Sr. Manager, Information Solutions - Life Sciences
Transforming Data, Delivering Information™
7 Walnut Grove Drive - Horsham, PA 19044
Office: +1-215-441-6454 -Mobile: +1-610-731-7192 - Fax: +1-215-441-6342
www.ReedTech.com - gsaner@ReedTech.com
Connection information for today�s SPL Tech Team Meeting is below.
Date: Monday, Aug 26, 2013
Time: 2:00 � 3:00 PM EDT
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For those who do not have access to WebEx, attached are the sides for today’s meeting.
Myron
Please “Reply” to indicate your attendance in today’s meeting.
Gary Saner,
Sr. Manager, Information Solutions - Life Sciences
Reed Technology and Information Services Inc.
Transforming Data, Delivering Information™
7 Walnut Grove Drive - Horsham, PA 19044
Office: +1-215-441-6454 -Mobile: +1-610-731-7192 - Fax: +1-215-441-6342
www.ReedTech.com -
gsaner@ReedTech.com
From: Finseth, Myron [mailto:myron.finseth@medtronic.com]
Sent: Monday, August 26, 2013 1:20 PM
To: 'aagurto@intagras.com'; 'IBaig@virtify.com'; 'tbelch@ptc.com'; 'paule.belony@thebelony.com'; 'joan.berger@imagesolutions.com'; 'rbrandt@quark.com'; 'jbruner@i4i.com'; 'theresa.m.brunone@gsk.com'; 'teresa.cappetta@abbott.com'; 'antonio.r.cassata@pfizer.com';
'chris.cinege@pfizer.com'; 'COWALL-HANOVER_PATRICIA_L@LILLY.COM'; 'wcypers@arisglobal.com'; 'PDesai@virtify.com'; 'Girish.dhavaleswar@hospira.com'; Elkin, Jackie; 'Tammy.Feichtel@glemser.com'; 'Mark.Filipps@glemser.com'; 'fontaine@pharmiceutics.com'; 'dfriedman@virtify.com';
'William.Friggle@sanofi-aventis.com'; 'steven.gitterman@fda.hhs.gov'; 'ed.gormsen@thinspring.com'; 'Zachary.Gray@hospira.com'; 'Pawel.Halaczkiewicz@hospira.com'; 'thardin.us@gmail.com'; 'marc.hart@pharma.com'; 'mharvey@qualitestrx.com'; 'HILL_NATHANIEL_H@LILLY.COM';
'catherine.hoang2@va.gov'; 'KHoard@eesus.jnj.com'; 'katherine.hollinger@fda.hhs.gov'; 'jagruthi.kasuganti@takesolutions.com'; 'rmk@pharma-com.us'; 'kolac@mail.nlm.nih.gov'; 'alan.krueger@abbott.com'; 'SKuhn@PRDUS.JNJ.COM'; 'BLanglois@primusrx.com'; 'kutu@kubstech.com';
'glecain@intagras.com'; 'Kathleen.Lins@hospira.com'; 'Jlorenc@reedtech.com'; 'douglas.luczak@abbott.com'; 'amartino@octagonresearch.com'; 'anie.mathews@fda.hhs.gov'; 'cmathis@lorenz.cc'; 'miller.fred@gene.com'; 'Behnaz.Minaei@fda.hhs.gov'; 'jacquelyn.mohns@bms.com';
'Erika.Morgan@hospira.com'; 'wnguyen@qualitestrx.com'; 'Dragan.Obradovich@abbott.com'; 'Denise.Oliveira@genzyme.com'; 'Drew.Palsgrove@pfizer.com'; 'ragunathan.pathmanathan@abbott.com'; 'BPedrow@gs1us.org'; 'pamela.peris@abbott.com'; 'arago@intagras.com'; 'grao@quantument.com';
'Terrie.Reed@fda.hhs.gov'; 'eva.rivera@glemser.com'; 'mikhail.rodnyanskiy@bms.com'; 'gsaner@reedtech.com'; 'gunther@pragmaticdata.com'; 'JSecunda@AdvaMed.org'; 'jSeideman@dclab.com'; 'hshatz@dclab.com'; 'sudheer_sindia@merck.com'; 'ioana.singureanu@va.gov';
'solosack@yahoo.com'; 'amy_soslow@merck.com'; 'SSpiewak@reedtech.com'; 'greg.staudenmaier@va.gov'; 'jstovall@amgen.com'; 'brian.suggs@watson.com'; 'binh.ta@fda.hhs.gov'; 'kthomas@i4i.com'; 'jtodes@qelabeling.com'; 'Leslie.Tompkins@fda.hhs.gov'; 'ctrautman@intagras.com';
