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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

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

Future of e-submission

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


Future of e submission1

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

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 term1

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

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 – 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 specification1

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 specification2

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 specification3

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

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

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

Conclusions?

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


Conclusions the future is e submission

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 submission1

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 submission2

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!


Future strategy for e submission as seen by industry

Thank you for your attention!

Any further thoughts?

Questions?

Comments?


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