The Future of Telematics in Pharmaceuticals

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.