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www.smi-online.co.uk/adaptive-designs.asp
Register online and receive full information on all of SMi’s conferences
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
GROUP DISCOUNTS AVAILABLE
SMi MASTERCLASS SERIES 2014
SMi Training Presents....
Adaptive Designs: Concepts
and Practical Considerations
for Implementation
Hosted By: Pantelis Vlachos, Director of Strategic Consulting, Cytel
Overview:
As clinical development teams are working in an increasingly pressured and complex environment,
they are looking toward different types of trial designs to address their development challenges. This
course will present key concepts in clinical trial designs, different types of design options (with a focus
on adaptive designs), and their benefits as well as possible complexities. The trainer will employ East
software as a design interface, demonstrating how the clinical team can visualize and evaluate the
key operating characteristics of a design. Wherever possible, case examples from recent clinical
trials will be used to help illustrate concepts and real-world application of the designs.
Why you should attend this Masterclass:
This workshop is intended for medical officers, biostatisticians, and core members of the clinical team
who would like to better understand the range of trial designs available to them, and which are
accepted by regulators. It will enable them to look beyond off-the-shelf designs and to consider
options which would allow for patient savings, built-in flexibility, improved knowledge-return from a
study, and an earlier time-to-market. The workshop will also inform the participants about methods
they can use to better forecast the outcomes of a trial, and monitoring tools that can help them
plan or adjust to trial changes.
MC 402
2014
2nd
Central London
DEC
www.smi-online.co.uk/adaptive-designs.asp
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
GROUP DISCOUNTS AVAILABLE
Adaptive Designs: Concepts and Practical
Considerations for Implementation
8.30 Registration and Coffee
9.00 Introduction to East Trial Design
(Including Workshop)
10.30 Morning Coffee
10.45 Group Sequential Designs
(Including Workshop II)
12.30 Networking Lunch
13.00 Group sequential designs
(Workshop Continued)
13.30 Adaptive Designs
14.30 Afternoon Tea
14.45 Adaptive Designs
(Including Workshop III)
15.45 Further Features of East
16.00 End of Masterclass
FULL DAY PROGRAMME
About your masterclass leader:
Pantelis is a Director of Strategic Consulting for Cytel, Inc. based in Geneva. He joined the company in January
2013. Before that, he was a Principal Biostatistician at Merck Serono as well as a Professor of Statistics at Carnegie
Mellon University for 12 years. His research interests lie in the area of adaptive designs, mainly from a Bayesian
perspective, as well as hierarchical model testing and checking although his secret passion is Text Mining. He is
the Managing Editor of the journal “Bayesian Analysis” and has served in the editorial boards of several other
journals and online statistical data and software archives.
About the Organisation:
Cytel offers a broad range of high-quality, flexible and cost-effective solutions to support
all phases of drug, biologic and device development. We provide our customers with
unrivaled knowledge in biostatistics and operations research for software development,
strategic consulting and clinical research services. We combined this knowledge with our trial implementation
capabilities, to help our customers uphold the highest standards of scientific rigor, statistical validity, and data
quality in all of our engagements.
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
ADAPTIVE DESIGNS: CONCEPTS AND PRACTICAL
CONSIDERATIONS FOR IMPLEMENTATION
Tuesday 2nd December 2014, Central London
4 WAYS TO REGISTER
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
www.smi-online.co.uk/adaptive-designs.asp
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit card details will be requested and payment taken before entry to the event. Bookings within
7 days of an event require payment on booking.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing
that cancellation is made in writing and received at least 28 days prior to the start of the event.
Regretfully cancellation after this time cannot be accepted.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about
other products and services. Unless you tick here □ we may also share your data with third parties
offering complementary products or services. If you have any queries or want to update any of
the data that we hold then please contact our Database Manager databasemanager@smi-
online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above
your address on the attached letter.
Unique Reference Number
Our Reference LV MC402
Terms and Conditions of Booking
DELEGATE DETAILS
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi's Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference MC402 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment
are below. Please indicate method of payment.
□ UK BACS Sort Code 300009, Account 00936418
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 00936418
IBAN GB48 LOYD 3000 0900 9364 18
□ Cheque We can only accept Sterling cheques drawn on a UK bank.
□ Credit Card □ Visa □ MasterCard □ American Express
All credit card payments will be subject to standard credit card charges.
