Who's Who
This is typically your client contact. They own the material and ensure it is review-ready. They represent at the review meeting and are responsible for making sure the material is used properly in the market with appropriate approvals
Who is Content Owner
This happens after Material creation
What is Material submission for QC
This is the portion of the code that's considered the Material code in the sample below:
MAT-US-2017668-v5.0-07/2022
What is MAT-US-2017668
This is what JRC stands for
What is Joint Review Committee
RC has approved your material with no edits, but you need to upload a clean version of the PDF without markups or annotations
Ready for Approval – Upload Content
They are responsible for shepherding the material through the review process and scheduling review meetings. They also capture all notes during meetings and route materials back to the CO or MC
Who is the Review Committee Process Leader/Coordinator
This happens after Material has been submitted.
What is QC
This is the portion of the code that lets you know what version you are using in the sample below:
MAT-US-2017668-v5.0-07/2022
What is v5.0
This is also a common name for PRB.
What is MLR or Medical Legal and Regulatory
RC has added annotations to the material that need to be addressed. A new version will need to be uploaded reflecting the edits requested, but the material is approved. This is typically for minor edits. The Content Owner will be the only follow-up review and the material can move forward once reuploaded
What is Ready for Approval with Changes
This is the Therapeutic Area Marketing Lead. They prioritize agenda items for review meetings and manages the escalation process if needed
Who is the Review Committee Chair
This occurs once QC has been approved
What is an RC Review
This is the portion of the code that shows you when the last update was made in the code below:
MAT-US-2017668-v5.0-07/2022
What is 07/2022
Utilized for products that are partially owned by your client and another brand (ex. Alliance – Sanofi + Regeneron)
What is JRC
RC requires extensive changes or a complete redesign of the material. You generally have five days to make the edits and resubmit
What is Revise and Resubmit
Individual responsible for assessing materials for any misleading content and compliance with regulations/company policies. They also ensure a balance of benefit vs. risk information
Who is US Regulatory
This is one of the 5 next steps after RC Review
What is either Embargo, Ready for Approval, Rejected, Revise and Resubmit, or Approved with Changes
The below is an example of how a job code would be structured in what circumstance.
DUP.23.02.0274 Last Update: March 2023
What is shared ownership between two companies.
Utilized for all content used in advertising, marketing, and promotion
What is PRB or MLR
Not a typical verdict, as most materials are able to be amended to comply with RC requirements.
Content Owner can escalate to the Executive RC for further examination or cancel the material entirely
What is Rejected
Individual responsible for scientific quality and objectivity of a material; ensuring data is accurate and contextually appropriate and that claims are substantiated consistent with the product labeling
Who is Medical Affairs Reviewer
These are the two approvals needed after Health Authority Review
What is Approved for Production and Approved for distribution.
These 3 names are common when describing Material Codes.
What is MAT codes, Job codes, and Veeva codes.
Ensuring a material is medically accurate, upholds all regulations, and complies with US Federal law while properly representing the brand/protecting the audience
What is JRC and PRB
Only used for materials submitted for new launch products prior to PDUFA.
Material cannot proceed until the launch date and must be held from further action
What is Embargo