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The Future of Telematics in Pharmaceuticals. FEDESA observations Andrew Fleetwood. Points to consider. Transparency Scalability International aspects Pharmacovigilance Languages Accessibility Feasibility Partnership. Transparency.
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The Future of Telematics in Pharmaceuticals FEDESA observations Andrew Fleetwood
Points to consider • Transparency • Scalability • International aspects • Pharmacovigilance • Languages • Accessibility • Feasibility • Partnership
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
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
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
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)
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
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
Feasibility Important point to be considered: Economical resources needed should be proportionate to veterinary sector
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.