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.