Transcript PRESENTATION TITLE IS ARIAL BOLD, CAPS, 30 PT

RPS Status
Update
Joel Finkle
Senior Strategist
Regulatory Informatics
CSC Regulatory
Solutions Group
March 2011
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Status Update
I.
RPS Project History
3
II.
RPS Model Overview
13
III.
Ballot and Implementation Plan
35
RPS History
Origins of RPS
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Two major goals
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Provide for the Next Major Version to the ICH eCTD standard
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ICH eCTD 4.0 will be based on RPS
Support changes in granularity
Support changes to metadata
Better support for Master Files
Better support for bundled supplements
Support for two-way communication
Provide a standard that the US FDA can implement across all
centers
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Centers other than Drugs and Biologics need different document types
ICH eCTD has hard element names that map to TOC sections
Two-way communication
Lower support and training costs by having only one review system
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Release 1
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Created for FDA Requirements
Known that it would not meet all needs
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Did not include all ICH requirements
Rapid schedule to permit FDA implementation
Approved as an HL7 ANSI Standard March
2008
Has not been implemented
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Release 2
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Additional Requirements Incorporated
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Two-way communication requirements for FDA were included
Contact Parties: Senders and Receivers
Related Context of Use for revisions, related documents
Additional information for Devices (CPM CMET)
EU Requirements begin to be incorporated
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Approval information (especially useful for EMA with multiple regulators)
Documents can be tagged for particular review agencies
(e.g. labeling)
Approved as Draft Standard for Trial Use in 2010
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DSTU had large participation
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Significant testing done
Vendor prototype tools were available
As it went to ballot, additional requirements from EU and Japan appeared
Will not be balloted as a Normative Standard
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Release 2 Version 2
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Formerly called Release 3
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R2 did not go to normative ballot
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PROJECT NAME: RPSr3
BALLOT NAME: RPSr2 D2 (DSTU 2)
EXPECTED STANDARD NAME: RPSr2
Additional ICH, regional EU and Japan requirements
Major changes to structure
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“Document” concept
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Support for multiple files as a single document
All “Study Tagging Files” features and then some
Submission Groups
Thorough examination of content life cycle
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Model Overview
Content Warning
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The following slide presents frightening, complex
structures
The ones after that provide overviews of the 6 major “acts”
in the standard
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Submission Unit
Submission
Application
Document
Context of Use
Review
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Overview
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS: Submission Unit
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Root of the message
A package of information:
equivalent to ICH Sequence
Provides further categorization
of submission sequences
Identifies sender and receiver
Identifies which Submissions
the sequence pertains to (see
next page) and assigns a
Sequence Number within the
Submission
Carries all the Contexts of Use
(described later)
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS: Submission
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A series of submission units in support
of a regulatory activity
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May be subsetted by Reviewable Units
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US FDA CDRH Requirement
May be used by other authorities
Each belongs to one Application
(see next page)
May have multiple Review activities
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Initial Application
Supplement or Variation
Annual Report
Supports EU need for one regulatory
activity to be approved by many
agencies (described later)
Has Mode (submission type for EU)
May be grouped into SubmissionGroup
May have contact information`
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS: Application
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Provides organization for the
regulated product class
Defines the dossier type
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Has Procedure (EU only)
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Used in Master Files
Owns the Keywords
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Centralised, National, Mutual
Recognition or Decentralised.
Identifies countries
References other applications
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e.g. NDA, 510K, MAA, etc.
Metadata
STF-like identifiers
Owns the Documents (next page)
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS: Document
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Either a physical file, or set of IDs of other documents
Permits hierarchically structured documents
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Previously handled by STFs, but this can also roll up granularity
Documents have codes and keywords like Context of Use (see next page)
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Used like STF tags and metadata
Does not specify place in submission – that’s for the Context of Use
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS: Context of Use
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Similar to eCTD Leaf
Has codes to identify
location in dossier
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Flexible for any
submission type
Presentation order
determined by
submission structure,
“Priority” in connection to
Submission Unit
Points to Document
Points to Keywords
May be limited to particular
Submissions (workshare)
…or Agencies (e.g.
labeling for different EU
countries)
May be linked or related to
other ContextOfUse items
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS: Review
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Review information is used primarily by EU, where the review status
may differ for each authority and it is important to keep track of what
doses, etc. are approved in each region
Still needed: a status code other than the HL7 status
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Ballot and Implementation Plan
When will we get there?
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Ballot for Draft Standard in September 2011
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Vendors, agencies and sponsors being solicited for testing
Likely earliest approval is September 2012
Likely earliest FDA adoption is late 2013
EU/Japan will not implement until approved as an ISO
standard
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Not determined yet whether this will be a JIC
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Preparation for Ballot
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Model
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Model Walkthrough
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Completed
Schema
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In draft, trying to reconcile between plain english and HL7-ese
Storyboards
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In review, in good shape
Glossary
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One possible item to add (submission status using regulator terms)
Definitions to be copied from Glossary
Waiting for finalization of Model
Tutorial Information
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Above and beyond ballot requirements
Significant effort toward Implementation Guide
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Challenges
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Adoption
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EMA and Japan will not accept until it is an ISO standard
FDA will not implement before late 2012 at the earliest
Because there is an existing standard for Drugs and Biologics (eCTD), requirement
to use RPS will be phased in
Controlled Vocabularies
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Many controlled lists are needed
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Context of Use is the biggest one – need both eCTD and other submission types
Many of the Keywords will need vocabularies (some already exist)
Submission Types, Application Types, Document Types
Regulatory Statuses
Relationships between controlled lists and review systems has not been
worked out, for example:
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For Safety reports, a keyword such as Species is of lower precedence than the
Context of Use
For Quality, a keyword such as Drug Substance is of higher precedence than many
levels of Context of Use
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
RPS Status Update
THANK YOU
© 2011 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.