1. 1 Future strategy for e-submission as seen by industry Dr Michael Colmorgen, IFAH-Europe 2nd Veterinary Workshop on E-submission 4 Dec 2009, EMEA, London

2. 2 Future of e-submission What is your feeling about e-submission approaching your daily work?

3. 3 Future of e-submission IFAH Europe is supporting e-submission as it offers a lot of chances for an effective dossier compilation and assessment process but for any future development constant care on the constraints and impact on the animal health sector is needed

4. 4 Future? What comes next on short term? First establish VNeeS …! 2010 will be a learning phase for both industry and regulators and close cooperation is needed Establish appropriate document conventions or check lists for successful e-submission Use suitable word-processing features to facilitate PDF creation (this needs also to be considered for regulatory templates like QRD templates) Gather experience how to handle lifecycle procedures (variations, extensions, renewals… )

5. 5 Future? What comes next on short term? And then …? It is advised to first implement the current projects before moving to more complex systems like eNTA

6. 6 eAF – The next step in 2010 Electronic application forms (eAF) Basically welcomed, IFAH-Europe involved since 2008 Introduction of XML, allowing electronic exchange of structured information Complex project due to interfacing, e.g. link with EU TCT (EU Telematics Controlled terms) Benefit of this project is appreciated, like easy user interface, pre-populating fields out of an XML-file, dynamic forms or validation tools Chance for harmonisation especially in terms of translation

7. 7 eNtA – The next specification? eNTA Still early phase of development CONCEPT basically following eCTD Offering additional lifecycle support through XML metadata May offer advantages mainly for assessors but potentially also for industry - e.g. convenient views of consolidated current dossier Simpler dossier structure and simpler specification compared to eCTD

8. 8 eNtA – The next specification? eNTA (continued) BUT eNTA requires the use of a bespoke software may have limited advantage when implemented only for new products if major scope is lifecycle – consequences of retrospective application? use is restricted to Europe and size of the veterinary dossier is not the same as for a human product less benefits than from eCTD!

9. 9 eNtA – The next specification? eNTA (continued) a key to success for this system is harmonisation and two or three systems (VNeeS and paper) are not easy to manage on a long term Option to completely remove paper submission? (Legal basis to be created?)

10. 10 eNtA – The next specification? eNTA (continued) IFAH-Europe supports further activities on eNTA project but strongly recommends to Define user requirements up-front to get a proper understanding of the exact goals, both for industry and authorities Do a thorough impact assessment before implementation

11. 11 EU Central Repository Web Portal / Central repository Clearly supported by IFAH-Europe Offers further chances for harmonisation, but … only if it is used by all regulators (EMEA and NCAs)! Link to transparent process tracking systems? Single point of reference for the dossier Solves security issues with transport of CDs / DVDs

12. 12 International Harmonization Further harmonization of requirements Goal to use one system across all agencies in the EU But dont forget about international Harmonisation… VICH? At least common agreement about basic file standards should be achievable across regions.

13. 13 Conclusions? Dont follow new paths without thorough reflection on potential impact …

14. 14 Conclusions – The future IS e-submission IFAH-Europe is fully supporting e-submission projects Some corner points need always be taken into consideration: 1.Establish industry and regulators requirements first 2.Always establish clear benefits for industry and regulators e.g. concerning increase of efficiency or increase of transparency

15. 15 Conclusions – The future IS e-submission 3.Careful impact assessment – Consider also resources in the veterinary sector and that there is often no specialized staff for publishing / e-submission available 4.Dont lose the goal of simple solutions - technology will keep evolving but not everything that is doable in terms of IT should be done 5.Developed standards need to be robust and sufficiently stable over time

16. 16 Conclusions – The future IS e-submission 6.A key for success is harmonisation. The development of the 1-1-1 concept could bring a significant advantage in this domain. 7.Last but not least - continue successful collaborative industry / agency approach in TIGes veterinary subgroup!

17. 17 Thank you for your attention! Any further thoughts? Questions? Comments?