With the 23R2 release, Vault now automatically populates Case Product Registrations and Case Assessments for domestic Cases and Localized Cases for Japan. In addition, a new action enables generating Localized Assessments for Products with the same Substance as a suspect or interacting Case Product when reporting to the PMDA. This feature ensures the proper selection of PMDA reportable Products and expedites the entry of associated information and J2 data elements. PMDA Local Case Processing Automations streamlines the reporting process and eliminates manual effort.
After configuring this feature, see the following for more information:
- To learn about configuring Case Assessment generation, see Set Up the Localized Business Admin Library for Japan.
- To learn about Japan Case Product Registrations on domestic Cases and Localized Cases, see Complete Intake and Process Cases for the PMDA.
26R2 Update: PMDA Comments Assistance
With the 26R2 release, to support compliant PMDA reporting, Veeva Safety adds more context for expectedness evaluations on Localized Cases for Japan. Vault now populates the reason for an expectedness evaluation, such as Unexpected Due to Seriousness, on Localized Case Assessments. Additionally, based on the Event (LLT) on a global Case, Vault now populates the Localized Event (LLT) on Localized Case Adverse Events. To configure your Vault for the updated feature, see (26R2) Configure PMDA Comments Assistance.
Update the Localized Case Assessment Layout
Add the following fields to the Localized Case Assessment section of Localized Cases:
- Case Product
- Case Product Registration
- Datasheet
- Datasheet Document
- Override Reason
Update the Localized Case Assessment Layout Rules
On the Localized Case Assessment object layout, create a layout rule to hide the Case Product Registration assessment fields for non-Japan Localized Cases. Complete the Create Layout Rule fields as follows:
- Label: Enter
Hide CPR Assessment Fields - IF this Layout Rule Expression is TRUE: Enter
localization__vr.name__v != "Japanese (Japan)" - Apply the following display effects:
- Effect: Hide
- Type: Fields
- Values:
- Case Product
- Case Product Registration
- Datasheet
- Datasheet Document
- Datasheet Document (unbound)
Configure the Retrieve Reportable Case Product Registrations Action on Localized Cases
To configure the Retrieve Reportable Case Product Registrations action, assign the action to the Localized Case object, and then add the action as a user action on the following Localized Case object lifecycle states:
- Active
- Revision
Update the Localizations Layout
Add the Assessment Generation field to the Localization object.
Configure the Japan Localization for Assessment Generation
Complete the following steps so that Localized Cases for Japan generate Localized Case Assessments based on Case Product Registrations:
- Navigate to Business Admin > Objects > Localizations > Japanese (Japan).
- Select Edit.
- In the Assessment Generation field, select Localized Assessments for Case Product Registrations.
- Select Save.
(26R2) Configure PMDA Comments Assistance
To configure your Vault for this feature for Localized Cases for Japan: