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INTERNATIONAL MEDICAL STATISTICS CONFERENCE, LEICESTER UK
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Statistical Issues in Biopharmaceutical Environments :
Towards the New Millennium
28 - 30 July 1999
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CONFERENCE TOPICS :
* Regulatory and Statistical Issues in Drug Development
* Impact of International Guidelines
* Data Monitoring Committees
* Data Management and Technology
* Categorical Data and Repeated Measures
* Current Issues - Exact Methods, Bioequivalence,
Sample Size Re-estimation
INTRODUCTION
The Department of Medical Statistics in the Faculty of Computing Sciences
and Engineering, De Montfort University, Leicester, aims to serve as a
centre of excellence for research, consultancy and teaching in medical
statistics and medical systems. CliniStat, the consulting and training
arm of the department, provides an important stimulus for research
through close links with both the pharmaceutical industry and hospital
research departments. The department has long played a leading role in
postgraduate education in medical statistics in the UK. Four Visiting
Professors, Gary Koch, John Lewis, Jim Lindsey, and George du Boulay CBE,
collaborate with staff in the department on a wide range of research issues
in medical and pharmaceutical statistics. This important international
conference builds on the acknowledged success of both the 1996 Statistical
Issues in Biopharmaceutical Environments : USA and European Perspectives
Conference and the 1997 Burning Issues in Medical Statistics Conference.
AIM OF THE CONFERENCE
Statistical issues continue to play an increasing role in the development,
testing and marketing of drugs in the pharmaceutical industry.
The Conference aims to provide the opportunity for discussion and debate
of key issues in biopharmaceutical statistics.
WHO SHOULD ATTEND
The Conference will provide a major forum for statisticians and
biometricians working in the pharmaceutical industry, research institutes,
hospital departments and academic statisticians with biopharmaceutical
research and consultancy expertise. Conference delegates will benefit from
the experience of listening to the leading speakers making presentations
on the most relevant up-to-date issues together with the opportunity to
take full part in discussion.
CONFERENCE VENUE
Statistical Issues in Biopharmaceutical Environments : Towards the
New Millennium will be held in the Queens Building, De Montfort University,
Leicester, named 1995 "Green Building of the Year". Opened by Her Majesty
the Queen in December 1993, the Queens Building is the largest naturally
ventilated building in Europe and has been hailed as ' the most innovative
and exciting new piece of architecture in Britain' today. Architects and
engineers worked closely together on the design to achieve a building that
is both energy efficient and attractive. The internal environment was
simulated using both physical and mathematical models. The building occupies
a prominent site near the heart of the city and provides classrooms, meeting
rooms, offices, laboratories and two auditoria for 150 people. It provides
an ideal location for a major international conference.
CONFERENCE FEES
The Conference Fee of 595 UK pounds ex VAT (699.13 UK pounds inc VAT)
INCLUDES registration; welcome buffet, coffee, lunch, tea; the Conference
Dinner on Wednesday 28th July and the Dinner Excursion on Thursday 29th July.
CONFERENCE AND EXCURSION DINNERS
The Conference Dinner will be held on Wednesday evening in the spacious
Leicestershire Suite at the Holiday Inn, allowing delegates maximum
opportunity to enjoy good food, wine and conversation. On Thursday there
is the Evening Excursion to Scalford Hall, in the Leicestershire
countryside. Here delegates can enjoy aperitifs, music and dinner at the
former hunting lodge of Lt Colonel Colman whose fame was derived from the
family business manufacturing English mustards.
During the 1930's Colonel Colman befriended Prince Edward, future King of
England and both the Prince and Mrs Simpson were regular visitors. It is
worth noting that the Prince's bedroom at the Hall had its own staircase.
Dress for both Wednesday and Thursday evening will be 'Jacket and Tie'.
A very limited number of guest tickets are available, at extra charge,
for the Conference and Excursion dinners. These will be allocated on a
first-come first-served basis.
ACCOMMODATION
Three nights Bed and Breakfast accommodation (Tuesday 27th -
Thursday 29th July inclusive) is available at the recommended hotel,
the Holiday Inn Leicester, at a specially negotiated total cost of 190 UK
pounds ex VAT (223.25 UK pounds inc VAT). Extra nights bed and breakfast
can also be arranged at the rate of 65 UK pounds ex VAT (76.38 UK pounds
inc VAT) per night. All rooms are well appointed with private bathroom,
individually controlled heating and air conditioning, radio, colour TV with
in-room movies, minibar, trouserpress, hairdryer, tea/coffee making facilities
and direct dial telephone. The health and leisure club's facilities include
a swimming pool, jacuzzi, spa bath, sauna and gymnasium.