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Valid From □□/□□ Expiry Date □□/□□
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Cardholder’s Name:
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I agree to be bound by SMi's Terms and Conditions of Booking.
Card Billing Address (If different from above):
PAYMENT
VENUE Central London
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712
FUTURE MASTERCLASSES
I would be interested in attending a Masterclass on the following topic or area:
MASTERCLASS PRICE
I would like to attend: (Please tick) Price Total
MASTERCLASS FEE
Ⅺ Masterclass £599.00 + VAT £718.80
VAT
VAT at 20% is charged on the attendance fees for all delegates.

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Adaptive designs - concepts and practical considerations for implementation

  • 1. www.smi-online.co.uk/adaptive-designs.asp Register online and receive full information on all of SMi’s conferences Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 GROUP DISCOUNTS AVAILABLE SMi MASTERCLASS SERIES 2014 SMi Training Presents.... Adaptive Designs: Concepts and Practical Considerations for Implementation Hosted By: Pantelis Vlachos, Director of Strategic Consulting, Cytel Overview: As clinical development teams are working in an increasingly pressured and complex environment, they are looking toward different types of trial designs to address their development challenges. This course will present key concepts in clinical trial designs, different types of design options (with a focus on adaptive designs), and their benefits as well as possible complexities. The trainer will employ East software as a design interface, demonstrating how the clinical team can visualize and evaluate the key operating characteristics of a design. Wherever possible, case examples from recent clinical trials will be used to help illustrate concepts and real-world application of the designs. Why you should attend this Masterclass: This workshop is intended for medical officers, biostatisticians, and core members of the clinical team who would like to better understand the range of trial designs available to them, and which are accepted by regulators. It will enable them to look beyond off-the-shelf designs and to consider options which would allow for patient savings, built-in flexibility, improved knowledge-return from a study, and an earlier time-to-market. The workshop will also inform the participants about methods they can use to better forecast the outcomes of a trial, and monitoring tools that can help them plan or adjust to trial changes. MC 402 2014 2nd Central London DEC
  • 2. www.smi-online.co.uk/adaptive-designs.asp Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 GROUP DISCOUNTS AVAILABLE Adaptive Designs: Concepts and Practical Considerations for Implementation 8.30 Registration and Coffee 9.00 Introduction to East Trial Design (Including Workshop) 10.30 Morning Coffee 10.45 Group Sequential Designs (Including Workshop II) 12.30 Networking Lunch 13.00 Group sequential designs (Workshop Continued) 13.30 Adaptive Designs 14.30 Afternoon Tea 14.45 Adaptive Designs (Including Workshop III) 15.45 Further Features of East 16.00 End of Masterclass FULL DAY PROGRAMME About your masterclass leader: Pantelis is a Director of Strategic Consulting for Cytel, Inc. based in Geneva. He joined the company in January 2013. Before that, he was a Principal Biostatistician at Merck Serono as well as a Professor of Statistics at Carnegie Mellon University for 12 years. His research interests lie in the area of adaptive designs, mainly from a Bayesian perspective, as well as hierarchical model testing and checking although his secret passion is Text Mining. He is the Managing Editor of the journal “Bayesian Analysis” and has served in the editorial boards of several other journals and online statistical data and software archives. About the Organisation: Cytel offers a broad range of high-quality, flexible and cost-effective solutions to support all phases of drug, biologic and device development. We provide our customers with unrivaled knowledge in biostatistics and operations research for software development, strategic consulting and clinical research services. We combined this knowledge with our trial implementation capabilities, to help our customers uphold the highest standards of scientific rigor, statistical validity, and data quality in all of our engagements.
  • 3. If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk ADAPTIVE DESIGNS: CONCEPTS AND PRACTICAL CONSIDERATIONS FOR IMPLEMENTATION Tuesday 2nd December 2014, Central London 4 WAYS TO REGISTER POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK www.smi-online.co.uk/adaptive-designs.asp FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of an event require payment on booking. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □ we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi- online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. Unique Reference Number Our Reference LV MC402 Terms and Conditions of Booking DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference MC402 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment. □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): PAYMENT VENUE Central London □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 FUTURE MASTERCLASSES I would be interested in attending a Masterclass on the following topic or area: MASTERCLASS PRICE I would like to attend: (Please tick) Price Total MASTERCLASS FEE Ⅺ Masterclass £599.00 + VAT £718.80 VAT VAT at 20% is charged on the attendance fees for all delegates.