DESD PSS: Regulated Product Submission Update from RCRIM
Return to Domain Experts Electronic Voting Summaries
Please vote on the PSS for the RCRIM WG. Enter your name and WG along with your vote. 1 vote per WG. Poll open until 11/29/2011 unless quorum is reached earlier. Link to Document: Regulated Product Submission Project Scope
- Summary - Passed (6/0/2/6)
- Number of participants: 8
- Most popular option: Affirmative
- Votes in favor: 6
- Comments: 6
- Non-participating work groups counted as abstaining solely for the purpose of counting quorum: 0
| Co-Chair (WG) | Affirmative | Negative | Abstain |
| Jim McKinley (AWG) | OK | ||
| Melva Peters (Pharmacy) | OK | ||
| John Roberts (PHER) | OK | ||
| edward helton (RCRIM) | OK | ||
| Helmut Koenig (II) | OK | ||
| Dianne Reeves (CIC) | OK | ||
| Mead Walker (PSG) | OK | ||
| John Rhoads (DEV) | OK | ||
| Count | 6 | 0 | 2 |
Comments
| Name | Date | Comments |
| Melva Peters (on behalf of Pharmacy Work Group) | Monday, November 28, 2011 2:10:52 AM GMT-12:00 | "The Pharmacy Work Group reviewed your response to our comment on your RPS Project Scope Statement.
We believe that there is likely more overlap between the RPS processes and the IDMP processes than you believe, however, we are willing to change our negative vote on the PSS. We do strongly suggest that you monitor the ongoing work on the IDMP project and consider it, along with the CPM, in your work." |
| Ed Tripp (for Joel Finkle) | Monday, November 21, 2011 5:19:41 AM GMT-12:00 | "Part 1 of 3
Product metadata is present in the RPS model only to enable some regulators to use it for managing submission routing/workflow; it is not intended to describe a product in any detail. We drew on CPM because it was already worked out but we used only a small subset of classes and retained only the name attribute on the two key entities, product and substance, so our dependence on CPM is very weak and does not extend in any way to IDMP." |
| Ed Tripp (for Joel Finkle) | Monday, November 21, 2011 5:18:18 AM GMT-12:00 | "Part 2 of 3
Note that a regulatory submission may well contain instances of CPM and/or IDMP messages, as a regulator may require, but the RPS standard does not extend to the specification of how submission content is encoded and is therefore not dependent on RCRIM standards that apply only to submission content." |
| Ed Tripp (for Joel Finkle) | Monday, November 21, 2011 5:17:26 AM GMT-12:00 | "In short, the high-level product description attributes we use from CPM are extremely unlikely to be in any conflict with IDMP, and would not interact with the processes of IDMP.
RPS's use does not include description of the product beyond the point of identifying what products are being reviewed/approved -- e.g. which of the three applied-for strengths, or which variations on pacemaker leads -- become approved products." |
| Mead Walker | Monday, November 21, 2011 2:59:55 AM GMT-12:00 | It is important to ensure that product and product identification information uses the structures of the Common Product model to guarantee consistency with the IDMP work. It is not completely clear from the document that this will be ensured. |
| Melva Peters (Pharmacy) | Wednesday, November 9, 2011 2:32:16 AM GMT-12:00 | I note that while there is a potential dependency noted for Common Product Model, there is no dependency identified for the Identification of Medicinal Products (IDMP) project currently underway in Pharmacy. We believe that this work must be included as a dependency for this project as much of it will be a subset of the RCRIM processes |
