Validating assessments

She has also undertaken an extensive study of public policy and carcinogenic risk assessment of pharmaceuticals.

The first method uses the median error rate, and the second method is a Bayesian estimator of the error rate based on the observed errors and the number of observations.Helen worked for 20 years as a senior medical statistician in the University of Oxford, collaborating with researchers and clinicians in a variety of other specialties, most notably in orthopaedics, where she worked on the development and validation of a number of PROs.Helen was educated first at Warwick University where she took a BSc degree in Biological Sciences (1984) and then at Oxford University where she received a post-graduate diploma in Applied Statistics (1986), an MSc in Clinical Medicine by research (1992) and a DPhil in Clinical Medicine (2005).We will also reflect on the value of FDA Guidance on the use of PRO measures (FDA/SEALD Guidance for Industry 2009) for Perf Os, and review the FDA Clinical Outcome Assessment Compendium and other sources for indication of the extent and nature of use of Perf Os to support labelling claims in conditions more widely.The objectives of this webinar are to: Nicki has been with Eli Lilly and Company’s Global Patient Outcomes and Real World Evidence (GPORWE) group for five years.Although not entirely new, use of these types of technologies is gaining momentum and senior decision makers need to be aware of the potential of this growth area and also the issues and challenges.

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