Title: How I wish I had known THAT when I worked in industry!
Speaker: Denise Till, Medicines and Healthcare Products Regulatory Agency
Time: 11 March 2009, 2-3 pm
Place: Postgraduate Statistics Centre, Lancaster University
Abstract
After working for 18 years in the pharmaceutical industry as a
statistician, I had assumed that I had a clear understanding of the
regulatory requirements concerning the statistical aspects of an
application. Two years after moving to the Licensing Division of MHRA,
I realise how mistaken I was! In spite of the large number of guidelines
available to the statistician working in drug development, it is far
from clear what the regulatory statistician considers important when
assessing an application. The aim of this presentation is to consider a
number of issues (e.g. missing data, a single pivotal study,
non-inferiority and equivalence, interim analysis etc.) and using small
case studies explain the focus of the statistical assessment.
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To give us an idea of numbers attending, please register for the seminar
by going to http://www.maths.lancs.ac.uk/psc
or contacting Angela Mercer, Postgraduate Statistics Centre,
Department of Mathematics and Statistics, Fylde College, Lancaster
University, Lancaster LA1 4YF, UK.
Tel: +44 1524 593064 Fax: +44 1524 592681 email:
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