Non smoking rooms are available.
Bed & breakfast accommodation is also available for accompanying partners,
sharing their partner's double room, at a special rate of 12.50 UK pounds ex VAT
(14.69 UK pounds inc VAT) per night.
SCIENTIFIC PROGRAMME COMMITTEE
CHAIRMAN : Professor Byron Jones
(De Montfort University, Leicester)
Proceedings of the Conference will be published in a special issue of
Statistics in Medicine
LOCAL ORGANISING COMMITTEE
Byron Jones, Derek Teather, Briony A Teather
Enquiries of a scientific and/or technical nature should be directed to
Professor Byron Jones on Fax +44 (0)116 250 6114 or E-Mail [log in to unmask]
Enquiries of an administrative nature, including registration, fees,
accommodation, travel etc should be directed to Dr Briony Teather on
Fax +44 (0)116 250 6114 or E-Mail : [log in to unmask]
CONFERENCE TIMETABLE (All sessions will include open floor discussion)
Tuesday 27th July 1999
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19.00-22.00 Registration and Welcome Buffet
Wednesday 28th July 1999
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9.00 - 9.45 Registration
9.45 - 10.55 Opening Session
A.Agresti Small sample exact analysis of categorical data :
Recent advances and continuing controversies
10.55 - 11.25 Coffee
11.25 - 12.45 Impact of International Guidelines
Speakers : J.Lewis
B.Louv
12.45 - 14.15 Lunch, Fletcher Suite
14.15 - 15.35 Sesion 3
G.Koch Nonparametric analysis of covariance
J.Rohmel Statistical investigations on FDA & CPMP guidance to
demonstrate non-inferiority anti-bacterial drugs
15.35 - 16.00 Tea
16.00 - 18.00 Session 4
M.Becker Imputation strategies for analysis of incomplete
longitudinal data
L.LaVange Applying sample survey methods to clinical trials
using SUDAAN
C.Mehta Exact Monte Carlo methods
20.00 for 20.30 Conference Dinner, Leicestershire Suite, Holiday Inn
Thursday 29th July 1999
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9.00 - 9.55 Keynote Session
S.Ellenberg Issues surrounding independent data monitoring committees
10.00 - 11.20 Sample size re-estimation
Speakers : L.Gould
J.Denne
11.20 - 11.45 Coffee
11.45 - 13.05 Session 7
A.Grieve The future of Bayesian statistics in the
pharmaceutical industry
J.Lindsey Modelling Pharmacokinetic data
13.05 - 14.30 Lunch, Fletcher Suite
14.30 - 16.30 Impact of new technologies on Biometrics
and Data Management
Speakers : S.Ruberg
R.Marks
M.Burgess
16.30 - 17.00 Tea
17.00 - 17.55 Keynote Session
P.Armitage Theory and practice in medical statistics
19.15 Dinner Excursion to Scalford Hall-
Executive Coaches departing from Holiday Inn
Friday 30th July 1999
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9.30 - 10.50 Session 10
G.Enas Enhancing the value delivered by the statistician
throughout clinical drug development
K.Facey Integrating statistical expertise into regulatory
submissions
10.50 - 11.15 Coffee
11.15 - 12.35 Session 11
Y.Ohashi Design of early phase cancer trials
T.Sato Randomisation-based estimation of treatment effects
12.35 - 14.00 Lunch, Fletcher Suite
14.00 - 14.55 Keynote Session
S.Senn Statistical issues in bioequivalence
REGISTRATION
To reserve a place at the conference please complete the attached
registration form and send it, together with your appropriate
remittance (see payment details), to :-
Dr Briony A Teather,
Executive Secretary SIBE'99 Conference
Department of Medical Statistics
De Montfort University
The Gateway
Leicester LE1 9BH, UK Fax : +44 (0) 116 250 6114
Email : [log in to unmask]
Delegates are encouraged to register early as the number of delegates
will be restricted to 120 allowing delegates maximum opportunity for full
participation in the conference and associated programme.
JOINING INSTRUCTIONS
Full joining instructions, programme details, travel directions, maps and
details of accommodation bookings will be sent to delegates prior to the
conference.
