Transcript
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The speaker greets viewers and introduces the topic of VI registration and re-registration. They also reference a previous video on RIM for additional background.
hello everyone how are you I think you you guys are doing well and hopefully now the Christmas is coming so I think you will get a good time of you know uh good amount of time to spend withyour family and you know travel and roam around right so yeah so let's get started so today mostly I am going to discuss about you know uh VI registration process so last few days back uh I already uploadedto video regarding uh regulatory information management system from VI and how Rim is work and what is rim and what is the overview of Rim so if you not watch that two recording please uh you can watch whenyou are free right so today I'm going to be cover very specific topic that is our registration process re registration process and uh let's get started so re registra so the topic which I going to cover today that
This section explains what registration is, the main objects involved, and how they connect in the workflow. It also describes how events lead to related records like activities, applications, regulatory objectives, and submissions.
is re registration overview registration object and the feature of registration uh re registration overview B registration is uh into application for planning tracking and reporting of product and registration information management of health authority interaction and generation of productdata message so volt registration if I uh summarize some few point of volt registration so first is global solution for product and regulatory information and it is a single source for Global regisration and it manage manufacturing and levelingrelated change event and it handles activities which is associated for event response and detail medical product information so packaging doses form indication manufacturing specific these are all a medical product information right and integration with voltri so a registrationis part of the volt trim family and it is a single volt and it share a common data model and unique functionality for Effective regulatory Process Management so I'm going to the next Slide the registration object so mostly
in rim registration object contain registration event object activity object regulatory object application and submission so uh flow which I taken please uh check the screenshot here I added a key registration object so you already aare now what arethe key registration object one is event another is activity application regulatory objective submission and registration right so each object link with each other so even link with activity and activity also link with application regulatory objective submission and wholethat is linked with registration right so how the flow is work let's say a product need to be relabeled or a product needed some modification for a specific country so for that a event is created for a specificcountry and similarly from the event page a activity application regulatory objective and Par submission is created for the specific country and you can create in a bulk in Rim uh if you are not sure how to do that
I can I I'll share a link from viva uh there you can you know find how you can uh the whole registration process they have described so you can uh feel free to uh you know watch that recordingfrom as well at later right so here uh as I told from event uh for a specific event you can create a activity application regulatory object jective and submission and from regulatory objective you can control the registration so
The speaker defines events in more detail and distinguishes between global and local events. They also explain the role of activity and application as a centralized place for tracking registration work.
event what is that the what is event I already described you right the event is uh let's say a product modification or drug product modification required or a changes needed that is under event right and this event hasclassified one is a global event and another is a local event is based on the country right and activity so in the event what are the activity uh need to they need to perform right so that will becaptured under activity an application is a centralized folder there you can track event activity regulatory objective submission registration all those things that's why I called a centralized folder and Regulatory objective is uh for submission the submission that needto be sent to the whole health authority and for a specific submission there are couple of regular objective there so yep that's that's how the flow is work right and here in noted section I in I told that
I described that a activity is a child of event object track the specific country or change in a specific Market based on the parent so here there are couple of registration feature I have added so volt registration is
This chapter covers the main features of VI registration, including the advanced data model, regulatory event management, and bulk data creation. It also shows how records can be created from an event page and linked to applications.
built on volt platform and that include the feature described in the platform help Topic in addition it include this capability and configuration specific to managing product and device information so there are a couple of feature uh I canshare all the link uh you can uh go through in detail but here uh I'm just added very specific term and very specific uh term terminology so yeah so one is Advanced Data model and it really Advanced Datamodel because you know registration object is contain event activity and registration object it's included several object like event activity submission regulatory objective application so this is the advanc data model and manage regulatory event so and next is generatea history of registration data and provide an affiliate specific user inter so affiliate user no need to you know go through each and every individual object so there are a specific tab there uh in a page so from
that page affiliate user can control event activity regulatory objective and registration right and next is use regulatory objective data as Source in manage register details wizard so each and every registration details uh data will be tracked under thereport so uh let's be specific spefic about Advanced Data model so why it's called Advanced Data model because it buil on strong industry based practice and ISO idmp and imdrf Udi standard so what is idmp idmp is asuit uh of five standard developed within uh International Organization for standardization to faciliate the unique identification of medicinal product handle complex relational product and regulatory information and its very easily extensible for custom Data Tracking so that's why it'sa Advanced Data model and another is manage regulatory event so volt registration provide the ability to manage and track regulatory event regulatory approval manufacturing changes level changes so as I already informed what event is event is something which
need to be modified one is regulatory approval manufacturing changes level changes is all part of event quickly assess the impact of plan changes and take action B provide bulk data creation so it will reduce the you know ummanual effort so bold provider B data cre creation functionality tailor specifically for Rim registration which allow efficient creation of submission activity and Regulatory objective for each event so from event page you can able to create submission activity andRegulatory objective and uh you can link with application so it's very efficient Tool uh so I'm going to the next feature one is uh as I told that b creating activity submission and regular objective from event page sohere I took one of the screenshot so you can see from the test event de three section from here you can uh create record like activity submission regulatory objective and that you can link with application so that will
The final section explains lifecycle tracking and historical reporting for registration data. The speaker closes by emphasizing the importance of registration in RIM and inviting questions and comments.
minimal your effort and you can create a necessary record from the event object right so yep so I'm going going to the next topic and and next feature so manage the life cycle of detailed product information so organizationcan capture manage and track detail related to life cycle of product and their Associated registration so that you already know right so in a registration it going to going through the specific life cycle and that will be capturedso generate history of registration data user can generate a historic view of registration data where you can uh understand that how the the audit of the registration record so how the registration is going through what are the changeshappened during the life cycle right so that all are that all are captured if you uh generate a historic report history view of regist data to support regulatory requirement with this report user can view a history of all
registration changes globally so this is all about a registration object and registration feature and the registration is a very primary thing in regulatory information management system of Viva so if you have any question please feel free to uhadd in the comment section and I'll share the Nary link of via product and you can check the registration product demo from the Via site and stay tuned for the next video bye-bye