eCTD v4.0 Perspectives on...
Transcript of eCTD v4.0 Perspectives on...
5/1/2015
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Boris Braylyan
Global Lead,
Information Management – Pfizer Inc.
eCTD v4.0Perspectives on Implementation
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Disclaimers:
This presentation outlines a general technology
direction. Pfizer Inc. has no obligation to pursue any
approaches outlined in this presentation or to develop
or use any functionality mentioned in this
presentation. The technology strategy and possible
future developments are subject to change and may be
changed at any time for any reason without notice.
The views and opinions expressed in this presentation
and any related discussion(s) are solely those of the
individual presenter(s) and may not express the views
of and opinions of Pfizer Inc.
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eCTD v4: Perspectives on Implementation
Benefits
Preparations
Concerns
Challenges and Opportunities
Single Regulatory Standard Across Regions
• Eliminates separate regional
XML, DTD and schemas
• No more updating tools with
new DTDs/schemas for
individual regions
• Majority of updates to
Controlled term lists only
• Plug-and-Play is easier
• Results in Quicker turnaround
from vendors providing updates
• Replaces the need for
regional implementation of
Study Tagging Files (STF)
and Node Extensions
Benefits
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ectd:ectd SYSTEM "util/dtd/ich-ectd-3-
2.dtd">
<?xml-stylesheet type="text/xsl" href="util/style/ectd-2-
0.xsl"?>
<ectd:ectd xmlns:ectd="http://www.ich.org/ectd"
xmlns:xlink="http://www.w3c.org/1999/xlink" dtd-
version="3.2">
<m1-administrative-information-and-prescribing-
information>
<leaf operation="new" xlink:href="m1/us/us-
regional.xml" xlink:type="simple" checksum-type="md5"
checksum="b5ebb584f36ce752a9de2ac710abacba"
ID="us94060">
<title>us-regional</title>
</leaf>
</m1-administrative-information-and-prescribing-
information>
<m2-common-technical-document-summaries>
<m2-2-introduction>
<leaf operation="new" xlink:href="m2/22-
intro/introduction.pdf" xlink:type="simple" checksum-
type="md5" ID="94060-1697253" application-
version="PDF 1.4"
checksum="f8c246f02d6fe20a810b2b3288e68a80">
<title>CTD Introduction</title>
</leaf>
</m2-2-introduction>
<m2-3-quality-overall-summary>
<m2-3-introduction>
<leaf operation="new" xlink:href="
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Structure and Re-use
• Structure is independent of application format
• There is no Table of Contents stored within Regulated
Product Submission (RPS) standard
• Changes to the ICH and regional structure no longer required
in schema – Just a change to the Controlled Vocabulary
Terms
• Enables Re-Use
• Unique identifier approach means documents can be
referenced/reused more effectively
– Across a Submission Unit (Sequence)
– Across an application
– Across different applications
Benefits
More Stable and Versatile
• Removes ‘Append’ operation that caused lifecycle
issues in the past
• v4.0 enables metadata corrections
• Section attribute information in eCTD v3.2.2 cannot be
updated
– Currently required to create new section, delete
documents and then add them back as new in the new
section
Benefits
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EU Grouping / Worksharing
In v3.2.2 individual
eCTD sequences
had to be created
for each product in
the grouping/
workshare
v4.0 will enable a
single eCTD to be
created and
reference
appropriate
documents
Benefits
Potential for Two-Way Communication
Receive questions and other communications
back from the Health Authority as eCTD v4.0
Ability to keep track of status of the application
through metadata provided back by the Health
Authority
Implementation across regions may be limited
• Further discussion required in the EU
Benefits
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Flattened, Flexible Folder Structure
Benefits
E
T
C
Benefits
Significantly
reduces issues
with long file
paths
Flexibility of
folder structure
Getting Ready for eCTD v4Always be prepared
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Some Assembly Required
Machine friendly - Human unfriendly• Designed and structured for systems to read
• Tools required to create/manage and view eCTD v4.0
• Difficult to make manual corrections/fixes
• With eCTD v3.2.2 it was easy to manually create a pilot submission
• eCTD v4.0 submissions much more complex to create without tools
Prepare
Tool Implementation
eCTD v4.0 requirement for tools raises questions about vendor models:
• Maintenance release?
