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Joint DIA/AEMPS Statistics Workshop

Nov 10 2014 9:00AM - Nov 11 2014 4:00PM | Tryp Barcelona Apolo Avinguda del Parallel, 57-59 08004 Barcelona Spain

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Overview 

The last three annual conferences have been co-sponsored by the EMA, MHRA and BfArM. This year’s event - statistical methodology in clinical research and development - is a joint workshop with the AEMPS, the Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios).

Featured Topics 

  • Latest news on emerging regulatory guidance documents for clinical trial methodology
  • Clinical Trial Transparency – practical challenges ahead for statisticians
  • Harmonising sponsor and regulator decision-making across the life-cycle, from dose-finding through benefit-risk and beyond; understanding hurdles and optimising methods with a focus on Bayesian Statistics and quantitative Benefit Risk
  • Therapeutic area special; a focus on biological medicines
  • Clinical Practice Research Datalink tutorial
  • Incorporating real world data into drug development, licensing, re-imbursement and prescribing
  • Risk-based monitoring
  • Increasing the breadth of sponsor / regulator interactions on methodology

Who Should Attend 

Professionals with an interest in the application of, and research into, statistics in the drug development process from the pharmaceutical industry, academia, regulatory and governmental agencies, as well as contract research organisations.

Learning Objectives 

Defining the objective of a clinical trial in the presence of non-adherence to the assigned treatment is crucial for the choice of a proper statistical analysis and the interpretation of the results: the meeting will provide an insight on the different views on the choice of an appropriate estimand (i.e. on what is to be estimated) and the design options and analysis methods related to the selected estimand.

The methodological issues related to the assessment of biosimilarity of biological products for regulatory approval have recently received much attention due to the essential differences between biosimilars and small molecule generics. The meeting will focus on the statistical aspects of the different components in the development of a biosimilar that are required for marketing authorization.

The meeting further aims to illustrate how innovative methods can be used to identify subgroups that benefit in particular from a new treatment and how this knowledge can be integrated into clinical development plans through adaptive and enrichment designs to develop personalised / stratified treatment strategies. Discussions will consider not only the methods themselves, but also how to best implement them in a regulatory context.

Beyond this, the meeting will also serve as a forum for sharing an update on the latest EMA guidance documents and activities, including recent positive opinions.

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

TRYP Barcelona Apolo Hotel
Avinguda del Paral·lel, 57-59,
08004, Barcelona, Spain
Tel: (34) 93 343 30 00
Fax: (34) 93 443 0059
E-mail: tryp.apolo@melia.com
 
at the rate of:
EUR 85.00 single use
incl. of breakfast, excl. of VAT and city tax

To make your reservation, please click here: http://meetings.melia.com/en/DIAEUROPE.html

Important: The room rate is available until 04 October 2014 or until the group block is sold-out, whichever comes first.
In case of no-shows the hotel is authorised to charge the full amount corresponding to the duration of your stay.

Contact Information 

Registration Questions
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Magdalena Lewandowska, Event Manager
Phone: +41 61 225 51 65
Fax: +41 61 225 51 52
magdalena.lewandowska@diaeurope.org

Program Committee 

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Agenda  

Day 1 Monday, Nov 10, 2014

  • 12:30PM - 2:00PM

    REGISTRATION AND WELCOME COFFEE
  • 2:00PM - 3:30PM

    LACK OF ADHERENCE AND THE CHOICE OF THE RIGHT ESTIMAND IN CLINICAL TRIALS


    Session Chair(s):

    • Norbert Benda, PhD
      Head of Biostatistics and Special Pharmacokinetics
      Federal Institute For Drugs and Medical Devices (BfArM), Germany
    • William Malbecq, DrSc
      Executive Director Biostatistics
      MSD Europe, Inc., Belgium

    LACK OF ADHERENCE AND THE CHOICE OF THE RIGHT ESTIMAND IN CLINICAL TRIALS

    Speaker(s):

    • Mouna Akacha
      Statistical Methodologist
      Novartis Pharma AG, Switzerland
  • 3:30PM - 4:00PM

