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3.3.1. Desirability and main advantages of a European EFS...

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    3.3.1. Desirability and main advantages of a European EFS program

    Overall, all the members of the panel agreed that an EFS program would be highly desirable in Europe and unanimously supported the implementation in Italy of a pioneering framework for EFS to be used as a pilot experience for Europe. Indeed, both during the individual interviews and the panel discussion, several potential contributions for a European EFS program were identified, subsequently grouped into two broad themes. The first relates to the definition of a dedicated administrative procedure and an ad hoc, standardized framework for the successful initiation and conduction of EFS in Europe, to maximize the efficiency of evidence generation processes. The introduction of clearer rules for the submission and management of EFS was considered favorable as it would allow greater certainty for the sponsors regarding the requirements to initiate a study, documentation to be produced, procedures in place, and especially the timing of each step in the process from first contact with the competent authority through definitive study evaluation and decision. Such a program would also help overcome the limits of the traditional pathway characterized by poor interaction between the competent authority and sponsors during the application process for a study. The possibility of instituting continuous, dynamic dialogue within an established procedural framework was perceived as better suited to promote real exchange on and mutual understanding of the characteristics of the innovation and the proposed evidence generation plan. Such dialogue was seen to foster reciprocal knowledge and trust between manufacturers, investigators, and regulatory authorities. In addition, mirroring the FDA EFS program, the possibility to introduce specific procedures for managing changes to the study protocol or modifications to investigational devices was also perceived to increase flexibility, in keeping with the early stage of development of the technology and the ultimate purpose of EFS.

    The second theme relates to the ability of an EFS program in Europe to attract R&D investment and strengthen the biomedical sector’s competitiveness, especially for micro, small, and midsize enterprises. The board members also highlighted that early experience with new technologies on the part of clinicians and sites facilitates the subsequent undertaking of pivotal studies, generating a multiplier effect for personnel skills and competencies and attracting capital investment.

    Importantly, among the panel there was consensus that these types of studies should not supplant informative nonclinical testing or in any way reduce the acceptability level of clinical studies, i.e. in terms of the amount of successfully conducted preclinical tests needed to initiate a clinical study, the required level of evidence on device safety, or the expected risk–benefit ratio for the patient. Rather, EFS should enhance the efficiency of evidence generation processes by limiting non-informative investigations and maximizing returns of studies in terms of information gathered to reduce uncertainties regarding the devices investigated.


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