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

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Future strategy for e-submission as seen by industry

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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


Future of e-submission

What is your feeling about e-submission approaching your daily work?


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


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… )


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


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, likeeasy user interface, pre-populating fields out of an XML-file, dynamic forms or validation tools

  • Chance for harmonisation especially in terms of translation


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


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!


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?)


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


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


International Harmonization

Further harmonization of requirements

  • Goal to use one system across all agencies in the EU

  • But don’t forget about international Harmonisation…

  • VICH? At least common agreement about basic file standards should be achievable across regions.


Conclusions?

Don’t follow new paths without thorough reflection on potential impact …


Conclusions – The future IS e-submission

IFAH-Europe is fully supporting e-submission projects

Some corner points need always be taken into consideration:

  • Establish industry and regulators requirements first

  • Always establish clear benefits for industry and regulators e.g. concerning increase of efficiency or increase of transparency


Conclusions – The future IS e-submission

  • Careful impact assessment – Consider also resources in the veterinary sector and that there is often no specialized staff for publishing / e-submission available

  • Don’t lose the goal of simple solutions - technology will keep evolving but not everything that is doable in terms of IT should be done

  • Developed standards need to be robust and sufficiently stable over time


Conclusions – The future IS e-submission

  • A key for success is harmonisation. The development of the 1-1-1 concept could bring a significant advantage in this domain.

  • Last but not least - continue successful collaborative industry / agency approach in TIGes veterinary subgroup!


Thank you for your attention!

Any further thoughts?

Questions?

Comments?


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