The aim of the course is to increase the participants’ knowledge and understanding of the EMA regulatory demands and guidelines concerning the clinical pharmacology and pharmacokinetic aspects of the drug development process. A brief introduction to the recommended standard clinical pharmacology and pharmacokinetics study package will continue into an overview of in silico, in vitro and in vivoapproachesto elucidate the pharmacokinetics of an investigational drug. Different regulatory guidelines and their recommendations will be presented and discussed. The course will also describe specific clinical pharmacology studies and their importance for the characterization and the efficacy and safety aspects of the investigational drug. Further, the importance of clinical pharmacology data to assure suitable product information of a new drug will be discussed. In addition, regulatory aspects of bioequivalence and development of generic drugs will be presented.
Regulatory Aspects of Clinical Pharmacology
This course will be of value to anyone working in drug discovery and development within academy, industry and contract research organizations. The focus of the course will be on the regulatory aspects of clinical pharmacology an pharmacokinetics in Europe.
