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ALLSTAT  December 2008

ALLSTAT December 2008

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Subject:

PSI Training Course - Data Monitorting Committees - 10 & 11 March 2009

From:

Jenny Butterworth <[log in to unmask]>

Reply-To:

Jenny Butterworth <[log in to unmask]>

Date:

Tue, 23 Dec 2008 11:52:03 -0000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (79 lines)

> Dear Allstat
> A PSI TRAINING COURSE ON DATA MONITORING COMMITTEES BY MARY FOULKES &
> SIMON DAY - 10 & 11 MARCH 2009 
> This is a reminder that we have places available on the 2-day training
> course " Data Monitoring Committees" on 10th & 11th March 2009,
> presented by Mary Foulkes & Simon Day at Denham Grove, Tilehouse Lane,
> Denham, Buckinghamshire, UB9 5DU. 
> To guarantee your accommodation for the course please book before 6th
> January 2009. All accommodation requests made after this date cannot
> be guaranteed. 
> This course will focus on practical issues around the workings of data
> monitoring committees. It is relevant to all those who need to set up
> DMCs and work with them throughout the course of a trial or of a full
> development programme. The following key topics will be addressed: 
> 
> *	Formal interim analyses, 'administrative' interim analyses,
> safety monitoring
> *	Arguments for and against stopping trials early (scientific
> issues, ethical, regulatory)
> Regulatory guidance
> *	CHMP and FDA
> *	Other guidance (e.g. WHO, NIH)
> *	Interaction with regulators; what regulators might and might not
> do (and when)
> Overview of group sequential methods
> *	Stopping 'rules'
> *	Haybittle and Peto, Pocock, O'Brien and Fleming, alpha-spending
> approach
> *	Bayesian methods
> How do DMC meetings run?
> *	Frequency, location, structure, attendance
> *	Conduct and communication
> *	Practical problems (dissemination of information (including
> minutes), independence, communications)
> 
> Register online at www.psiweb.org and click onto Events to confirm
> your place. To receive your earlybird discount, register by 2nd
> February 2009. Payment is now available online. 
> For those unfamiliar with the location, the hotel is easily accessible
> by train and car, and from airports. Please find details below
> By Car
> From the South and M4, head north to Junction 16 on the M25 then join
> the M40 eastbound. Proceed to Junction 1 and follow the A40 (Gerrards
> Cross) then turn right onto the A412 at the traffic lights. Turn into
> Tilehouse Lane (second left). Continue for about 1 & 3/4 miles. Denham
> Grove is on the right. 
> 
> From the North and M1, follow the M25 to Junction 17. Join the A412
> southbound. Continue for about 3 & 1/2 miles then turn right into
> Denham Green Lane. When you reach the T junction turn right into
> Tilehouse Lane. Continue for about 1/2 of a mile. Denham Grove is on
> the right.
> By Train
> Trains run from Marylebone to Denham station. Piccadilly or
> Metropolitan lines run to Uxbridge or Rickmansworth
> By Air
> Heathrow (15 miles) and Gatwick (60 miles) are within easy reach.
> Website Address:
> http://www.deverevenues.co.uk/find-venue/denham-grove.html
> We look forward to receiving your registrations. 
> Kind regards 
> PSI Executive Office 
> PSI Events Co-ordinator
> Tel: +44 (0)1625 267882 Fax: +44 (0)1625 267879 
> Resources for Associations Ltd 
> Registered Office: South Park Road, Macclesfield, SK11 6SH 
> Registered in England No. 4391074 
> 
> This email and any files transmitted with it are confidential and
> intended solely for the use of the individual or entity to whom they
> are addressed. If you have received this email in error please notify
> the system manager. Please note that any views or opinions presented
> in this email are solely those of the author and do not necessarily
> represent those of RfA Limited. Finally, the recipient should check
> this email and any attachments for the presence of viruses. RfA
> Limited accepts no liability for any damage caused by any virus
> transmitted by this email. 
> 

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