In July 2015, regulatory expert Patricia Baede joined QPS’ clinical development teams. With 20 years of experience in clinical trial conduct and all regulatory aspects of drug development, Baede adds EU regulatory support to the growing portfolio of clinical activities QPS provides. In the past, she has worked on drug development teams as Phase I Clinical Trial Expert and as Phase II and Phase III Regulatory Expert. Her experience covers a broad range of indications with innovative as well as generic and biosimilar compounds. Patricia began her career as a pharmacokinetic reviewer at the Inspectie voor de Gezondheidszorg-the Netherlands regulatory agency.
Regulatory affairs services now available to benefit QPS clients include, among others: strategic advice on regulatory pathways and possibilities, direct access to a contact person for EU regulatory authorities, organization and chairing of meetings with EU authorities, submissions, and convincing writing for all types of regulatory documentation.
Patricia welcomes the opportunity to work with QPS’ experienced teams, so she may continue applying her regulatory expertise within the clinical phase of drug development. She is eager to support QPS clients world-wide with developing and registering new types of medicines, improving the length or quality of life for patients, and facilitating use of new medications in a sustainable health care system.