• Lower impact to business, but vendors not covering their costs
• New module?
• Vendors will charge
• New tool?
• Vendors will charge
• Additional impact to applicants for training users and adapting processes to new solution
separate from eCTD v3.2.2 publishing solution
• When will vendors be ready?
• Need build, view and review solutions in place at applicants and health authorities respectively
before eCTD v4.0 can be truly implemented
• Do costs to applicants and health authorities outweigh the benefits?
Prepare
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Transitioning from v3.2.2
• Not a ‘baseline’, but a way to continue the lifecycle
• Current eCTD view will be transitioned, but not anything pre-
eCTD
• How to transition?
– Tools will be needed
– Conversion/Transition won’t be reviewed by Health
Authorities
– Structure ONLY: Applicant can’t fix or modify content
Prepare
eCTD v4 – Challenges and Concerns
Anything worth doing is worth doing right…
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4.3
2.5
3.5
4.5
2.4
4.4
1.8
2.8
2 2
3
5
0
1
2
3
4
5
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Category 1Category 2Category 3Category 4
Series 1 Series 2 Series 3
Continuous Improvement
The specification/implementation must continue to
improve to achieve the full benefits promised when
we started on the RPS journey
– 2-way communication
– Maximize component reuse model
Concerns
• Regions are still not completely aligned: eCTDv4.0 being implemented differently per region
Single standard, but slight differences in the way it will
be implemented
Have not achieved a “single global submission”;
Applicants will still have to create regional versions
Change Control
Any regional updates requiring model/schema changes will need to go through International Conference on Harmonisation (ICH) and HL7• Cannot just implement regionally (unless it does not
impact the model/schema)
• More cumbersome and will take longer to make and implement changes (but we do have a single standard and these changes should be much less frequent)
Concerns
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Reliance on Tools
Will vendors be ready?
• Are drivers and profits significant enough to fuel rapid
R&D?
Manual fixes very difficult in v4
• Previously possible work-arounds won’t be so easy
with v4.0
Concerns
Timing is Everything
When to make the move to v4.0?
Concerns
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Case for Consideration: Phased Implementation
1. A product may be moved to eCTD v4.0 in one region
2. Still need to produce v3.2.2 for other regions not accepting v4.0 yet
3. Continued need for non-eCTD electronic submissions/paper for international marketsa) Will we be able to clone/reuse v4.0 components for
v3.2.2 & Non-eCTD electronic Submissions (NeeS)?
b) A non harmonised implementation phase will mean excessive costs for Applicants; Need to drive for alignment as quickly as possible
Concerns
Case for Consideration: Health Authority Unknowns
1. When will other eCTD markets move to eCTD
v4.0?
a) e.g. Australia, Canada, South Africa, Saudi Arabia,
Oman, Thailand…
2. Will other markets directly implement eCTD
v4.0 or introduce v3.2.2 as a stepping stone?
3. Aligned adoption and implementation of v4.0
would significantly lower costs through
maximisation of reuse
Concerns
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The Missing Links
Global companies must ensure the flatter folder structure:
Is the same across eCTD regions
Adheres to all regions to avoid reworking of inter-document hypertext links• Tools may assist: If the links are created/stored in the
build solution
• New standard, different structure: eCTD v4.0 will require reworking links to meet v3.2.2 standards for other regions
Concerns
Getting Up to Speed
User training and acclimatisation
likely to be complex
• More metadata than v3.2.2
• Expect training issues initially – will take
time to develop internal organisational
courses and resources
• Confusion likely from lack of understanding of
differences between eCTD v3.2.2 and v4.0
(particularly if using both standards concurrently)
• High-level business processes should not be affected,
but expect significant operational changes
Concerns
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Challenges and Opportunities
Expect additional problems to arise as we gain
experience working with v4.0
Expect teething problems with any big change
to a standard
Ask