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Keeping Up with
Regulatory Changes
A Software Vendor’s View

Andrea Obermeyer
Lead Product Manager
Disclaimer



        The views and opinions expressed in the following PowerPoint slides are
        those of the individual presenter and should not be attributed to Drug
        Information Association, Inc. (“DIA”), its directors, officers, employees,
        volunteers, members, chapters, councils, Special Interest Area
        Communities or affiliates, or any organization with which the presenter is
        employed or affiliated.

        These PowerPoint slides are the intellectual property of the individual
        presenter and are protected under the copyright laws of the United States of
        America and other countries. Used by permission. All rights reserved. Drug
        Information Association, DIA and DIA logo are registered trademarks or
        trademarks of Drug Information Association Inc. All other trademarks are
        the property of their respective owners.



   /
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


    /
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
     /
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




   /
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
…
    /
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
     /
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)
    /
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
     /
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



   /
3. Stable Software vs. Up-to-date
Software Releases
The Product Release Cycle - Example

        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




         2.1   2.0   2.1 1.6 2.0 2.1   1.5   2.0 2.1      2.0 2.0   2.1     2.1
         HF1   SP2   SP1 SP3 SP2 SP1   SP4   SP3 SP2      SP3SP3    SP2     SP3
                        HF28 HF1 HF1   HF1                HF1 HF2   HF1




   /
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
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?




   /
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
     /
4. Insight into the Techniques




   /
4. Insight into the Techniques

         /




                     



                           ^
                            



                                 /




                                     W

   /
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


     /
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
     /
5. How to ensure …


• Vendor-Audit
• Regular Vendor-Meetings
• Rigorous internal change control process
  (covered in detail earlier by Don Palmer)




   /
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


     /
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



   /
Thanks …
For your attention!



Contact Information:
eMail: aobermeyer@mission3.com
Phone: +49 (0) 176 / 609 73 0 74

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Keeping Up with Regulatory Changes

  • 1. Keeping Up with Regulatory Changes A Software Vendor’s View Andrea Obermeyer Lead Product Manager
  • 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 Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. /
  • 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 /
  • 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 /
  • 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 /
  • 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 … /
  • 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 /
  • 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) /
  • 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 /
  • 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 /
  • 11. 3. Stable Software vs. Up-to-date Software Releases The Product Release Cycle - Example 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 2.1 2.0 2.1 1.6 2.0 2.1 1.5 2.0 2.1 2.0 2.0 2.1 2.1 HF1 SP2 SP1 SP3 SP2 SP1 SP4 SP3 SP2 SP3SP3 SP2 SP3 HF28 HF1 HF1 HF1 HF1 HF2 HF1 /
  • 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? /
  • 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 /
  • 15. 4. Insight into the Techniques /
  • 16. 4. Insight into the Techniques / ^ / W /
  • 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 /
  • 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 /
  • 19. 5. How to ensure … • Vendor-Audit • Regular Vendor-Meetings • Rigorous internal change control process (covered in detail earlier by Don Palmer) /
  • 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 /
  • 22. Thanks … For your attention! Contact Information: eMail: aobermeyer@mission3.com Phone: +49 (0) 176 / 609 73 0 74