Calyx RIM Administration

Product Family Maintenance: Product Family Values

You can create and maintain the following product family values:
Value Description
ATC EU-specific Pharma Anatomical Therapeutic Chemical class code. The list contains ATC codes from the EMA ATC Code Additions CV. The default value is set to Active. The standard set of extra fields can be configured for this value.
Division Related to the Office of Device Evaluation (ODE) Review Divisions, for example, Division of Cardiovascular, Respiratory and Neurological Devices, Division of Clinical Laboratory Devices, etc.
Product Family Status The status of the product family, such as investigational, planned, approved, active, withdrawn.
Product Family The highest level of a product defined by the company-based user-defined product family code and/or name.
Substance Attachment Used to include attachment related values such as: attachment name, file name, file type, attachment version, attachment link, attachment language, EV (EudraVigilance) code, and comments. This attachment type is Printed Substance Information (PSI). The standard set of extra fields can be configured for this value.
Substance Class Classification given to substances. Examples are mixture, and specified substance classes. The list contains substance classes and substance class code from the EMA Substance Class CV. The default value is set to Active. The standard set of extra fields can be configured for this value.
Substance Define substances values with their affiliated attributes. The XEVMPD related substance entities such as substance alias, substance attachments, substance international codes and substance translations can be added using the Substance option. Several types, such as Substance, Placeholder, and Strain, can be selected from the list. The default type value is Substance. The list contains the substances from the EMA Substances CV. The default value is set to Inactive. The standard set of extra fields can be configured for this value.
Therapeutic Area Therapeutic use, such as oncology, cardio-renal, pulmonary. The standard set of extra fields can be configured for this value.
Therapeutic Class Groups of similar drugs used to treat a specific condition. The standard set of extra fields can be configured for this value.
Trade Name The name under which a company markets a drug.

ATC Attributes

To define an ATC value, enter values for the following attributes:

Attribute Description
ATC Code Standard Code defined by the EMEA used to identify Anatomical Therapeutic Chemicals (ATC).

ATC is a classification system for drug substances which is maintained by the WHO Division of Drug Management and Policies (DMP).

ATC Description Name of the Anatomic Therapeutic Class assigned by the EMEA.
Term Type Type of ATC term. Examples: Development Term, Proposed Term, Standard Term
ATC Level Level of the ATC Code. The field can be used to track the level of the ATC.
Version Date Only needed for dev and proposed terms for XEVMPD.
Development Type Acknowledged This field is needed for the application. It is not specified by the EMA. Values available for selection: Yes/No. Default is No
Proposed Type Acknowledged This field is needed for the application. It is not specified by the EMA. Values available for selection: Yes/No. Default is No
Date Submitted to EMA Date Submitted to EMA populated automatically when Acknowledgment Wizard passed.
Last Updated Date Last Updated Date populated automatically when updates were made to the table.
RMS Term Name List of Active ATC RMS Values must be available for selection.
Comments Comments associated with the ATC.
XEVMPD Comments Comment field.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Division Attributes

To define a division value, enter values for the following attributes:

Attribute Description
Division Relates to the Office of Device Evaluation (ODE) Review Divisions. Examples: Division of Cardiovascular, Respiratory and Neurological Devices; Division of Clinical Laboratory Devices; Division of Dental, Infection Control and General Hospital Devices; Division of General and Restorative Devices; Division of Opthalmic Devices; Division of Reproductive, Abdominal, Ear, Nose and Throat Radiological Devices
Default Flag Flag to indicate if the product status is the default.Yes and No values are available for selection.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Product Family Status Attributes

To define a product family status value, enter values for the following attributes:

Attribute Description
Name The name given for the Product Family Status.
Default Flag Flag to indicate if the product status is the default.Yes and No values are available for selection.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Product Family Attributes

To define a product family value, enter values for the following attributes:

Attribute Description
Product Family Type Type of Product Family. Examples: Pharmaceutical, Flu Vacine, Veterinary, Medical Devices, Pharma-Med Device
Family Code Code of Product Family.
Family Name Name of Product Family.
Product Family Status Status of Product Family. Example: Active, Planned
Product Family Status Date Status Date of Product Family.
Development Sponsor Development Sponsor value in following concatenation MAH/Development Sponsor/Organisation Name + Address + City + Country Code.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Substance Attachment Attributes

To define a substance attachment value, enter values for the following attributes:

Attribute Description
Attachment Name Type of Product Family. Examples: Pharmaceutical, Flu Vacine, Veterinary, Medical Devices, Pharma-Med Device
File Name File Name of the attachment. User should manually populate the file extension. The User will have an ability to modify the name manually.
File Type Type of file. Values available for selection are: pdf, doc, docx, xls, xlsx
Internal Name The Name of the Attachment indicates the Internal Company name for the Attachment.
Attachment Version The version of the PSI attachment.
Attachment Version Date Attachment Version Date.
Attachment Link Link to the Document.
Country Active Country Names from Country values in Data Administration.
Attachment Language Active Language Codes from the Languages values in Data Administration.
Date Submitted to EMA Date Submitted to EMA populated automatically when Acknowledgment Wizard passed.
EV Code Official EV Code assigned by the EMA. This code is mandatory for all operation types, except Insert.
Comments Comments field.
Development Sponsor Development Sponsor value in following concatenation MAH/Development Sponsor/Organisation Name + Address + City + Country Code.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Substance Class Attributes

To define a substance class value, enter values for the following attributes:

Attribute Description
Substance Class Name Classification given to a substance. Examples: Mixture, Single, Specified Substance (must be specified for an Insert or Update operation)
Substance Class Code Code assigned to the substance class.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Substance Attributes

To define a substance value, enter values for the following attributes:

Attribute Description
Type Defines the type of each Substance value. The values available are: Substance, Placeholder, and Strain
Substance Name Name of the Substance. Combination of Substance Type + Substance Name should unique in the system.
INN International Non-proprietary name.
CAS Number Chemical Abstract Services number assigned to the Substance.
Molecular Formula Chemical formula of the substance.
Compound Number
XEVMPD Development Substance Identifies the substance as a Development Substance.
Substance Level Class All active Substance Level Class Values from Data Administration.
CBD Chemical Biological Description of the Substance.
Development Sponsor Sponsor of the Clinical Trials if this is a Development Substance. Required by XEVMPD if this is a Development Substance in following concatenation MAH/Development Sponsor/Organisation Name + Address + City + Country Code
Compendial Designation/ Source Compendial Designation/ Source. Substance Source in XEVMPD.
Keywords Free format text box where users can enter text for searching purposes.
Description Free format text box for entering descriptive information.
Comments Free format text box where users can enter information.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Therapeutic Area Attributes

To define a therapeutic area value, enter values for the following attributes:

Attribute Description
Therapeutic Area Name Full Therapeutic Area Name. Example: Oncology, Anti-Inflammatory
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Therapeutic Class Attributes

To define a therapeutic class value, enter values for the following attributes:

Attribute Description
Therapeutic Class Full Therapeutic Class Name. Example: Oncology, Anti-Inflammatory
Therapeutic Class Code Code used to define Therapeutic Class.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Trade Name Attributes

To define a trade name value, enter values for the following attributes:

Attribute Description
Trade Name The trade name given.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.