Difference between revisions of "Product (RPS)"
Joelfinkle (talk | contribs) (New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== TBD. Definition may be ...) |
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==R1 Working Definition== | ==R1 Working Definition== | ||
| − | TBD. Definition may be coming from other areas, e.g. HL7 Common Product Model. However, it must meet RPS2 needs, such as general administrative references ("what product is this message about?"), labeling, overall life-cycle, etc. Generally agreed that it should also be as simple/small as possible to accomplish this. There is a need to have multiple Products per [[Submission (RPS)|Submission] (and therefore [Submission Unit (RPS)|Submission Units]). Not in RPS1]. | + | TBD. Definition may be coming from other areas, e.g. HL7 Common Product Model. However, it must meet RPS2 needs, such as general administrative references ("what product is this message about?"), labeling, overall life-cycle, etc. Generally agreed that it should also be as simple/small as possible to accomplish this. There is a need to have multiple Products per [[Submission (RPS)|Submission]] (and therefore [Submission Unit (RPS)|Submission Units]). Not in RPS1. See also [[Regulated Product (RPS)|Regulated Product]]. |
==ICH Equivalent== | ==ICH Equivalent== | ||
Latest revision as of 18:42, 19 September 2008
This is a Glossary page
This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized
Contents
R1 Working Definition
TBD. Definition may be coming from other areas, e.g. HL7 Common Product Model. However, it must meet RPS2 needs, such as general administrative references ("what product is this message about?"), labeling, overall life-cycle, etc. Generally agreed that it should also be as simple/small as possible to accomplish this. There is a need to have multiple Products per Submission (and therefore [Submission Unit (RPS)|Submission Units]). Not in RPS1. See also Regulated Product.
ICH Equivalent
Drug-Product associated with a Dosage Form and Manufacturer(s)
BRIDG Term
Product
A thing produced by or resulting from a process.
For example, a drug or device.
For example, the FDA list of regulated products: animal and human drugs; therapeutic biologics; allergenics; cell, tissue and gene therapy products; blood components; blood derivative products; devices; and animal (pets and livestock) and human food/feed (medicated and unmedicated); cosmetics; pet treats; and dietary supplements.
