Ennov InSight Registrations 7.3

Registration Planning and Tracking Queries

The Query links related to registration and planning are defined under Registration Planning and Tracking tab. One row per entity is returned.

For easy reference, the query descriptions are arranged alphabetically by query name.

List of Application Countries with Registration Details

The List of Application Countries with Registration Details query enables you to view countries that are associated with applications or registrations that have specific attributes. The query can be one of the following, based on your security privileges:
  • For Submission Planning and Tracking module users, the query contains application, associated countries and event information. Registered countries and PDS (Product Detail Sets) are not available.
  • For Registration Planning and Tracking module users, the query contains registration attributes, application, application countries, event and registration attributes. PDS information is not included.
  • For Product Detail Management module users, the query contains application, application countries, event, registration, and product detail set detail information.

List of Applications with Products

The List of Applications with Products query enables you to view all applications that have a combination of application attributes, for example, all applications in the top 20 countries for a product family. The query returns all application attributes and products associated with the application. One row of data is returned per application/product/component combination. This query applies for all the application types.

List of CTA Applications

The List of CTA Applications query enables you to view clinical trial authorization applications, the countries in which the related product is being tested, and the development sponsor for the clinical trial. You can limit the returned applications to those that are in a specific product family, have a specific status, and are associated with a clinical trial that has a specific development sponsor. 

List of Events with Application Properties

The List of Events with Application Properties query enables you to view events that have specific attributes and are associated with applications that have specific attributes, for example, all initial approvals for the year or all non-notified events. The query returns all events attributes and some application attributes.

List of Events with Change Details

The List of Events with Change Details query enables you to view events that have specific attributes and are associated with change, change type, or change detail. You must have at least Read rights for Entity Security -> Change to view the report.

List of IND Applications

The List of IND Applications query enables you to view a list of all IND applications, the application attributes, the associated CT shared data, and the related comparators. You can limit the returned IND applications to those that have a specific status, Periodic Safety Update Report (PSUR) due date, or PSUR lock date.

List of Manufacturers from Data Administration

The List of Manufacturers from Data Administration query enables you to view manufacturers. The query returns one row per product detail associated with the manufacturer satisfying the criteria.

List of Medical Device Products

The List of Medical Device Products query enables you to view medical device products associated with the product families you specify. You can choose only product families whose type is medical device. The query enables you to view the following:
  • All products for a selected EU class
  • All withdrawn products

List of Medical Device Products and Components

The List of Medical Device Products and Components query enables you to query medical device products and their components that are associated with a product families you specify. You can choose only product families whose type is medical device. The query enables you to view the following:
  • All medical device products in Calyx RIM
  • All/specific products and components for a product family
  • Components and product attributes for a selected product
  • All the components for a specific component manufacturing location

List of Pharmaceutical and Medical Device Products

The List of Pharmaceutical and Medical Device Products query enables you to view pharmaceutical-medical device combination products associated with the product families you specify. You can choose only product families whose type is pharma-med device. The query enables you to view the following:
  • All products for a selected EU class
  • All withdrawn products

List of Pharmaceutical Products

The List of Pharmaceutical Products  query enables you to view pharmaceutical products associated with the product families you specify. You can choose only product families whose type is pharmaceutical. The query enables you to view the following:
  • All withdrawn products
  • Products that have not been updated for a year
  • All active products in a selected therapeutic class

List of Pharmaceutical Products and Components

The List of Pharmaceutical Products and Components query enables you to view pharmaceutical products and their components that are associated with the product families you specify. You can choose only product families whose type is pharmaceutical. The query enables you to view the following:
  • All/specific products and components for a product family
  • Components and product attributes for a selected product
  • All the products and the components that contain a specific active ingredient
  • All the components for a selected component manufacturing location

List of Pharmaceutical and Medical Device Products and Components

The List of Pharmaceutical and Medical Device Products and Components query enables you to view pharmaceutical-medical device combination products associated with the product families you specify. You can choose only product families whose type is pharma-med device. The query enables you to view the following:
  • All pharma-medical device products in Calyx RIM
  • All/specific products and components for a selected product family
  • Components and product attributes for a selected product
  • All products and components that contain a specific active ingredient
  • All components associated with a selected component manufacturing location

List of Product Families

The List of Product Families query enables you to view the product families that have a combination of product family attributes, such as all product families with the same therapeutic area or product families that contain an active ingredient you specify. The query returns all product family attributes.

List of Products with Event and Product Registration Details

The List of Products with Event and Product Registration Details query enables you to view the product family type for the related products and their associated events that are being tracked on a registration. The query enables you to show the following:
  • The associated application name and code
  • Details about the associated event, including the event-product status, status date, and EU worksharing/grouping status
  • The license code, status, and status date for the associated registration

List of References

The List of References query enables you to view references that have a combination of reference attributes, for example, all non-regulatory correspondence with a specific agency. The query returns all reference attributes.

