Executive Summary of the minutes of EFSPI Council meeting Maidenhead, UK
Member associations present:
Belgium, Denmark, Finland, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK
Member association absent:
David Morgan (UK)
Thanks were expressed to Ingenix for providing the room and lunch.
Thirteen Council members from ten countries attended the meeting, plus two representatives of the Executive Office.
The minutes of the previous Council meeting in Paris (April 2003) and the minutes of the Group Chairs Teleconference (September 2003) were approved.
The archive of Council documents has now been completed. CD copies were distributed to the Officers a nd to the Executive Office. Once implemented the documents will be available for all council members through the closed part of the website.
More information has been added to the EFSPI website and a schedule and process for updates has been agreed. Several companies have paid to advertise and several council members’ companies had enjoyed free adverts in order to boost the initiation of advertising. Member groups were invited to send links for their activities to be incorporated into the website.
A draft publicity poster for EFSPI was reviewed and amendments suggested. Each member group will receive 10 copies. A short article about EFSPI has been published in the Pharmaceutical Statistics Journal on paper, though it did not appear in the electronic version. It was agreed that the website will be the focus of future publicity activities.
The successful launch was noted of the Pharmaceutical Statistics Journal produced by PSI and Wiley. Member Groups are requested to encourage their members to read the journal and to contribute to it – particularly on regulatory topics.
Although there has been less activity than planned on website advertising, the overall financial situation of EFSPI is close to budget. The budget and member group fees for 2004 were agreed. Council agreed that the formula for calculating member group fees in future years should be amended to exclude the provisional “ability to pay” factor. The Officers will develop a detailed proposal for the next Council meeting.
Council confirmed its previous decision to propose to CPMP a new Points to Consider document on ‘Methodological issues pertaining to lot-to-lot consistency in vaccines’. Assistance would be offered to CPMP in drafting and/or early review of their two planned Points to Consider papers and volunteers for this task have been found. All draft input will be reviewed by Council.
A rapid response had been made on compiling comments on the finalised Points to Consider paper on Baseline Covariates to make CPMP aware of EFSPI’s concerns. A team was initiated to make comments on the expected consultation version of the ICH E14 document on QTC intervals.
Contact had been re-established with the PhRMA Biostatistics and Data Management subgroup. Feedback was given to their request for input on topics to discuss with the FDA.
Plans for upcoming DIA meetings and possible suggestions for program chairs to ESAC were discussed.
The Qualifications and Training Working Party has started its programme of work. A document with an overview on qualifications is anticipated by the end of the year.
In accordance with the planned succession, the Presidency of EFSPI was transferred to Merete Jorgensen (Denmark), who expressed her appreciation to David Morgan (UK) for all his work as President over the last two years.
The next Council meeting was scheduled for April 2004 in Dublin, Ireland.
CPMP Committee for Proprietary Medicinal Products (of the EU)
ESAC European Statistical Advisory Group (for DIA)
FDA Food and Drug Administration
ICH International Conference on Harmonisation
PhRMA Pharmaceutical Research and Manufacturers Association (US)
PSI Statisticians in the Pharmaceutical Industry (UK)