ectd Tools Compatibility and Interoperability: Discussion and Practical Experience

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1 ectd Tools Compatibility and Interoperability: Discussion and Practical Experience Gabriel Bohl, Regulatory Affairs Manager, Quintiles, France DIA EDM 3-4 Dec 2009 Vienna

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 1. INTRODUCTION Agenda 1. What is an interoperable ectd tool? 2. Why is interoperability so important? 2. ETICS initiative 1. What is ETICS? 2. Why ETICS? 3. What is ETICS program? 4. Participating Vendors 5. What is ETICS Study conclusion? 6. What is ETICS Study Outcome? 3. CASE STUDY: Validation process and discussion 1. Scope 2. Objectives 3. Steps 4. Qualification protocol 5. Validation errors 6. Conclusion 3

4 INTRODUCTION 1. What is an interoperable ectd tool? 2. Why is interoperability so important? 4

5 What is an interoperable ectd tool? ectd Tool A ectd Tool B XYZ 0XYZ 0XYZ+N 5

6 Why is interoperability so important? Recent changes faced by the pharmaceutical industry: Nearly 600 pharmaceutical industry Mergers & Acquisitions took place between the beginning of 2007 and the end of the first quarter of 2009 (Mega-Mergers: Executing Change in the Pharma Industry - Published: 2009/06) The current economic field is in favor of the increase of Mergers & Acquisitions: "2009 is set to redefine the structure and dynamics of the pharmaceutical industry in a way not seen since the year 2000" 6

7 ETICS initiative 1. What is ETICS? 2. Why ETICS? 3. What is the ETICS program? 4. Participating Vendors 5. What is ETICS Study conclusion? 6. What is ETICS Study Outcome? 7

8 What is ETICS? November 2005, the ICH M2 ESTRI (Electronic Standards for the Transfer of Regulatory Information) Expert Working Group initiated a special project to study interoperability of ectd tools. The sub-group was named ETICS (ectd Tools Interoperability and Compliance Study). ETICS I: 2006 (US + EU) ETICS II: 2008 ( + Japan + Canada) 8

9 Why ETICS? Multiple ectd tool vendors and their interpretations of guidances: ICH ectd specifications Regional specifications Q&As (ICH and Regional) Other Contributing factors: Changing business rules Ambiguous specifications Some lifecycle issues undefined All of this leading to: Incorrect building of ectds Incorrect validation of ectd with risk of non-acceptance: Missed negatives False positives 9

10 ETICS I: What is the ETICS program? Test Interoperability between ectds Test Compliance to the ICH validation criteria (Q36 checks) Phase 1: Files provided to create 2 ectds (US and EU). Phase 2A: ectds with intentional errors to be tested. Phase 2B : ectds Phase 1 available to other vendors Interoperability issues were identified. ETICS II: ETICS I results: problems with ICH Q36 checks + Interpretation of ICH specifications too rigid or too vague Phase 1: sample files to vendors and instructions to create an ectd. Phase 2: vendors access to ectds created by other vendors/tools created in Phase 1. Will also be provided with ETICS ectds. 10

11 Participating Vendors ETICS II: list of vendors : 14 tools C6 Mission 3 Datafarm,,,,,,,,,,,,, Octagon Doublebridge Open Text Educe Thomson Extedo Virtify IBM ISI Lorenz MedXView 11

12 What is ETICS Study conclusion? Well established vendors better than new tools ectds better for US and EU CP, less with EU MRP, Canada and Japan Need more guidance (ICH and Regional) Validation: ICH and EU change requests Scan resolution (EU) check unstable Empty titles not allowed (EU) ICH recommendation on PDF Opening settings (answered in ICH Q&A) 12

13 What is ETICS Study Outcome? Changes to the ICH Q&A in June 08 Changes to EU Validation Criteria in July 08 Discussions on other new EU guidances Several points being brought into the development of the ectd NMV/RPS 2 IRISS open forum 13

14 CASE STUDY: process and discussion 1. Scope 2. Objectives 3. Steps 4. Qualification protocol 5. Validation errors 6. Conclusion 14

15 Scope 1. To transfer ectd submissions from Company A to Company B 2. To define a Qualification Protocol including validation steps on the initial existing ectd submissions by using the new ectd Tool 3. To run the validation tests using the new ectd Tool 4. To create a sample Life Cycle Management ectd sequence 15

16 Objective To guarantee that the already submitted ectd applications are well recognized with the new ectd Tool To guarantee that Life Cycle Management submissions can be created 16

17 Steps 1. Acquire complete copies of ectd submissions from Company A 2. Load the sequences on the ectd Tool 3. Run validation on the ectd submissions (10%) 4. Create a new sequence to see if it validates properly 17

18 Qualification protocol (1/2) Test script defined by the client: 1. All previous sequences are stored in a secure area (publishing area) Acceptance criteria: The list of sequences and total number of files are compared against the inventory sent (Windows explorer) 2. All previous sequences are seen in ectd Builder/Viewer Acceptance criteria: All previous sequences are listed in the available sequences while in the ectd Builder/Viewer 18

19 Qualification protocol (2/2) 3. Validation reports are to be generated. Acceptance criteria: Validation report shows no unexplained error (on 10% of the sequences) 4. New sequence created successfully and document with append operation can be added. Acceptance criteria: No error messages and clean validation report. 19

20 Example of Validation errors found 1. Write permissions 2. XML language order 3. Missing files 20

21 Validation error 1 = Write permission Error identified: Explanation: All of the files in the util folder (stylesheets and DTD) and the XML index are open-read only. Solution: Right click on the file, select properties, and unclick read-only. 21

$> And it should look like this: Solution: <?xml-stylesheet type="text/xsl" href="util/style/ectd-2-0.xsl"?> look at the XML Index in the \submission folder (open it with Notepad).$

22 Validation error 2 = xml language order Error identified: Explanation: A section of the xml language look like this: <?xml-stylesheet href="util/style/ectd-2-0.xsl" type="text/xsl"?> And it should look like this: Solution: <?xml-stylesheet type="text/xsl" href="util/style/ectd-2-0.xsl"?> look at the XML Index in the \submission folder (open it with Notepad). Copy and paste the correct line only. Save. 22

$\util\style folder or dtd folder.$

23 Validation error 3 = Missing files Error identified: Explanation: Missing style sheet or DTD file in util folder Solution: Place a copy of missing DTD or style sheet in the DTD or style folder. \util\style folder or dtd folder. Rerun the validation to get this message: 23

Conclusion 1. Summary of the qualification protocol: 1. 100%: ectd sequences recognised by the new tool 2.

24 Conclusion 1. Summary of the qualification protocol: %: ectd sequences recognised by the new tool 2. 10% of successful validation reports on previous sequences with no significant error = MOST PROBLEMATIC %: validation report clean on new ectd sequences 2. Validation errors on previous sequences 1. Discovered on the field 2. Not always an explanation for the validation error found 3. Need ectd tool vendor hot line 76 new sequences submitted! 24

26 Resources esubmission.emea.europa.eu estri.ich.org 26

1 2 December esubmissions? 1. How can baseline dossiers support global esubmissions? Disclaimer. What is a baseline submission?

1 2 December esubmissions? 1. How can baseline dossiers support global esubmissions? Disclaimer. What is a baseline submission? How can baseline dossiers support global Hans van Bruggen www.ectdconsultancy.com How can baseline dossiers support global 1 Disclaimer The views and opinions expressed in the following PowerPoint slides