以下公司骨干的介绍为英文:

M.Sc. Director Regulatory Affairs

In September 2000, Patricia Baede-van Dijk, M.Sc. joined Kinesis Pharma B.V. as Senior Consultant Regulatory Affairs and Project Manager Clinical Pharmacokinetics. From July 2006 onwards, she is appointed as Director Regulatory Affairs. In this position, she consults on regulatory affairs within drug development to Sponsors and to drug development projects within Kinesis Pharma. She prepared more than 50 regulatory documents, including clinical expert reports and overviews, for various types of applications.

Having over 14 years experience in preclinical and clinical pharmacokinetic research, her previous function as Project Manager Clinical Pharmacokinetics covered a broad range of pharmacokinetic activities. She participated in clinical drug development teams, being responsible for the design and coordination of Phase I studies, including preparation of Clinical Trial Protocols. She supervised pharmacokinetic analysis and reporting within clinical trials, partly as Study Director according to GLP-guidelines. Overall, she participated in more than 75 clinical trials. In addition, she carries out toxicological risk assessments for chemicals, pharmaceutical excipients and medical devices and predicts toxicokinetic behaviour for the environmental risk assessments of chemicals.

Previous to joining Kinesis, she worked for 6 years as Clinical Pharmacokinetic Reviewer for the Dutch Medicines Evaluation Board and the EMEA, giving her extensive knowledge on Regulatory Procedures and Guidelines. A substantial part of her publications were aimed at making physicians in The Netherlands aware of the drug-drug interaction concepts. During her time at the Medicines Evaluation Board, she participated in a research project on pharmacokinetics and interactions of antiretroviral agents at the Department of Clinical Pharmacy, University Medical Centre Nijmegen, The Netherlands.