REGISTRATION CONDITIONS
Conference bookings and accommodation reservations will only be confirmed
after a registration form and associated payment have been received. Please
note that the organisers reserve the right to refuse admission to any
delegate who has not paid his/her fees in full prior to the conference.
Full refunds of the conference and associated accommodation fees less
50 UK pounds administration costs is payable for cancellations received,
in writing, before 1st May 1999. After this time no fees are returnable.
However, substitutions may be made at any time.
The organisers reserve the right to make alterations to the stated programme
and other arrangements as deemed necessary.
If the conference is cancelled by the organisers, registered
delegates will be given as much notice as possible. However, our liability
will be limited to the refund of conference and accommodation fees without
deductions. All VAT is quoted at the rate of 17.5%. If the VAT rate is
amended by legislation, the Conference Organisers reserve the right to
amend the registration and accommodation fees accordingly. Drinks,
telephone charges, newspapers and additional meals (other than those
included in the conference fees) ordered by delegates staying at the
Holiday Inn will be charged to delegates placing such orders personally
and such additional items must be paid for in full, at hotel reception,
prior to departure.
CONFERENCE REGISTRATION FORM
Statistical Issues in Biopharmaceutical Environments :
Towards the New Millennium 28th - 30th July 1999
Please register the following delegate for the conference
(for multiple registrations please use copies of this form).
Title (Prof/Dr/Mr/Mrs etc) :
_______________________________________________
Last Name :
_______________________________________________
First Name(s) :
_______________________________________________
Position/Job Title :
_______________________________________________
Company/Organisation :
_______________________________________________
Address :
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__________________ Postcode____________________
Telephone :
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Fax :
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Email :
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Please tick appropriate items below to indicate your requirements.
CONFERENCE FEES
Please reserve a place at the Conference at the total cost
of 699.13 UK pounds inclusive of VAT
CONFERENCE ACCOMMODATION
Please reserve three nights bed and breakfast accommodation at the
Holiday Inn Leicester at the total cost of 223.25 UK pounds inclusive of VAT
Please reserve the following extra nights B & B accommodation at
the Holiday Inn at 76.38 UK pounds inclusive of VAT
No of nights :.....................................
Please specify day(s)/date(s) of any extra nights :
.....................................................................
Total cost of extra nights : ......................
ACCOMPANYING PARTNERS
Please reserve accommodation at the Holiday Inn for the accompanying
partner named below at 14.69 UK pounds per night :-
Name : ............................................
No of nights :.....................................
Please specify day(s)/date(s) :
.....................................................................
Total cost of accompanying partner : ..............
GUEST DINNER TICKETS
Please reserve GUEST place(s) at the Conference Dinner at 47.00 UK pounds inc VAT
Indicate number of GUEST tickets : ................
Please reserve GUEST place(s) at the Excursion Dinner at 55 UK pounds inc VAT
Indicate number of GUEST tickets : ................
Total cost of guest tickets : .....................
SPECIAL REQUIREMENTS
(Please indicate any special requirements relating to disability,
diet or food allergies etc)
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GRAND TOTAL OF CONFERENCE AND ACCOMMODATION FEES :
______________________________________ UK pounds inc VAT
PAYMENT DETAILS
Payment can be made by cheque, credit card or by payment of company invoice.
Please indicate below your chosen method of payment and provide the relevant
details.
Payment to be made by :-
CHEQUE made payable to De Montfort Expertise Ltd ?
CREDIT CARD
VISA/Mastercard
Access/Eurocard American Express ?
Card No. __________________________________________________
Expiry Date ________________________________________________
Name(as on card) ___________________________________________
Cardholder's address ______________________________________
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Cardholder's Signature_____________________________________
Date ______________________________________________________
INVOICE ?
Name and address of person to be invoiced :
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___________________________________________________________
___________________________________________________________
_______________________ Postcode______________________
CONDITIONS OF REGISTRATION ARE AS STATED ON THE CONFERENCE DETAILS ATTACHED
Please send this form, together with your remittance, to :-
Dr Briony A Teather
Executive Secretary SIBE'99 Conference
Department of Medical Statistics
Faculty of Computing Sciences and Engineering
De Montfort University
The Gateway
Leicester LE1 9BH England
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Dr Briony A Teather
Principal Lecturer in Medical Statistics
Executive Conference and Short Course Secretary
Department of Medical Statistics Tel : +44 (0)116 2577480
De Montfort University Fax : +44 (0)116 2506114
The Gateway Email : [log in to unmask]
Leicester LE1 9BH
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