'edward.tripp@estripp.com'; 'Sheila.Vogdes@abbott.com'; 'rich.ware@astrazeneca.com'; 'jennifer.west@abbott.com'; 'Cham.Williams@tevapharm.com'; 'cwilson@intagras.com'; 'mary_beth_wilusz@merck.com'; 'rcrimspl@lists.hl7.org' (rcrimspl@lists.hl7.org); Levin,
Randy (CDER) (randy.levin@fda.hhs.gov); Gunther Schadow (gunther@pragmaticdata.com); lonnie.smith (lonnie.smith@fda.hhs.gov); 'Cappetta, Teresa A'; 'Bojahr, Oliver'; 'Hernandez, Joyce'; 'Alcini Paolo'; Spiewak, Sandra (RTIS); 'Kiser, John W'; 'Anderson, Craig';
'Gentry, Janet'; 'Schwickrath, Anthony'; 'Andy Martin'; 'Peris, Pamela J'; 'Mathews, Anie'; 'Lins, Kathleen'; 'Kutumba Lanka'; 'Scott Moss'; 'Michael Sauter'; 'Craig Trautman'; 'Terry Brunone'; 'Poteat, Andrea C'; 'Wilusz, Mary Beth'; 'Paula Markert'; 'Faunce,
Frank'; 'Frederic Miller'; 'Vogdes, Sheila A'; 'Stovall, Jeff'; 'Hoang, Catherine'; 'Stephen.Miko@Merial.com'; 'Patricia L Cowall-Hanover'; Saner, Gary (RTIS); 'Secunda, Jeffrey'; 'Alex Agurto'; 'Hilary Hafeken'; 'Perucci, Philip'; 'Pan, Elaine'; 'Buxton Tim';
'alexandra.hughes@hc-sc.gc.ca'; 'Julie James'; 'Lisa K Grim'; 'Feichtel, Tammy'; 'Nguyen, Wafa'; McVay, Jeffrey; Dittmann, Kristin; Dauplaise, Michael; Singh, Manish; Arshad, Mohammad; Kastury, Krishna; Gettelman, Gina; 'Calia, Rob'; Pierson, Brent; Boos,
Tim; Walton, Toni; 'Obradovich, Dragan'; 'slmyszka@mmm.com'; 'Richard Brandt'; cecil.o.lynch@accenture.com
Subject: Slides for today's meeting
For those who do not have access to WebEx, attached are the sides for today’s meeting.
Myron
Myron Finseth
SPL Tech Team Co-Chair
FYI
Agenda for today’s meeting
1. Approve meeting minutes from Aug 26, 2013 meeting.
2. HL7 SPL R5 standard status (vote to approve the advancement to Normative) (see details below).
3. Should SPL Tech Team follow and discuss related HL7 standards (ITS datatypes, other RCRIM standards, etc.)?
4.
FDA Webinar: SPL Document Authoring Software Vendor Training Session
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm366198.htm
Originally scheduled for September 23, 2013 9:00 AM-12:30 PM; now postponed until Monday, December 16, 2013
If you have already registered for this event, you do not need to re-register.
5.
NLM Free Public Meeting: SPL/DailyMed Jamboree Workshop – Using DailyMed Drug Product Label Data
http://www.nlm.nih.gov/mesh/spl_workshop.html
Date/Time: October 28, 2013, 9:30 AM to 3:30 PM, Registration is required, seating is limited
SPL R5 Proposal:
The SPL Technical Team should recommend to HL7 “Regulated Clinical Research Information Management” (RCRIM) that the SPL R5 standard should be taken from “Draft Standard for Trial Use” (DSTU) to “Normative.”
Vote: Yes - I agree, OR No - I disagree
Voting Notes:
· All votes will be confidential
· One vote per SPL Technical Team member (one does not need to be an HL7 member to vote)
· Voting time period will be open for 1 week, close Sep 16, 11:59 PM.
· Send responses to Gary Saner, gsaner@reedtech.com
Gary Saner,
Sr. Manager, Information Solutions - Life Sciences
Reed Technology and Information Services Inc.
