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Subject: RE: Your presentation of OASIS eTMF Standard at DIA global conference


Hi Zack,

 

There will be only one official session at the DIA 2015 annual meeting regarding the TMF Reference Model and OASIS eTMF Standard.

The title of the session is “Advances in TMF Standards by Harmonizing Clinical and Technical Strengths”

 

The session is chaired by Donna Dorozinsky (DWD Associates)

 

Speakers:

Eric Rubinson at Actavis – TMF Reference Model

Michael Agard, Paragon Solutions, Inc. OASIS eTMF Standard

 

·         (Michael) Interoperability: Think Standard Inventory Means Technical Interoperability? Think Again.” – Empower the navigation and exchange of TMF components with technical interoperability standards.

·         (Eric) Content Structure: Just the ‘facts…” – Ensure the completeness and equivalence of TMFs by mapping record inventory to standard, industry-embraced content artifacts.

·         (Donna) The synergy of the two: “Achieve Synergy between Clinical and Technical TMF standard with these simple steps.”

 

The goal of the session is to focus on synergy between the TMF Reference Model and OASIS eTMF Standard.  We need the contribution of both clinical and technical personnel to advance the standard.  We need to work together, rather than re-inventing the wheel.  Siloed approaches will not further standardization and interoperability.  We want to emphasize the business needs and value of both streams of work. The goal is to get more contributions and adoption.  All of the speakers agree that we want to be viewed as credible, neutral, and without political/business agendas behind the presentation.

 

My slides and notes are still in progress and will be provided as soon as possible.

 

 

Michael Agard | Principal Consultant | Paragon Solutions | www.consultparagon.com

email:  magard@consultparagon.com  phone:  610.832.8110 | fax:  610.832.8115 | cell:  484.889.7136

 

 

** Confidential **

 

From: Zack Schmidt [mailto:zs@sureclinical.net]
Sent: Saturday, April 25, 2015 10:55 PM
To: Agard, Michael
Cc: Carol Geyer; Scott McGrath; etmf@lists.oasis-open.org
Subject: Your presentation of OASIS eTMF Standard at DIA global conference

 

Hi Michael, 

 

Based on our TC meetings, its my understanding that you'll be promoting the OASIS eTMF Standard TC at the DIA global conference in June 2015.  

 

 I'd like to ask that you share your planned outline for your presentation at DIA and any speaker notes with the TC so that you have the most accurate information for the presentation.

 

Also, since you are involved with the TMF RM group, can you please share with the TC an outline of what any DIA forums or seminars at the DIA global conference with respect to the OASIS eTMF Standard TC and the DIA TMF Ref Model.

 

Best,

Zack

 


 

--

Zack Schmidt, CEO
SureClinical 

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Rancho Cordova, CA  95742

Support: 916-265-2000

Direct:  916-265-2004

 

 

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