Workshop on e submissions in the veterinary sector
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Workshop on e-submissions in the veterinary sector. A proposal for electronic submission for veterinary medicines. Neil Paterson, David Lewsey and Alex Tait Veterinary Medicines Directorate, UK. Outline of presentation. Why electronic submissions Proposals for veterinary e-submissions

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Workshop on e-submissions in the veterinary sector

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Workshop on e submissions in the veterinary sector

Workshop on e-submissions in the veterinary sector

A proposal for electronic submission for veterinary medicines

Neil Paterson, David Lewsey and Alex Tait

Veterinary Medicines Directorate, UK


Outline of presentation

Outline of presentation

  • Why electronic submissions

  • Proposals for veterinary e-submissions

    • using bespoke software

    • using ‘standard’ software

  • Conclusions

  • Next steps


Why electronic submissions

Why electronic submissions

  • Industry request to HMA

  • Benefit to both regulators and industry

    • reduction of administrative burden (paper)

    • reduction of storage space

    • facilitation of assessment and review process

    • product lifecycle management

  • Accept e-submission by 1 Jan 2010


Vmd proposal for e submissions

VMD proposal for e-submissions

  • Based on common sense

  • Simple system based around way things work now

  • Builds on specification agreed by industry and regulators

  • Suitable for companies of all sizes


E submission using bespoke software

E-submission using bespoke software

  • For reviewers based on EURS is Yours

  • Basic structure based on NTA (eNTA)

  • Natural evolution from paper to electronic format

  • Lifecycle management built in

  • Granularity

    • only 3 levels


E submission using bespoke software1

E-submission using bespoke software

  • eNTA structure

  • Example from Part III of dossier for a pharmaceutical product


E submission using standard software

E-submission using ‘standard’ software

  • An electronic submission but not eNTA

  • A VNeeS based on an agreed standard

  • Structure still in line with NTA

  • Lifecycle management as for paper

  • Granularity

    • 2 levels


E submission using standard software1

E-submission using ‘standard’ software

  • NTA structure

  • Same example from Part III of dossier for a pharmaceutical product


Vnees

VNeeS

  • Advantages

    • same as already doing with paper

    • an interpretation of the already agreed specification for electronic dossiers

    • potential for import into EURS is Yours

    • simple structure

  • For example


Vnees requirements

VNeeS requirements


Conclusions

Conclusions

  • A single EU solution to e-submissions is needed

  • Can be used by all

  • Natural evolution from paper

  • Adaptability

  • Choice and flexibility

  • VMD believe it will work


Next steps

Next steps

  • Breakout sessions

    • Harmonisation of requirements

    • Validation criteria

    • Previous experience of e-submissions

    • Assistance to industry (e.g. SMEs)


Next steps1

Next steps

  • Early decision – end May?

  • VMD willing to discuss with all

  • VMD will begin to draft a guidance for VNeeS


The future

The Future

  • Agreement now does not mean no changes

  • Systems can and probably will evolve over time

  • The proposal is the roadmap


Workshop on e submissions in the veterinary sector

Have to be ready on 1 January 2010

Thank you for your attention


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