New in Ennov InSight 7.3: Registrations

The new features and enhancements for Registration functionality are as follows.


Affected Area	Update	Benefit
Global Project Plan Wizard	The Global Project Plan wizard is updated with new fields when creating a sequence. See: Entity Fields and Columns Added: Ennov InSight 7.3	To maintain a new controlled vocabularies for quick and easy eCTD 4.0 specification updates in future, the sequence and other related submission options updates are introduced.
	The Global Project Plan wizard is updated with improved selection widget when creating active ingredients and substances. See: Entity Fields and Columns Updated: Ennov InSight 7.3	Improved selection widget capabilities with the updated data model enables simplified data creation.
Product Detail Sets (PDS)	To include the changes for IDMP, additional attributes and updates are made for the following: — Medical Devices: Medical Device > Medical Device Detail Attributes — PDS Package Set: Packaging > Package Detail Attributes Pack Size > Pack Size Detail Attributes See: — Entity Fields and Columns Added: Ennov InSight 7.3 — Ennov InSight Registrations > PDS Page: Medical Device PDS Attributes Package Detail Attributes Pack Size Detail Attributes	The ability to capture IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.


Affected Area	Update	Benefit
Medicinal Product Actions	Changes to IDMP also include updates for the following: — Medicinal Product Actions Attributes: • New DV icon is added. See: — Entity Fields and Columns Added: Ennov InSight 7.3 — Ennov InSight for IDMP > IDMP Data Visualization — Ennov InSight for IDMP > IDMP Data Visualization> Сolor Coding — Attached Document Attributes. See: — Entity Fields and Columns Removed: Ennov InSight 7.3 — Entity Fields and Columns Updated: Ennov InSight 7.3 — Ennov InSight Registrations > Attached Document > Attached Document Attributes	The ability to capture IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.
Product Detail Sets (PDS)	Changes to IDMP also include the new Intended Effect/Comorbidity sub-node in the Product Details in a PDS window. See: — Entity Fields and Columns Added: Ennov InSight 7.3 — Entity Fields and Columns Updated: Ennov InSight 7.3 — Entity Fields and Columns Deleted: Ennov InSight 7.3 — Ennov InSight Registrations > PDS Page: Product Details in PDS Associate an Intended Effect/Comorbidity Intended Effect/Comorbidity Attributes	The ability to track intended effects/comorbidities for the specific Indication and countries that are listed in the Indication/Intended Use Attributes page.
Affected Area	Update	Benefit
IDMP Data Generation wizard	To include the changes for IDMP, Ennov InSight 7.3 introduces the new IDMP Data Generation wizard. See: — Entity Fields and Columns Added: Ennov InSight 7.3 — IDMP Data Generation	The ability to capture IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.
XEVMPD Submission wizard	To include the changes based on the EMA specification for XEVMPD, the XEVMPD Submission wizard is updated. See: Entity Fields and Columns Removed: Ennov InSight 7.3	The ability to capture XEVMPD data in Ennov InSight in preparation for submitting XEVMPD data to EMA.