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* Project Status - Ballot update | * Project Status - Ballot update | ||
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Ballot Update: RPS R2 Ballot materials were sent in to HL7 Publishing | Ballot Update: RPS R2 Ballot materials were sent in to HL7 Publishing | ||
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* Need to validate the eCTD Granularity Document with the current standard (R1/R2) to ensure that this requirement has been validated. Need to follow-up with testing activities and/or implementation projects to ensure this is tested. | * Need to validate the eCTD Granularity Document with the current standard (R1/R2) to ensure that this requirement has been validated. Need to follow-up with testing activities and/or implementation projects to ensure this is tested. | ||
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[[Media:Scope Prioritization 24112009.pdf]] | [[Media:Scope Prioritization 24112009.pdf]] | ||
Latest revision as of 18:49, 24 November 2009
Return to RCRIM main page | Regulated Product Submissions
Date: November 10, 2009
Time: 7:30 AM EST – 9:00 AM EST
HL7 Telecon: 770-657-9270 Participant Passcode: 745896
Contents
Agenda
- Project Status - Ballot update
- RPS R3 Scope Prioritization Discussion
- Questions/Other Topics?
Notes
Ballot Update: RPS R2 Ballot materials were sent in to HL7 Publishing
RPS R3 Scope Prioritization Discussion:
- Updated the spreadsheet distributed.
- The group completed the prioritization and complexity rankings for all of the high-level scope topics.
- There are some additional requirements that have been received that need to be assessed whether or not they are new requirements or if they are inclusive in the ICH requirements.
- There are quite a few implementation requirements that are included in the ICH list of requirements that need to be collected and worked on with an implementation group in the future for R3. Although there is nothing in the message to be added for these requirements, it is important that the information in the message provide the appropriate information for the validation and integrity checks needed in an implementation of the standard.
- Need to discuss the Master File requirements. Is there any business need to call out any additional information about the Master File reference (currently just a reference from one application to another)? Is the COU for Right to reference Letter sufficient? Note that the Sponsor/Applicant will only be able to reference the application number for legacy submissions (i.e., non-RPS or electronic content submission). Is there a requirement to call out the relevant section referenced? or is it document, submission specific?
Other
- Need to validate the eCTD Granularity Document with the current standard (R1/R2) to ensure that this requirement has been validated. Need to follow-up with testing activities and/or implementation projects to ensure this is tested.
Next meeting - the meetings are rotating between 7:30 AM EST and 12:00 PM EST; need to canvass participation for the 12:00 PM EST meeting due to the international focus of the R3 Scope content. Will send updates to group.
Attachments
Media:Scope Prioritization 24112009.pdf
Participants
Pending complete list
