I my goal is I want to you know uh provide some value whoare you know mostly focusing on viable and uh you know viewable application so uh thank you again that uh as you are watching my recording and and I'm very fast where I've started uh is Johnny uh in YouTube
and thanks a lot so today is our day 2 and at first and day one we have a disc mostly discuss about uh dream data model and today we will We would like uh I am like to discussmore about a submission feature and submission overview and uh here uh this is the flow where you can understand our application has two Wing uh one is submission and Regulatory objective and there are other related record ad aswell but application let's say you open a application for a particular leaked Country and this application uh when you open the application that then application in application you will find a submission and reg objective and as I alreadydiscussed the rig object is something uh which is which uh are need to achieve by uh submitting a submission to the health authority so this is a part of regulatory objective and submission and this is a a basic
flow of uh submission let's say or submission object sorry and uh there are a couple of uh point which uh you need to know about the submission and submission is something which is end-to-end application and it's designed uh
Se explican las características principales de submission, incluyendo content management, submission templates, modelo de datos personalizable y workflow de revisión. También se describe la estructura eCTD y sus módulos.
efficient management for regulatory content and it covers authoring review approval and assembly of various submission type and these are the key feature and what are those this one is content management other one is submission template other one iscustomizable data model and review workflow and this submission is also part of volt trip so what is content management so a Content management where you know P configured or predefined document type is there which uh based on thesubmission so let's say submission uh support non-clinical study clinical study quality so these are the document already defined uh under document type in Viva for uh achieving the submission purpose right and the submission template what is submission templateuh there are some PDF structured uh defined uh in submission based on that content plan uh need to be a Content plan attempted uh based on uh content plan template created based on that ecd format CD format is
supporting what FDA follow right so ecd format has a five module that I can show you uh let's say what is easy structure this is a CD structure and uh this is uh something uh recommended you know structurethat uh need to be used so in acidity you you can find a five module and under each module have a unique goal and unique purpose and let's say a module three contain a quality document uh quality documentand uh module 5 contain clinical study report and module 4 contained on uh clinical study report so that is how uh CD structure is like a pyramid and uh each section has a unique purpose so get back tothe topic again so this is all about acidity and next is customizable data model and installed are several related record so it has a customizable data model and review workflow offers Taylor app to process to ensure compliance that
means when you uh submit a submission for health authority uh so it follows some workflow and some life cycle uh to achieve the goal right and the submission also a part of full stream and it has a seamless
El enfoque pasa a las funciones clave como document type, content planning, report level content plan y publishing. Se detalla cómo los tipos de documento y el ciclo de vida ayudan a cumplir con los requisitos regulatorios.
experience so I'm moving to the next chapter on this topic which is uh you know a submission feature that container document type lifecycle workflow and Advanced Data model country and Market specific action content planning active and share viewerand editor report label content plan publishing so uh submission has several feature but one of the key features what I would like to uh uh discuss with you that is a document type and uh content planning report levelcontent plan and Publishing and another is lifecycle and workflow these are the important feature you can say so what is document type so here I took one of the screenshot from viva support and that is not a realcase uh there are some document which is include let's say clinical non-clinical quality regulatory pharmacovigilance so these are the document type for regulatory submission uh object is defined in Viva so this is p-configured you can say so a
volt offered a default document type subtype classification that align with regulatory submission requirement this include clinical non-clinical quality and Regulatory so here uh document type name is different as I told the screenshot I took uh you know foruh understanding purpose but there are that defined documentaries here in b y and life cycle and workflow uh is something and this is a you know a workflow structure I have given uh but uh in in submission uhlet's say there are some uh State planning uh send for health authority authority received so these are the life cycle we have uh in dream uh to uh to you know that this life cycle and workflow made forachieve the goal and achieve the goal means uh the submission need to send to hold the three right and this this bosses need to be checked and in each life cycle state right so uh that is the reason
Se profundiza en content planning como reemplazo de hojas de cálculo y en cómo se organiza el contenido para cada módulo del submission. Luego se explica el indicador de estado de publicación y cómo confirma que el contenido ya puede publicarse o importarse.
content planning so content planning is something where publisher they can planning the content and they can upload the correct document in each section is in each content plan item type and uh in dream uh submission content planning uhcustomer now can they can uh use a Content plan uh feature instead of spreadsheet because they are before they are using they were using the spreadsheet but now they can use the content planning too quickly to quickly createa list of all documents and they expect to call it as part of a submission but for submission let's follow the acidity format and for that format we need we have uh five module as I told and forfive module have a unique document need to be fulfilled I need to be uploaded right so that is all part of our content planning and uh if as I don't have that currently sandbox uh uh sandbox available in
my hand uh then I'm not able to showing you in practical but if anyone has that I can uh directly connect with them and I can guide them how content planning structure look like and uh now I'm movingto the next part there is a report level content plan and Publishing the report level content is something which is uh uh publishing outside of a submission let's say here in the content plan type there are several contentand quality Regional non-clinical clinical summary so report level content plan uh I have included uh as well in the last checkbox you are seeing you are now currently seeing that a report level plan non-clinical and clinical and thisis made for uh people uh create uh publishing or report level content plan so
indicator publishing status indicator is a something let's say uh your content plan uh is ready and uh your content plan has a Content plan item and match document uh and a document uh also update uploaded but uh youwill not able to and but whether the document will not publish until unless that uh validation or publishing job will complete right so after completing the validation job which is uh happening in backend in dream after accomplishing thatyou will get one uh indicator uh a green sign after seeing that you can understand okay my uh content plan is now ready for published or you can import the submission right so this is uh one of the
La charla termina con una invitación a hacer preguntas y a continuar la conversación sobre Dream y otras aplicaciones. Finalmente, el presentador cierra la sesión y se despide.
key feature of publishing status indicator and now uh my session uh already enclosed uh you know my topic has already been in the end now uh I just uh have a Q analysis uh uh session so here uhyou can ask any question if you have anything or you can uh you know comment uh me if you have any question or you can ask me in LinkedIn as well so if anyone want to know uh muchmore things about volt and old application uh let's say dream and clinical then uh I can uh able to share my experience with them and I want to uh and I I also able to uh try to addsome value to them and also uh similar and vice versa I can also get a value from them so with that note uh I'm finishing today's uh topic and I hope you guys are enjoying uh today's session and
we will I will catch up uh with you guys at um and someday with a new content and for now uh bye bye have a great rest of the weekend thank you see you soon bye