October 14, 2008 – Meeting Minutes

RPS R2 Requirements Subgroup Meeting

7:30 AM EDT – 9:00 AM EDT

Participants:

FIRST NAME / LAST NAME / COMPANY / EMAIL
Judith / Arcidiacono / FDA /
Scott / Becker / Merck & Co. /
dave / doleski / cber /
Daigoro / Ebina / PMDA /
Joel / Finkle / ISI /
Bill / Friggle / sanofi aventis /
Patty / Garvey / FDA /
Bob / Gatling / FDA /
Gary / Gensinger
Berhane / Girmay / FDA /
Mark / Gray / FDA /
Terry / Hardin / PerfiTech /
ellen / hodosh / astellas pharma us /
Wendy / Joarnt / Boston Scientific - CRM /
Brent / Jones / sanofi-aventis /
Brent / Jones / sanofi-aventis /
Raun / Kupiec / Genzyme Europe /
PEGGY / LEIZEAR / FTS-HHS FDA /
Klaus / Menges / BfArM /
Tracy / Naughton / AstraZeneca /
Tracy / Naughton / AstraZeneca /
Mary / Padgett / FDA /
Donald / Palmer / MedImmune /
Cindy / Piccirillo / Bristol-Myers Squibb /
Connie / Robinson-Kuiperi / FDA / constance.robinson-kuiperi
Jason / Rock / GlobalSubmit /
Karin / Sailor / Medtronic /
Leigh / Sandwell / Pfizer /
Joerg / Schnitzler / Wyeth Europa /
Benjamin / Schoenbrun / Booz Allen Hamilton /
Ted / Stevens / FDA /
Ed / Tripp / Abbott Labs /
Ken / VanLuvanee / Apyx /
Marti / Velezis / Sonrisa Consulting /
Virginia / Ventura / FDA /
Gary / Walker / quintiles - CDISC / Global data standar
Taku / Watanabe / PMDA /
Geoff / Williams / Roche /
JoAnn / Ziyad / FDA /


Agenda:

-  Review of Storyboards

-  Questions/Next Steps

The initial draft storyboards have been posted to the Wiki at:http://wiki.hl7.org/index.php?title=Regulated_Product_Submission_Release_2_%28RPS_R2%29_Storyboards

Notes:

Storyboards

Review of the Information about the Submission (need to flip the order of the storyboards).

·  Add a free text descriptor (comment field) – this was added to the ERD, but not the storyboards. Will need to update this in the storyboards. This should be a brief description (i.e., one or two sentences) to describe the purpose of the submission unit, which is also conveyed in more depth within the coverletter of the submission. This is a one-time description. The description should not be modified after receipt, as it belongs to the transmission of that submission unit. If anything needs to be modified, it will come in as another submission unit.

·  The three levels of submission number should be satisfactory for all regions and products for iteration 1.

·  Terminology is still an issue and we need to resolve the alignments of terms and meaning for the different regions before moving forward.

Two-way Communication

There was a question about how post-marketing commitment would be addressed (this item needs to be revisited).

Example of a submission unit would contain two meeting requests (i.e., correspondence), a presubmission meeting and a data meeting, that would potentially be tracked as separate correspondence.

Additional storyboards will need to be added, WG participants should contact M.Velezis to discuss any additional storyboards.