Karen (griffith) Hue BSc, FRQA

Karen graduated with a B.Sc. in Applied Biology specialising in pharmacology followed later on with a diploma in total quality management. Her career started in toxicology in preclinical research followed by a short spell working in transplantation in Addenbrooke’s and Papworth Hospitals in Cambridge where she ran an investigator-led clinical trial focussing on population pharmacokinetics on a popular anti-rejection therapy. In 1991 she made the move to SmithKline Beecham in the Regulatory Compliance department and covered all types of auditing in clinical trials, including working on one of the first eCRFs. This led to a move to ADAMAS consulting and time spent covering auditing, inspections and gap analysis for many clients including CSV and of course the year 2000 projects.

During this time Karen was a member of the RQA professional teaching team on the CSV courses and is a Fellow in RQA (FRQA). After leaving ADAMAS Karen became a consultant again focussing on CSV activities, inspection readiness and hosting as well as many gap analysis. In 2013 she went back to full-time employment in Optum Lifesciences and worked in the late phase and health economics area. After Optum Lifesciences was acquired by Mapi, Karen moved to Intercept Pharmaceuticals, a biotech company specialising in liver disease and then to Aimmune Therapeutics Inc, a company developing treatments for food allergies using biologic product candidates and a characterized oral desensitization immunotherapy (CODIT™) approach. During her career to date, she has been involved in inspections from the FDA, Health Canada, the MHRA, Health Products Regulatory Authority (formerly the Irish Medicines Board) and the EMA, both for GCP and GvPV.