Migrating Data to Veeva RIM Registrations

The primary use case for a Veeva Registrations migration is a legacy migration. A Registrations migration commonly involves migrating data, correspondence documents, and source documents. This guide covers the most common aspects of migrating data to a Registrations Vault.

Migrating Registrations Data

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The Veeva RIM product model offers some flexibility with how data is modeled.There are certain reference objects that are used by the application and any associated document. For Registrations customers, these objects consist of the reference product hierarchy and application objects.

Registration Objects

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• Registration
• Registered Detail
• Event
• Activity

IDMP and xEVMPD Objects

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• Administered Product
• Administered Product Active Substance
• Administered Product Inactive Ingredient
• Administered Product Route of Administration
• Coded Indication (from MedDRA dictionary)
• Regulatory Objective
• Medicinal Product
• Medicinal Product Classification System
• Medicinal Product Coded Indication
• Medicinal Product Full Name
• Medicinal Product Name Part
• Medicinal Product Administered Product
• Medicinal Product Registration
• Product Cross Reference

Note

The European Medicines Agency (EMA) leads the implementation of the ISO IDMP standards in the EU through its Substance, Product, Organisation, Referential master data programme (SPOR) and the EU Implementation Guide (EU IG). You can find details on how these standards work in regulatory practice, guidance documents, timelines, and technical requirements on the EMA website.

Packaging Objects

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• Packaging
• Containers
• Physical Characteristics
• Shelf Life
• Components
• Others

You should give special consideration when migrating Packaging, Registration, Activity, Health Authority Interaction and IDMP/xEVMPD records.

Considerations

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Packaging

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You should review the relationship between Packaging and Product and Product Variant records. A US-based application utilizes the Product Variant, whereas EU applications under the centralized procedure pull Packaging records related to Product Variants or Complex Products.

Registration

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After creating the Registration record, you should associate it with the other reference records by creating the appropriate detail records:

• Registration Regulatory Objective
• Registered Product
• Registered Packaging
• Registered Organization

Registered details can be created and updated via a wizard. This is either from the Create Registrations wizard on the Application or the Manage Registered Details wizard on the Regulatory Objective.

Activity

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You must create Activity records after creating their related Events.

Application

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See the Registration-specific Application considerations.

Regulatory Objective

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See the Registration-specific Regulatory Objective considerations.

Submission

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See the Registration-specific Submission considerations.

IDMP/xEVMPD

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If implementing IDMP, you must populate additional metadata and objects.

Depending on what functionality is already live and volume of data needed for migration, you must consider whether IDMP Accelerators should be enabled before or after migration.

You should import labelling documents prior to xEVMPD and IDMP go-live.

Health Authority Interaction

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Health Authority Interactions are typically implemented as part of the Submissions implementation.