2. Disclaimer
The views and opinions expressed in the following PowerPoint slides are
those of the individual presenter and should not be attributed to Drug
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employed or affiliated.
These PowerPoint slides are the intellectual property of the individual
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3. Agenda
1. Introduction Overview
2. The eCTD Standard Release Strategy
3. Stable Software vs. Up-to-date Software Releases
4. Insight into the techniques
5. What Can a Sponsor Do?
6. Conclusion
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4. Agenda
1. Introduction Overview
2. The eCTD Standard Release Strategy
3. Stable Software vs. Up-to-date Software Releases
4. Insight into the techniques
5. What Can a Sponsor Do?
6. Conclusion
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5. 1. Introduction and Overview
• In November 2000 the M4 working group of the ICH
reached an agreement on the international standard
Common Technical Document (CTD) for presenting
structured submissions at the regulatory authorities
within the three ICH-Regions (Europe, USA and Japan).
• In the EU:
– From 1st January 2010 the eCTD is the only electronic format
that can be used in the Centralised Procedure.
– A significant majority of Member States is in a position to receive
electronic-only submissions
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6. 1. Introduction and Overview
Advantages of eCTD Disadvantages of eCTD
Organization of documents Expensive software solutions
Organization and presentation of Alternative solution:
metadata of separate files Time-consuming manual work
MD5 checksum Changes of internal processes
Possibility to create country-specific …
versions
Document lifecycle can be maintained
and various views are made possible
XML linking functionality
Copy Paste functionality
Usage of 21 CFR part 11 compliant
electronic signatures
…
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7. Agenda
1. Introduction Overview
2. The eCTD Standard Release Strategy
3. Stable Software vs. Up-to-date Software Releases
4. Insight into the techniques
5. What Can a Sponsor Do?
6. Conclusion
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8. 2. The eCTD Standard Release Strategy
There are 2 different release types
Major Releases Minor Releases
Will be announced at least two years before The scope of these minor releases will be to
they occur correct minor issues with the specifications
that hinder standards implementation or
software application development
Include changes that significantly impact Notification will occur when the minor release
DTDs, major modifications to architecture, or is published on the Notice to Applicant
significantly impact the software applications
being used
Will be addressed by the Joint TIGes- Modifications introduced in the European
Industry eCTD Implementation Group and eCTD Standards to comply with CTD
follow the Change Control Process guidance will be considered minor releases
and proposed by the NtA-TIGes Interlinking
Group
Will be identified by a new numbering Will continue the numbering sequence of the
sequence (e.g., 2.0, 3.0) last major release (e.g., 2.1, 2.3)
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9. Agenda
1. Introduction Overview
2. The eCTD Standard Release Strategy
3. Stable Software vs. Up-to-date Software Releases
4. Insight into the techniques
5. What Can a Sponsor Do?
6. Conclusion
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10. 3. Stable Software vs. Up-to-date
Software Releases
The Product Release Cycle
2011 2012
Release 2.1 Release 2.2 Release 2.3 Release 3.0
Maintenance V2.1 Maintenance V2.2 Maintenance V2.2
Development V2.2 Development V2.3 Development V2.3
The Product Release Cycle - Reality
2011 2012
Release 2.1 Release 2.2 Release 2.3 Release 3.0
Maintenance V2.1 Maintenance V2.2 Maintenance V2.2
Development V2.2 Development V2.3 Development V2.3
! Not all customers are up-to-date with the production software version
Maintenance of many older production versions are necessary
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12. 3. Stable Software vs. Up-to-date
Software Releases
The eCTD Release Cycle – Required Software Changes
Valid Values
Version 2.0
Dated: 2008-08
STF DTD DTD STF Specification DTD
Version 2.2 version 1.2.1 Version 2.6.1 Version 1.4
Dated: 2004-11 Dated: 2006-10 Dated: 2008-06 Dated: 2009-08
2003 2004 2005 2006 2007 2008 2009 2010 2011
DTD STF Specification DTD
version 2.01 Valid Values
Version 2.6 Version 1.3 Version 3.0
Dated: 2003-08 Dated: 2004-11 Dated: 2008-05 Dated: 2010-06
eCTD Specification
Version 3.2.2
/ Dated: 2008-07
13. 3. Stable Software vs. Up-to-date
Software Releases
Challenges:
• The internal software release cycle has to be up-to-date with the
Standard release cycle!
• The software company must designate someone who is responsible
for the monitoring the standards!
• How do we handle older software versions if a new standard will be
released?
• How do we ensure that each release is able to handle sequences
created under older releases together with the current release?
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14. Agenda
1. Introduction Overview
2. The eCTD Standard Release Strategy
3. Stable Software vs. Up-to-date Software Releases
4. Insight into the techniques
5. What Can a Sponsor Do?
6. Conclusion
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17. 4. Insight into the Techniques
Daily Scrum
Meeting 24 hours
Backlog Tasks
expanded by 30 days
team
Sprint Backlog
Potentially
Product Backlog Shippable Product
As prioritized by Product Owner Increment
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18. Agenda
1. Introduction Overview
2. The eCTD Standard Release Strategy
3. Stable Software vs. Up-to-date Software Releases
4. Insight into the techniques
5. What Can a Sponsor Do?
6. Conclusion
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19. 5. How to ensure …
• Vendor-Audit
• Regular Vendor-Meetings
• Rigorous internal change control process
(covered in detail earlier by Don Palmer)
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20. Agenda
1. Introduction Overview
2. The eCTD Standard Release Strategy
3. Stable Software vs. Up-to-date Software Releases
4. Insight into the techniques
5. What Can a Sponsor Do?
6. Conclusion
/
21. 6. Conclusion
To handle this complex process, there must be …
• … excellent employees on board at the vendor
• … good processes installed
• … an open communication between vendor and
customers
• …well developed change control at customer
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22. Thanks …
For your attention!
Contact Information:
eMail: aobermeyer@mission3.com
Phone: +49 (0) 176 / 609 73 0 74
