ࡱ> ~( / 0LDTimes New Roman̳0~0  @n?" dd@  @@`` x<<     c $3@8Ug4*d*d~0&&ppp@  <4BdBd<4!d!d:2___PPT9/ 0? %+The Future of Telematics in Pharmaceuticals $FEDESA observations Andrew FleetwoodPoints to considerpTransparency Scalability International aspects Pharmacovigilance Languages Accessibility Feasibility Partnershipqq/0 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/ inputnF_. IF_.  3I3,  9 ScalabilityTLimited 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>  33,^7  International dimensionUse 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 processlS* [S* 3[3  PharmacovigilanceIndustry 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)\^Z5Z ZhZ^5 3h3,1   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@M 3L3 AccessibilityCurrent 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 resourced6P 3P3 C   Feasibility     PartnershipInvolving 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.:E,WE,W,J`* ` ff33f` ffD3f` MMM` f3fD"Yf` f3f6f3f` 3f̙f>?" dd@,|?" dd@   " @ ` n?" dd@   @@``@n?" dd@  @@``PR    @ ` ` p>> && o&(     H2,$@  0>   0e0e     ?B)CDElFt @ 5% 8c8c     ?1 0u0@Ty2 NP'p<'p @A)BCD|E?||c $)6N_i> _4% #j +  y  p  d(78@ #  3 0e0e     ?BCnDEF @ 5% 8c8c     ?1 0u0@Ty2 NP'p<'p @A)BCD|E?||//  MoK0YVS_^tT, [v] T5  G r C  ]smm#h g:Y/x|!  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