Biography:
Hannah is currently Regional Manager of Global Quality and Compliance (GQC) for GlaxoSmithKline (GSK). She has worked for GSK for more than 14 years, including 9 years in the area of clinical compliance. She has also spent approximately 6 years in Clinical Research.
Within her time working in GQC, Hannah is responsible for conducting internal audits and coordinating regulatory inspections. She has conducted a variety of GCP audits in majority of Asian Pacific countries, as well as in African and European countries. Hannah was also involved in a number of pharmacovigilance system audits in the GSK headquarters in the US, UK and Belgium. She hosted a number of regulatory inspections at investigator sites conducted by US FDA, EMA, Korea FDA and Chinese SFDA. She has also been involved in internal and external training programs, also involved as training assistant during GCP inspection training provided by US FDA to SFDA inspectors during 2010 – 2011. Hannah has been working closely with SFDA in drafting GCP guidance documents including Guidance Document on Investigator Site Management, Guidance Document for Phase I Unit and Guidance Document for Sponsor.
Hannah obtained her Medical Degree from Capital University of Medical Sciences in China and worked as a Pediatrician in Beijing Children’s Hospital for 10 years before joined industry in 1996.