Dr Day has a particular interest, and wide experience of working in the field of orphan products.

He was lead author for the CHMP Guidance document on Clinical Trials in Small Populations
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003615.pdf

He helped develop the FDA–NIH course on the Science of Small Clinical Trials
http://small-trials.keenminds.org/
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/ucm312575.htm
and has been a key presenter each year it has run.

He has successfully helped companies through regulatory approvals of several orphan products in the US and Europe.

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