Please find below details of a one-day meeting organised by PSI and International Biometrics Society.  For more information PLEASE respond to Alison Houghton using the details provided below and not to me.

 

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PSI (Statisticians in the Pharmaceutical Industry) and the International Biometric Society (British Region) are holding a one-day scientific meeting on "Statistical Aspects of Safety Data" on the 28th June 2006.

 

Current issues in drug safety will be addressed (such as QT prolongation and the use of Bayesian methods), as well as issues arising from food safety work. The meeting will be of interest to statisticians and other researchers who work in these areas, and aims to promote a wider cross-fertilisation of ideas as applied to safety signal detection.

 

The agenda is as follows:

 

09.15 - 09.45 Registration

 

09.45 - 10.25      Mechanistic basis of adverse drug reactions: the perils

of inappropriate dose schedules, Rashmi Shah, Independent Consultant

(ex-MHRA)

 

10.25 - 11.05      Probabilistic exposure assessment in food safety, Andy

Hart, Central Science Laboratory (York)

 

11.05 - 11.25   Coffee

 

11.25 - 12.05      Efficient detection of genetically-modified organisms

(GMOs) when sampling from heterogeneous bulks, Roy MacArthur, Central Science Laboratory (York)

 

12.05 - 12.35      Drug-induced QT interval prolongation: its significance

and limitations during drug development - a clinical and a statistical perspective, Rashmi Shah, Independent Consultant (ex-MHRA) and Georg Ferber, Novartis

 

12.35 - 13.35   Lunch

 

13.35 - 14.15      Relating data from the in vitro hERG assay and from dog

models to QT interval prolongation in humans, Daniel Jonker, Grunenthal GmbH

 

14.15 - 14.45      Optimising the design of thorough QT/QTc studies, 

Monica

Antunes, Novartis

 

14.45 - 15.05      QT interval prolongation - discussion

 

15.05 - 15.25   Coffee

 

15.25 - 16.05      Are Bayesian methods the solution to safety signals in

trials and pharmacovigilance ?, Stephen Evans, London School of Hygiene and Tropical Medicine

 

16.05 - 16.45      Bayesian methods in safety assessment, Deborah Ashby,

Wolfson Institute of Preventive Medicine

 

16.45         Meeting Close

 

Venue: Royal Statistical Society, 12 Errol Street, London, EC1Y 8LX

 

Registration: Please access the events page of the PSI website, choose this scientific meeting and download the registration form. The website address is www.psiweb.org.

For further information or questions about the meeting, please contact Alison Houghton, PSI Executive Office, Resources for Associations, South Park Road, Macclesfield, SK11 6SH, UK. Tel: 01625 267880 ext 228.

 

Registration Costs (fee includes lunch and refreshments):

For registration before 24th May 2006:

PSI/Biometric Society members - £52.88 (inc. £7.88 VAT) Non-members - £88.13 (inc. £13.13 VAT)

 

For registration on or after 24th May 2006:

PSI/Biometric Society members - £105.75 (inc. £15.75 VAT) Non-members - £176.25 (inc. £26.25 VAT)

 

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