Module 12 Presentations

PV Tool Field name

RIM Field Name

Product Family Name

Pharmacovigilance Use Case: Signal detection & Safety reporting

Product Family name

Trade name

Product name

Substance Name Inactive Ingredient

Ingredient(s) name

Presentation Strength Lower Ranger Value Concentration Strength Lower Ranger Value Presentation Strength Lower Range Unit Concentration Strength Lower Range Unit

Ingredient(s) Dose

Enable capability to exchange of information between RIMS and PV tooling to quicker identify potential signals for products and apply ISO IDMP identifiers as part of E2B(R3) within the safety reporting. • PV tools should describe products according to IDMP standards • Same usage of SPOR-terminology between systems • Data-flow between PV tool and RIM • Assess what data elements are shared between RIM and PV tool

Ingredient(s) Unit

N/A

Generic Name

Manufactured Dosage Form

Dosage formulation

Name

Dosage Strength

Name

Dosage Units

Primary Indication of product Full Indication Text Product International Birth Date International Birthdate

Development International Birthdate

Product Development International Birth Date

Manufacturer

Product Manufacturer

Invented Name

Product Trade Name

Registration Holder

Product License Market Authorization Holder

Country (although this will be the actual countries even for CP products)

Product License Authorization Country

Registration Type

Product License Type

Procedure Type

License approval type (Applicable for EU licenses)

Product License Award Date Registration Start Date Product License Withdrawn Date Registration End Date Product License Datasheet N/A

Legal Status of supply (but does not indicate if biologic or vaccine)

Product type

Renewal Required Last Renewal Date

Renewal information

The Organisation for Professionals in Regulatory Affairs

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