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.