Susan Bairnsfather entered the pharmaceutical industry
22 years ago with degrees in pre-medicine (human biology
and biochemistry majors) and computer science, and a
postgraduate qualification in pharmacology from
Louisiana State University Medical Center. She worked
at Boots Pharmaceuticals for 7 years as a regulatory
associate, 10 years as a statistical programmer, and 2
years as a regulatory writer for CROs before establishing
her own company, EPharmaTech, in 2006. She now pro-
vides consultancy services as a regulatory writer, regu-
latory publisher, and statistical programmer. Susan has
wide experience in writing the full range of preclinical and
clinical regulatory documents, including submissions for the
US, Canadian, and EU authorities. She is also experienced
in data analyses and in electronically integrating documen-
tation to the eCTD. She has been active as a member, pre-
senter, and work shop leader for AMWA, EMWA, DIA, and
the Pharmaceutical SAS Users Group (PSUG). She has add-
itionally participated in CDISC and in HL7 SPL initiatives..
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