>Tracy has over 33 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. 10 years as an MHRA, EU and WHO PQT GMP Inspector. Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy has expertise across most dosage forms, particularly sterile manufactured products produced aseptically, including supporting the drafting of the GMP Annex 1 update and presenting on this topic at PIC/S and other global regulatory events.