QeL

 
Developing Clinical Highlights Data Elements for SPL
An in-depth, hands-on workshop
Instructors: Leander Fontaine, M.D.,  Sidney Kahn, M.D.
April 2 & 3 , 2007 | Sheraton Hotel, King of Prussia, PA
 

Agenda


Monday, April 2, 2007

8:30 A.M -
12:30 P.M
Instructors Welcome, Introduction of Participants
  
Theory
  
The process of developing computer processable Highlights - Overview
Regulatory strategy and other considerations
Walk through the set of elements available to capture concepts
Assembling groups of elements to form a label-specific HLDE structure
Coding
12:30 P.M
  
Lunch break
1:15 P.M -
5:00 P.M
Introduction to practice forms, terminologies and browsers
 
Analyzing Highlights text in the light of available data elements and SPL structuring rules
Deciding what can and cannot be captured using available data elements
Creating a structured representation of highlights text as a prerequisite for worksheet element assembly
Verifying the codability of selected terms to confirm that the selected information structure can be realized
 
Creating the data element structure
 
Assembly of a customized spreadsheet to match the structured representation of Highlights content
Includes step-by-step analysis and discussion of FDA's guidance documents
Defining what can and what can not be captured based on the elements of the information model currently enabled by FDA's Implementation Guide
5:00 P.M
  
End Of Day 1

Tuesday, April 3, 2007

8:30 A.M -
12:30 P.M
Term Selection to represent Highlights concepts
 
Part 1: VA/KP Problem List subset and SNOMED CT
Practical coding using the YATBU and Clue browsers
Experiencing typical challenges in finding dictionary terms – Search strategies
Discussion of options where appropriate dictionary terms are not available
 
 
Part 2: LOINC and other code systems
Practical coding using code tables
Experiencing typical challenges in finding terms - Search strategies
Discussion of options where appropriate dictionary terms are not available
12:30 P.M
  
Lunch
1:30 P.M -
4:00 P.M
Section-specific XML code
  
Understanding the logic of the XML Highlights element groups for the individual sections and subsections of the Full Prescribing Information text
Review of the Clinical Information Model's syntax rules
 
 
Interpreting the HLDE table rendered by FDA's standard stylesheet
 
Understanding the difference between data input format and data output format
Pros and cons of using the stylesheet's HLDE table format as a HLDE worksheet
Tracing HLDE table content back to Highlights text
Using the stylesheet's HLDE table and the HLDE worksheets as quality control tools and during labeling negotiations
 
Lessons learned and general Q&A
4.00 P.M
  
End of Workshop

 

Register early! Space is limited!

 

Participants are encouraged to bring personal laptop computers which will enable them to perform all exercises in parallel with the demonstration by the instructors.

 

It is not necessary to bring a laptop to get the full course benefit.

 

As this workshop is highly interactive, the length and timing of each module is an estimate and the sequence of the modules may be changed to match the needs of the attendees. However, all topics in the agenda will be covered.

 

Participants are invited to submit special Highlights text scenarios for inclusion in the Mock Highlights section used for the workshop exercises, and to submit questions and topics of special interest to
training@qelabeling.com

How to register:

Click Here For: Registration Form & Pricing

By phone: Please call Quadrant eLabeling Services LLC (QeL) at: +1 (610) 353-4424

By fax:     Fax the completed registration form to QeL: +1 (610) 903-4411

By mail:    Mail the completed registration form (with check, if applicable) to
                  Quadrant eLabeling Services LLC
                  355 Lancaster Avenue, Building E, Haverford PA 19041, USA.

Venue Information:




Sheraton Hotel
King of Prussia, PA.
(610)-878-1460 - Ask for Karen Vincent

 

For hotel reservations, please contact the hotel directly. Special room rates for Quadrant eLabeling Services Workshop offered.

Click for Directions

 
 
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