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Nov 10 2014 9:00AM - Nov 11 2014 4:00PM | Tryp Barcelona Apolo
Avinguda del Parallel, 57-59
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).
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.
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.
DIA has blocked a limited number of rooms at the following hotel:
TRYP Barcelona Apolo HotelAvinguda del Paral·lel, 57-59,08004, Barcelona, Spain Tel: (34) 93 343 30 00Fax: (34) 93 443 0059E-mail: email@example.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.
Registration QuestionsPhone.: +41 61 225 51 51 Fax: +41 61 225 51 52 Monday-Friday 8:00-17:00 CETdiaeurope@diaeurope.org
Agenda and Event LogisticsMagdalena Lewandowska, Event ManagerPhone: +41 61 225 51 65Fax: +41 61 225 51 firstname.lastname@example.org
Global Head Full Development Biostatistics OncologyNovartis Pharma AG, Switzerland
Expert StatisticianAlmirall, Spain
Scientific Director, Biostatistics and DataClinic Hospital of Barcelona, Spain
Head of Biostatistics and Special PharmacokineticsFederal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Director of BiostatisticsF. Hoffmann-La Roche Ltd., Switzerland
Chair of Department of Medical StatisticsGeorg-August-University Goettingen, Germany
Executive Director BiostatisticsMSD Europe, Inc., Belgium
Professor of BiostatisticsCatholic University of Leuven, Belgium
LACK OF ADHERENCE AND THE CHOICE OF THE RIGHT ESTIMAND IN CLINICAL TRIALS
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.
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.
KEY TOPICS IN REGULATORY STATISTICS