1 / 10

The Future of Telematics in Pharmaceuticals

The Future of Telematics in Pharmaceuticals. FEDESA observations Andrew Fleetwood. Points to consider. Transparency Scalability International aspects Pharmacovigilance Languages Accessibility Feasibility Partnership. Transparency.

lakia
Télécharger la présentation

The Future of Telematics in Pharmaceuticals

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The Future of Telematics in Pharmaceuticals FEDESA observations Andrew Fleetwood

  2. Points to consider • Transparency • Scalability • International aspects • Pharmacovigilance • Languages • Accessibility • Feasibility • Partnership

  3. Transparency • Many telematics initiatives are in progress under an overall strategy • industry not familiar with management structure • not all initiatives are understood by industry • therefore difficult to constructively comment • Proposal: • Open telematics web site to engage industry and encourage comment/ input

  4. Scalability • Limited resources in veterinary pharmaceutical industry • Need to deal with “legacy” documents (eg MRLs and generic applications) • Proposals: • developments in telematics should encourage use of IT without placing unintentional barriers • open web site to encourage even smallest companies to be involved

  5. International dimension • Use of telematics being considered in other territories/ arenas (e.g VICH, US CVM) • Particular note: e-compliance (21CFR11), e-submissions, e-CTD/ ICH/VICH • Proposals: • track/ consider/ collaborate in developments in other arenas • make full use of VICH process

  6. Pharmacovigilance • Industry supports the development of a robust EU pharmacovigilance system based on telematics • Looking to this replacing need for 5-yearly renewals • Proposal: • industry ready to play its part in supporting development of the system (incl. international dimension)

  7. Languages • Current systems produce significant hurdles to smaller companies (and larger ones!) • Situation will approach melt-down with accession to EU • Easy opportunities to make improvements • Proposal: • Industry will work with agencies to develop pragmatic and workable solutions

  8. Accessibility • Current websites are difficult to navigate and not well linked together • Technical performance of HEVRA website could be improved • Proposal: • co-ordinated plan to update websites and ensure all are appropriately resourced

  9. Feasibility Important point to be considered: Economical resources needed should be proportionate to veterinary sector

  10. Partnership • Involving industry by intellectual partnership produces good results • e.g. EPARs, PIM/x-Dossier initiative, VICH • Transparency is the key to partnership and involvement and is FEDESAs overriding goal.

More Related