Transforming Data, Delivering Information™
7 Walnut Grove Drive - Horsham, PA 19044
Office: +1-215-441-6454 -Mobile: +1-610-731-7192 - Fax: +1-215-441-6342
www.ReedTech.com -
gsaner@ReedTech.com
From: Finseth, Myron [mailto:myron.finseth@medtronic.com]
Sent: Monday, September 09, 2013 9:34 AM
To: 'aagurto@intagras.com'; 'IBaig@virtify.com'; 'tbelch@ptc.com'; 'paule.belony@thebelony.com'; 'joan.berger@imagesolutions.com'; 'rbrandt@quark.com'; 'jbruner@i4i.com'; 'theresa.m.brunone@gsk.com'; 'teresa.cappetta@abbott.com'; 'antonio.r.cassata@pfizer.com';
'chris.cinege@pfizer.com'; 'COWALL-HANOVER_PATRICIA_L@LILLY.COM'; 'wcypers@arisglobal.com'; 'PDesai@virtify.com'; 'Girish.dhavaleswar@hospira.com'; Elkin, Jackie; 'Tammy.Feichtel@glemser.com'; 'Mark.Filipps@glemser.com'; 'fontaine@pharmiceutics.com'; 'dfriedman@virtify.com';
'William.Friggle@sanofi-aventis.com'; 'steven.gitterman@fda.hhs.gov'; 'ed.gormsen@thinspring.com'; 'Zachary.Gray@hospira.com'; 'Pawel.Halaczkiewicz@hospira.com'; 'thardin.us@gmail.com'; 'marc.hart@pharma.com'; 'mharvey@qualitestrx.com'; 'HILL_NATHANIEL_H@LILLY.COM';
'catherine.hoang2@va.gov'; 'KHoard@eesus.jnj.com'; 'katherine.hollinger@fda.hhs.gov'; 'jagruthi.kasuganti@takesolutions.com'; 'rmk@pharma-com.us'; 'kolac@mail.nlm.nih.gov'; 'alan.krueger@abbott.com'; 'SKuhn@PRDUS.JNJ.COM'; 'BLanglois@primusrx.com'; 'kutu@kubstech.com';
'glecain@intagras.com'; 'Kathleen.Lins@hospira.com'; 'Jlorenc@reedtech.com'; 'douglas.luczak@abbott.com'; 'amartino@octagonresearch.com'; 'anie.mathews@fda.hhs.gov'; 'cmathis@lorenz.cc'; 'miller.fred@gene.com'; 'Behnaz.Minaei@fda.hhs.gov'; 'jacquelyn.mohns@bms.com';
'Erika.Morgan@hospira.com'; 'wnguyen@qualitestrx.com'; 'Dragan.Obradovich@abbott.com'; 'Denise.Oliveira@genzyme.com'; 'Drew.Palsgrove@pfizer.com'; 'ragunathan.pathmanathan@abbott.com'; 'BPedrow@gs1us.org'; 'pamela.peris@abbott.com'; 'arago@intagras.com'; 'grao@quantument.com';
'Terrie.Reed@fda.hhs.gov'; 'eva.rivera@glemser.com'; 'mikhail.rodnyanskiy@bms.com'; 'gsaner@reedtech.com'; 'gunther@pragmaticdata.com'; 'JSecunda@AdvaMed.org'; 'jSeideman@dclab.com'; 'hshatz@dclab.com'; 'sudheer_sindia@merck.com'; 'ioana.singureanu@va.gov';
'solosack@yahoo.com'; 'amy_soslow@merck.com'; 'SSpiewak@reedtech.com'; 'jstovall@amgen.com'; 'brian.suggs@watson.com'; 'binh.ta@fda.hhs.gov'; 'kthomas@i4i.com'; 'jtodes@qelabeling.com'; 'Leslie.Tompkins@fda.hhs.gov'; 'ctrautman@intagras.com'; 'edward.tripp@estripp.com';
'Sheila.Vogdes@abbott.com'; 'rich.ware@astrazeneca.com'; 'jennifer.west@abbott.com'; 'Cham.Williams@tevapharm.com'; 'cwilson@intagras.com'; 'mary_beth_wilusz@merck.com'; 'rcrimspl@lists.hl7.org' (rcrimspl@lists.hl7.org); Levin, Randy (CDER) (randy.levin@fda.hhs.gov);
Gunther Schadow (gunther@pragmaticdata.com); lonnie.smith (lonnie.smith@fda.hhs.gov); 'Cappetta, Teresa A'; 'Bojahr, Oliver'; 'Hernandez, Joyce'; 'Alcini Paolo'; Spiewak, Sandra (RTIS); 'Kiser, John W'; 'Anderson, Craig'; 'Gentry, Janet'; 'Schwickrath, Anthony';
'Andy Martin'; 'Peris, Pamela J'; 'Mathews, Anie'; 'Lins, Kathleen'; 'Kutumba Lanka'; 'Scott Moss'; 'Michael Sauter'; 'Craig Trautman'; 'Terry Brunone'; 'Poteat, Andrea C'; 'Wilusz, Mary Beth'; 'Paula Markert'; 'Faunce, Frank'; 'Frederic Miller'; 'Vogdes,
Sheila A'; 'Stovall, Jeff'; 'Hoang, Catherine'; 'Stephen.Miko@Merial.com'; 'Patricia L Cowall-Hanover'; Saner, Gary (RTIS); 'Secunda, Jeffrey'; 'Alex Agurto'; 'Hilary Hafeken'; 'Perucci, Philip'; 'Pan, Elaine'; 'Buxton Tim'; Gettelman, Gina; McVay, Jeffrey;
Dittmann, Kristin; Dauplaise, Michael; Singh, Manish; Pierson, Brent; Arshad, Mohammad; Boos, Tim; Kastury, Krishna; Walton, Toni; 'slmyszka@mmm.com'; 'Alan Kreikemeier'; 'Brosch Sabine'; 'Nguyen, Wafa'
Cc: 'rcrimspl@lists.hl7.org' (rcrimspl@lists.hl7.org)
Subject: Meeting minutes attached (from 8/26/2013)
Myron Finseth
SPL Tech Team Co-Chair
All,
Please Reply (Not Reply All) to indicate you attendance in the meeting today.
