Transcript Heads of Medicines Agencies: Home

Information Technology at EMEA
Current activities and the Way Ahead
Presentation to the Workshop on
Future of Telematics in Pharmaceuticals
20 April 2001
by
Thomas Lönngren, Executive Director, EMEA
EMEA IT Activities

EMEA IT
Running
internal IT system
Develop new internal systems
Develop EudraVigilance
PIM (Product information management)

ETOMEP
Support
by JRC
Web site and EudraNet
EMEA IT systems in operation


General office PC network and e-mail system
Operational systems






EMEA public catalogue documentation system
Third country export certificates database
European experts database
‘Scientific memory’ database
‘Scientific advice’ database
Administrative and support systems




ActiTrak (time-cost analysis for analytical accounting)
Financial software system
Revenue and expenditure database
Personnel database
IT systems under development
Cost
Man
estimate months
• EudraVigilance
• Project Information Management
• Personnel database
• Document management system
• SIAMED tracking system
• Meeting management system
€ 550,000
12
(internal resources)
6
€ 270,000
12
€ 1,546,000
6
€ 320,000
12
(internal resources)
6
IT systems under development
Other projects and further developments:
•
•
•
•
•
•
•
Man months
Electronic submission
6
Orphan drug database
2
Desktop videoconferencing facilities
6
GMP inspections database
2
Scientific advice and
scientific memory databases
5
European experts database
3
Other projects
2
Total = 80 man months (or 8 people)
IT financial and human resources
250
2500
200
2000
150
1500
100
1000
50
500
0
0
1995
1996
IT staff
1997
1998
EMEA staff
1999
2000
2001
IT expenditure (€ '000s)
The EU IT situation

The 3 regulatory partners are
EMEA
European
•
•
•
JRC
DG Enterprise
IDA
Member
•

Commission
States
Heads of Agencies and the MRFG/VMRFG
Overall management by Telematics Steering
Committee (chaired by Commission)
The questions?




What kind of systems are needed for the
European authorisation system?
Who is responsible for developing, running
and maintaining these systems?
Who will finance these systems?
The new management structure set up by the
European Commission has to answer these
questions (strategy currently under
preparation)
The role of EMEA

Short term
 EMEA
focus on internal needs and EudraVigilance
(in the 2002 budget)
 Maintain present cooperation with JRC

Long term
 Depends
on the coming strategy
 EMEA input to this strategy:
•
•
take EU responsibility for development, running,
maintaining and financing IT systems?
only responsible for IT under the centralised
system?