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Questionnaire on Current Status of the Use of e-Submissions by AVC Members

Association of Veterinary Consultants | 2009. Questionnaire on Current Status of the Use of e-Submissions by AVC Members. Presented by: Dr. Klaus Hellmann. e-Submission Workshop TIGes Vet Group EMEA, London May 7th, 2009. Association of Veterinary Consultants | 2009.

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Questionnaire on Current Status of the Use of e-Submissions by AVC Members

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  1. Association of Veterinary Consultants | 2009 Questionnaire on Current Status of the Use of e-Submissions by AVC Members Presented by: Dr. Klaus Hellmann e-Submission Workshop TIGes Vet Group EMEA, London May 7th, 2009 EMEA, London

  2. Association of Veterinary Consultants | 2009 Objective of Questionnaire • Quesions as agreed within the TIGes Vet Group • Sent to 46 members in March 2009 • ~ 15 AVC members actively involved in compiling dossiers or consulting clients in regulatory affairs associated to it • Nine members completed Questionnaire EMEA, London

  3. Association of Veterinary Consultants | 2009 Results of Questionnaire EMEA, London

  4. Association of Veterinary Consultants | 2009 Remaining Obstacles • Not to be the first to try • Comittment to „real“ harmonisation by NCAs • Need for clear and simple harmonised format requirements • Compatibility with client‘s software tools • Concern about costs for implementing such software • Security concerns regarding e-dossiers EMEA, London

  5. Association of Veterinary Consultants | 2009 Further Proposals • Technical Support by EMEA SME Office EMEA, London

  6. Association of Veterinary Consultants | 2009 Conclusion • AVC members highly interested • Concerns relating to current approach of NCA • Concerns relating costs and selecting, implementing, using and facilitating the most appropriate tool • Larger CROs using e-submissions according to current guideline, where possible EMEA, London

  7. Association of Veterinary Consultants | 2009 Thank you. Questions? www.avc.atpresident@avc.atsecretary@avc.at EMEA, London

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