Thank you,
Gary
Gary Saner,
Sr. Manager, Information Solutions - Life Sciences
Reed Technology and Information Services Inc.
Transforming Data, Delivering Information™
7 Walnut Grove Drive - Horsham, PA 19044
Office: +1-215-441-6454 -Mobile: +1-610-731-7192 - Fax: +1-215-441-6342
www.ReedTech.com -
gsaner@ReedTech.com
All,
This email is sent to record your vote for the following SPL Technical Team proposal.
SPL R5 Proposal:
The SPL Technical Team should recommend to HL7 “Regulated Clinical Research Information Management” (RCRIM) that the SPL R5 standard should be taken from “Draft Standard for Trial Use” (DSTU) to “Normative.”
Vote:
Yes - I agree, OR No - I disagree
Send “REPLY” response to Gary Saner, gsaner@reedtech.com
Voting Notes:
· All votes will be confidential
· One vote per SPL Technical Team member (one does not need to be an HL7 member to vote)
· Voting time period will be open for 1 week, close Sep 16, 11:59 PM.
Thanks for your vote on this topic!
Gary
Gary Saner,
Sr. Manager, Information Solutions - Life Sciences
Reed Technology and Information Services Inc.
Transforming Data, Delivering Information™
7 Walnut Grove Drive - Horsham, PA 19044
Office: +1-215-441-6454 -Mobile: +1-610-731-7192 - Fax: +1-215-441-6342
www.ReedTech.com -
gsaner@ReedTech.com
All,
If you haven’t voted on the SPL R5 proposal, please do so NOW. Voting will be closed at 11:59 pm TONIGHT.
Thanks,
Gary
Gary Saner,
Sr. Manager, Information Solutions - Life Sciences
Reed Technology and Information Services Inc.
Transforming Data, Delivering Information™
7 Walnut Grove Drive - Horsham, PA 19044
Office: +1-215-441-6454 -Mobile: +1-610-731-7192 - Fax: +1-215-441-6342
www.ReedTech.com -
gsaner@ReedTech.com
From: Saner, Gary (RTIS)
Sent: Monday, September 09, 2013 4:34 PM
Subject: SPL Tech Team - SPL R5 Vote
All,
This email is sent to record your vote for the following SPL Technical Team proposal.
SPL R5 Proposal:
The SPL Technical Team should recommend to HL7 “Regulated Clinical Research Information Management” (RCRIM) that the SPL R5 standard should be taken from “Draft Standard for Trial Use” (DSTU) to “Normative.”
Vote:
Yes - I agree, OR No - I disagree
Send “REPLY” response to Gary Saner, gsaner@reedtech.com
Voting Notes:
· All votes will be confidential
· One vote per SPL Technical Team member (one does not need to be an HL7 member to vote)
· Voting time period will be open for 1 week, close Sep 16, 11:59 PM.
Thanks for your vote on this topic!
Gary
Gary Saner,
Sr. Manager, Information Solutions - Life Sciences
Reed Technology and Information Services Inc.
Transforming Data, Delivering Information™
7 Walnut Grove Drive - Horsham, PA 19044
Office: +1-215-441-6454 -Mobile: +1-610-731-7192 - Fax: +1-215-441-6342
www.ReedTech.com -
gsaner@ReedTech.com