List of References - Rollup by Application

The List of References - Rollup by Application query enables you to view all references that are directly or indirectly associated with an application that you specify. For example, all non-regulatory correspondence associated with an application. The query returns all reference attributes.
Note: Product and product family references are not included.

List of References - Rollup by Product Family

The List of References - Rollup by Product Family query enables you to view all references that are directly or indirectly associated with a product family that you specify. For example, all non-regulatory correspondence associated with a product family. The query returns all reference attributes.

List of References - Rollup by Project

The List of References - Rollup by Project query enables you to view references that are directly or indirectly associated with a project that you specify. The results are limited to references directly associated with the project or event, and references associated with applications and sequences that are indirectly associated with the project.

List of Registrations for a Product Family

The List of Registrations for a Product Family query enables you to view all registrations for products that are in a specific product family and have a specific registration status. This query returns registration attributes for the specified product family.

List of Registrations with Application Properties

The List of Registrations with Application Properties query enables you to view registrations for applications that have specific attributes, for example, all registrations for Europe for a product family and a specific application status. This query returns all registration attributes and some application.

List of Sequences with Application and Event Properties

The List of Sequences with Application and Event Properties query enables you to view sequences that have specific attributes and are associated with applications and events that specific attributes, for example, all planned submissions or amendments submitted in the past year that had to do with toxicity. This query returns all sequence attributes and some application and event attributes.

List of Tasks

The List of Tasks query enables you to view tasks that have specific attributes, for example, all overdue tasks or all upcoming commitments. This query returns all task attributes.

List of Tasks - Rollup by Application

The List of Tasks - Rollup by Application query enables you to view tasks that are directly or indirectly associated with an application you specify, for example, all tasks associated with an application. This query returns all task attributes.
Note: Product and product family tasks are not included.

List of Tasks - Rollup by Product Family

The List of Tasks - Rollup by Product Family query enables you to view tasks that are directly or indirectly associated with a product family you specify, for example, all tasks associated with a product family. This query returns all task attributes.

List of Tasks - Rollup by Project

The List of Tasks - Rollup by Project query enables you to view a list of tasks that are directly or indirectly associated with a project that you specify. You can limit the returned tasks to those that have attributes that you specify. The query shows all attributes of the returned tasks.

List of Veterinary Products

The List of Veterinary Products query enables you to view veterinary products associated with the product families you specify. You can choose only product families whose type is veterinary. This query shows the following:
  • All withdrawn products
  • Products that have not been updated for a year
  • All active products in a selected therapeutic class or dosage form

List of Veterinary Products and Components

The List of Veterinary Products and Components query shows veterinary products and their components that are associated with the product families you specify. You can choose only product families whose type is veterinary. This query shows the following:
  • All/specific products and components for a product family
  • Components and product attributes for a selected product
  • All the products and the components that contain a specific active ingredient
  • All the components for a selected component manufacturing location

PSUR World Wide Marketing Authorization Status

The PSUR World Wide Marketing Authorization Status query shows events that have the PSUR flag set to yes and that satisfy the criteria you specify, for example, registration activity that has occurred for a product family. This query returns each country/event with PSUR reporting attributes.
Note: You can export this query to RTF or Microsoft Excel™ to support PSUR reports. Also, users who do not have security privileges for an application country can see that country in the PSUR World Wide Marketing Authorization Status report. However, they will not be able to navigate to entities that are not permitted by their specified security privileges.

XEVMPD Submissions - QC Verification and Audit

The XEVMPD Submissions - QC Verification and Audit query shows all XEVMPD data associated with a particular Authorised Product for QC assessment. You can also see historical data for each of the XEVMPD fields associated with an Authorised Product, including:
  • XEVMPD data mapped with a particular Full Product Presentation is correct
  • Data mapped with a particular Full Product Presentation is ready to be submitted
  • Last person to modify XEVMPD data
  • Last time the XEVMPD data was updated
Note: You must have the Calyx RIM for XEVMPD license to access this query.

XEVMPD Submissions and Acknowledgements

The XEVMPD Submissions and Acknowledgements query shows the XEVMPD acknowledgement files information, including 3rd Acknowledgement Types with the description of the proposed changes from EMA. Use the XEVMPD Submissions and Acknowledgements to find:
  • If there is an XEVMPD acknowledgement for a submitted XEVMPD XML file
  • If there are any issues reported by EMA authority for the XEVMPD XML file sent
  • If there are any errors and the changes required to provide to EMA authority for the XEVMPD XML file sent
  • The acknowledgements received for a particular XEVMPD XML file
  • The acknowledgements received in general from EMA authority for your XEVMPD files
Note: You must have the Calyx RIM for XEVMPD license to access this query.