Generics+--+1-13-09+minutes

** January 13, 2009 ** ** Meeting minutes were accepted and there were no questions. **   If you are not an existing D&B customer you can contact Julie Newman to set up an account for SPL DUNS#s only. Julie Newman Please note: One item from the Leadership team meeting is that the FDA is recommending that each company which does not have a gateway account already should obtain one ASAP. Link here: __http://spl-work-group.wikispaces.com/Electronic+Submission+Gateway+%28ESG%29 __    ** Generic Sub Team Attendees  ** ** For meeting 1/13/09  ** Generic Sub Team Leader || Teva Pharmaceuticals || Virginia.Hogan@tevausa.com || Generics Sub Team Co Leader || RA/IT Associates || JMKarp01@comcast.net ||  ||  ||  || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> ||
 * Agenda for SPL Generic Sub Team Meeting **
 * 1)  Meeting minutes from 12/15/08 – are posted on the Wiki site – any questions, additions, etc?
 * 1)  Reminder - beginning in January we will meet every 4th Tuesday.
 * Nothing to add  **
 * 1)  Tom Marsden, Ryan Paul & Julie Newman/D&B presentation & Q&A session.
 * Tom Marsden, Julie Newman, and Ryan Paul were on the teleconference. Dun And Bradstreet is still working on a solution to get the D-U-N-S numbers out. D&B is working with vendors as well as up-staffing for this.  **
 * When we contact D&B, they would like to update their information about the company that is contacting them. This will help keep the information current. **
 * Remember the D-U-N-S numbers is being used as part of the information to validate the SPL submission. **
 * Regarding costs – these are still not determined. For D-U-N-S numbers inside the corporate family tree, these numbers are not charged for. External one are charged for but the price points are not fully determined. **
 * Again, there are three methods of getting trading partner information: **
 * D&B will be at the Face-to-Face meeting in May. **
 * The SPL group still needs **
 * ** the cost structure  **
 * ** a definition of corporate family tree  **
 * ** speed of response and turn-around of request  **
 * ** for trading partner information that exists  **
 * ** for trading partner information that has to be generated  **
 * ** a quick way to find who in the sponsor company is responsible for the D-U-N-S numbers; whether it is a purchasing, legal or other department  **
 * Many other questions were asked. Most of these should be in the FAQ. See: **
 * http://spl-work-group.wikispaces.com/DUNS+Number+FAQ **
 * <span style="color: black; font-family: 'Tms Rmn','serif'; mso-bidi-font-family: 'Tms Rmn';">Do it!!! **
 * 1) <span style="font-family: 'Tms Rmn','serif'; mso-bidi-font-family: 'Tms Rmn';">FDA Training webinars and F2F meeting May 21, 2009. SPL Vendor training webinar 02/04/09.
 * 1) <span style="font-family: 'Tms Rmn','serif'; mso-bidi-font-family: 'Tms Rmn';">Prototype stylesheets from SPL R3 & R4.
 * 1)  OTC vendor webinars – we will keep you informed.
 * Please see the Wiki for presenters, dates and times. Also there are copies of the presentations on the Wiki at: **
 * http://spl-work-group.wikispaces.com/OTC **
 * at the Vendor Presentations sub-head. **
 * 1)  Companies registered electronically will now have their DUNS numbers on the site.
 * 1)  Questionnaire on Wiki site – Jeffery Karp. (PDF of Survey attached.)
 * The PDF of the survey is on the Wiki on the Generics page. Jeffery Karp described the survey and how to use it. **
 * Note: Post the meeting, a note was sent out inviting you to take the survey. Please do this and let us know your information and any comments you have on the survey. **
 * 1)  Any other business.
 * **<span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Name ** || **<span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Company ** || **<span style="font-size: 11pt; font-family: 'Helv','sans-serif';">E-mail ** ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Blik, Cheryl || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Cheryl.Blik@tevausa.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Brandt, Richard || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">InVision Research || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">RBrandt@invisionresearch.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Brunone, Theresa || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Glaxo Smith Kline || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Theresa.Brunone@gsk.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Cekic, Fatima || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Caraco Pharm Labs, Ltd || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1845� �1700��1335��1336��1337��1338� Cobham, Michele || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Par Pharmaceutical || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Michele.Cobham@parpharm.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Desai, Mona || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Interchem || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1846� �1706��1351��1352��1353��1354� Fariman, Denise || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Lannett Company, Inc. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">DFairman@lannett.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Frahn, Jane + 1 team member || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Jane.Frahn@tevausa.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Harvey, Mary || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">MHarvey@qualitestrx.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Hewitt, Michele || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1847� �1718��1383��1384��1385��1386� Hogan, Virginia
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Karp, Jeffery
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Keller, Jamie || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Glenmark Generics, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial; mso-bidi-font-size: 10.0pt;">JamieK@glenmark-generics.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Kirkeleit-Davis, Jean || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Hospira || <span style="font-size: 11pt; font-family: �1848� ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Kirkner, Ruth || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Ruth.Kirkner@tevausa.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Lee, Koung || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">FDA, Office of Generic Drugs || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Koung.Lee@fda.hhs.gov ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Lempka, Gayle || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Watson || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Gayle.Lempka@watson.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Mohammed, Suraya || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">GPhA || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1849� �1744��1447��1448��1449��1450� Nestoros, Susan || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Barr Laboratories, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1850� �1747��1455��1456��1457��1458� Nguyen, Wafa || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">WNguyen@qualitestrx.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">O’Sullivan, Kathleen || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Barr Laboratories, Inc. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1851� �1753��1471��1472��1473��1474� Patel, Shilpa || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Caraco Pharmaceutical Labs, Ltd. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Shilpa.Patel@caraco.com
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Peritore, Sal || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Barr Laboratories, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1852� �1760��1487��1488��1489��1490� Pomraning, Jennifer || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Mylan Labs || <span style="font-size: 11pt; font-family: 'Arial','sans-serif';">Jennifer.Pomraning@mylan.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Roy, Milon || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Unichem || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1853� �1766��1503��1504��1505��1506� Saner, Gary || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Reed Technology || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">GSaner@reedtech.com ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Santoro, Amanda || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Hospira || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv; mso-bidi-font-weight: bold;">Amanda.Santoro@hospira.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Shieh, Betty || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Betty.Shieh@tevausa.com
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Tenaglia, Paul || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Apotex, Inc. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial; mso-bidi-font-size: 10.0pt;">PTenaglia@apotex.com
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Troutman, Craig || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Intagras || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv; mso-bidi-font-size: 9.0pt;">CTrautman@intagras.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial; mso-bidi-font-size: 10.0pt;">Vasquez, Karen || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Roxane Laboratories, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: �1854� �1786��1551��1552��1553��1554� Vu, Ann || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">FDA, Office of Generics Drugs || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Thuyanh.Vu@fda.hhs.gov
 * <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Wells, Hollie || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Hollie.Wells@sandoz.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: 'Tms Rmn';"> <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> ||

<span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> Additions to the meeting: Jeff Poisson – jpoisson@i4i.com Marueen Kapustnski – maureen.kapustnski@cs-americas.com Juris Lazdinis – juris.lazdins@novartis.com Howard Shatz – hshatz@dclab.com Theresa Gerardi – theresa.gerardi@barrlabs.com Nicholas Romano – Nicholas.romano@novartis.com 3 from D& B:  Ryan Paul  PaulR@DNB.com Julie Newman        NewmanJu@DNB.com Tom Marsden   MarsdenT@DNB.com