    COFFEE BREAK
  • 4:00PM - 5:30PM

    LACK OF ADHERENCE AND THE CHOICE OF THE RIGHT ESTIMAND IN CLINICAL TRIALS

    Speaker(s):

    • Ann-Kristin Leuchs
      Statistician
      Bfarm, Germany

Day 2 Tuesday, Nov 11, 2014

  • 9:00AM - 10:30AM

    STATISTICAL APPROACHES IN BIOSIMILARITY


    Session Chair(s):

    • Beatriz Seoane Núñez
      Expert Statistician
      Almirall, Spain
    • Ferran Torres, PhD
      Scientific Director, Biostatistics and Data
      Clinic Hospital of Barcelona, Spain

    A Biosimilar medicine is a growing field. The number of regulatory applications has increased in recent years. This session will highlight the features of the study design options for biosimilar efficacy trials. The choice of margins, their reliability and the different statistical and regulatory considerations associated with them will be some of the topics that will be discussed in this session from both a regulatory and industry point of view.

    Speaker(s):

    • STATISTICAL APPROACHES IN BIOSIMILARITY
      Peter Volkers
      Biostatistician
      Paul Ehrlich Institute, Germany
    • Yulan Li
      Biostatistician
      Novartis, United States
  • 10:30AM - 11:00AM

    COFFEE BREAK
  • 11:00AM - 12:30PM

    HOW PRECISE CAN PRECISION MEDICINE BE?


    Session Chair(s):

    • Hans-Ulrich Burger
      Senior Director of Biostatistics
      F. Hoffmann-La Roche Ltd., Switzerland
    • Tim Friede, PhD
      Chair of Department of Medical Statistics
      Georg-August-University Goettingen, Germany

    Precision medicine becomes more and more important in drug development. Among the many topics possible we picked out two, biomarker identification and seamless enrichment designs. There will be a short introduction into the topic, an overview and different methods, then two examples from industry and a regulatory evaluation. Finally the two sessions will be rounded up by a panel discussion.

    Speaker(s):

    • Tim Friede, PhD
      Chair of Department of Medical Statistics
      Georg-August-University Goettingen, Germany
    • Kaspar Rufibach
      Biostatistician, Oncology Biostatistics
      F. Hoffmann-La Roche AG, Switzerland
    • Heinz Schmidli, PhD, MSc
      Senior Expert Statistical Methodologist
      Novartis Pharma AG, Switzerland
  • 12:30PM - 2:00PM

    LUNCH
  • 2:00PM - 3:30PM

    HOW PRECISE CAN PRECISION MEDICINE BE?


    Session Chair(s):

    • Norbert Benda, PhD
      Head of Biostatistics and Special Pharmacokinetics
      Federal Institute For Drugs and Medical Devices (BfArM), Germany
    • Hans-Ulrich Burger
      Senior Director of Biostatistics
      F. Hoffmann-La Roche Ltd., Switzerland
    • Tim Friede, PhD
      Chair of Department of Medical Statistics
      Georg-August-University Goettingen, Germany

    Speaker(s):

    • Hans-Ulrich Burger
      Senior Director of Biostatistics
      F. Hoffmann-La Roche Ltd., Switzerland
  • 3:30PM - 4:00PM

    COFFEE BREAK
  • 4:00PM - 4:00PM

    KEY TOPICS IN REGULATORY STATISTICS


    Session Chair(s):

    • Hans-Ulrich Burger
      Senior Director of Biostatistics
      F. Hoffmann-La Roche Ltd., Switzerland

    KEY TOPICS IN REGULATORY STATISTICS

    Speaker(s):

    • Andrew Peter Grieve, DrSc, PhD, MSc
      Senior Vice President Clinical Trial Methodology
      Aptiv Solutions, Germany

Registration Fees 

Other Fees

Student
€200.00

Member

Member Academia
€710.00
Member Government
€710.00
Member Standard
€1220.00
Member Standard (As of 09/29/2014)
€1420.00

Non-Member

NonMember Academia
€840.00
NonMember Government
€840.00
NonMember Standard
€1550.00
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