September 29th, 2022 Drug Content Analysis Project Group Launch

Reminder to record call!

Declaration of conflict of interest

NONE

Introduction of the project 

Scope, goals: identify clinical drug concepts that exist in extension models of participating NRCs that are eligible for promotion with appropriate reference to authoritative source material, to the international edition.

Requirements to be considered:

Training and support from internal authors;

Level 1 authoring course completed;

Identified patterns for terming of FSNs and PTs;

Agreed process to source appropriate references

Monica and Julie introduced the project.

Selection of co-chair

Hanne Fjeldstad Johansen, Norwegian NRC has been appointed.

Potential Content submissions 

Participants volunteered potential content submissions were UK, Norway, US 10,000 clinical drugs.

Need to explore technical and authoring solutions to the management and remodelling of this content.

Norway has created a process for validating the concepts.

This may or may not be modelled as per the National extension guidelines. 

Australia has substance, dose form and unit of measure concepts to submit but these may be out of scope for this project.

Approach to the process

• Identify area of hierarchy to tackle first

• How we get a batch input 

• How to verify - need editorial policy 

BAU CRS REQUESTS ARE PERMITTED AND SHOULD CONTINUE. 

Experience from Norway - sometimes need to check multiple SPCs.

Can have multiple interpretations of one single drug product. 

If no SPC, then cannot accept into International release. 

Upcoming Calls and Events

Monthly with exact date to be decided.

Initial meeting with co-chairs will occur first to establish some meeting times.