Dr. Andrea Weiland-Waibel is a managing director of Explicat® Pharma GmbH, a privately- owned company, providing technical project management services and pharmaceutical development services to the pharmaceutical industry (CMC). Andrea is a pharmacist with a PhD in pharmaceutical technology on biodegradable microspheres and cyclodextrins (Ludwig Maximilian University, Munich). She held several leading roles within Pfizer, working as project manager in process technology and being responsible for technology transfer and process development, mainly on sustained release solid dosage forms. Within R&D she was a responsible scientist for pharmaceutical development (Phase I - III, candidate characterisation, and lyophilisation projects). After joining IDEA AG, a biotechnology company based in Munich, Andrea held the position of director of pharmaceutical development and was responsible for process technology development, drug delivery system development (liposomes, patches), formulation of recombinant proteins, analytical development and clinical supplies manufacturing. She also served as IDEA`s QP and is the founder of Explicat Pharma GmbH and has been the managing director since 2005. She and her team`s experience cover the development of biopharmaceuticals (e.g. recombinant factor VIII), development of lyoformulations and lyocycles, analytical development, related QA and regulatory issues. Explicat Pharma has been assigned several projects, involving the modern process validation approach, including lyocycle robustness testing. Andrea is a qualified individual and a member of AAPS and several other professional institutions, based in Europe, including APV, DphG, Bay, LAK and A3P.