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Keeping Up with Regulatory Changes

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  • 1. Keeping Up withRegulatory ChangesA Software Vendor’s ViewAndrea ObermeyerLead 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. Agenda1. Introduction & Overview2. The eCTD Standard Release Strategy3. Stable Software vs. Up-to-date Software Releases4. Insight into the techniques5. What Can a Sponsor Do?6. Conclusion  /
  • 4. Agenda 1. Introduction & Overview2. The eCTD Standard Release Strategy3. Stable Software vs. Up-to-date Software Releases4. Insight into the techniques5. 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 OverviewAdvantages of eCTD Disadvantages of eCTDOrganization of documents Expensive software solutionsOrganization and presentation of Alternative solution:metadata of separate files Time-consuming manual workMD5 checksum Changes of internal processesPossibility to create country-specific …versionsDocument lifecycle can be maintainedand various views are made possibleXML linking functionalityCopy & Paste functionalityUsage of 21 CFR part 11 compliantelectronic signatures…  /
  • 7. Agenda1. Introduction & Overview 2. The eCTD Standard Release Strategy3. Stable Software vs. Up-to-date Software Releases4. Insight into the techniques5. What Can a Sponsor Do?6. Conclusion  /
  • 8. 2. The eCTD Standard Release StrategyThere are 2 different release typesMajor Releases Minor ReleasesWill be announced at least two years before The scope of these minor releases will be tothey occur correct minor issues with the specifications that hinder standards implementation or software application developmentInclude changes that significantly impact Notification will occur when the minor releaseDTDs, major modifications to architecture, or is published on the Notice to Applicantsignificantly impact the software applicationsbeing usedWill be addressed by the Joint TIGes- Modifications introduced in the EuropeanIndustry eCTD Implementation Group and eCTD Standards to comply with CTDfollow the Change Control Process guidance will be considered minor releases and proposed by the NtA-TIGes Interlinking GroupWill be identified by a new numbering Will continue the numbering sequence of thesequence (e.g., 2.0, 3.0) last major release (e.g., 2.1, 2.3)  /
  • 9. Agenda1. Introduction & Overview2. The eCTD Standard Release Strategy 3. Stable Software vs. Up-to-date Software Releases4. Insight into the techniques5. What Can a Sponsor Do?6. Conclusion  /
  • 10. 3. Stable Software vs. Up-to-dateSoftware ReleasesThe 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 V2.3The 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-dateSoftware ReleasesThe 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-dateSoftware ReleasesThe 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-dateSoftware ReleasesChallenges:• 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. Agenda1. Introduction & Overview2. The eCTD Standard Release Strategy3. Stable Software vs. Up-to-date Software Releases 4. Insight into the techniques5. 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. Agenda1. Introduction & Overview2. The eCTD Standard Release Strategy3. Stable Software vs. Up-to-date Software Releases4. 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. Agenda1. Introduction & Overview2. The eCTD Standard Release Strategy3. Stable Software vs. Up-to-date Software Releases4. Insight into the techniques5. What Can a Sponsor Do? 6. Conclusion  /
  • 21. 6. ConclusionTo 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.comPhone: +49 (0) 176 / 609 73 0 74