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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. Why electronic submissions Proposals for veterinary e-submissions

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Workshop on e-submissions in the veterinary sector

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  1. 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

  2. Outline of presentation • Why electronic submissions • Proposals for veterinary e-submissions • using bespoke software • using ‘standard’ software • Conclusions • Next steps

  3. 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

  4. 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

  5. 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

  6. E-submission using bespoke software • eNTA structure • Example from Part III of dossier for a pharmaceutical product

  7. 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

  8. E-submission using ‘standard’ software • NTA structure • Same example from Part III of dossier for a pharmaceutical product

  9. 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

  10. VNeeS requirements

  11. 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

  12. Next steps • Breakout sessions • Harmonisation of requirements • Validation criteria • Previous experience of e-submissions • Assistance to industry (e.g. SMEs)

  13. Next steps • Early decision – end May? • VMD willing to discuss with all • VMD will begin to draft a guidance for VNeeS

  14. The Future • Agreement now does not mean no changes • Systems can and probably will evolve over time • The proposal is the roadmap

  15. Have to be ready on 1 January 2010 Thank you for your attention

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