The course focuses on an introduction to PK and an explanation of the classical methodologies of PK/PD studies. It examines the relevance of PK/PD studies on various phases of drug development, how this data can be used more effectively in the go/no go decision and designing later stage clinical trials protocols. The regulatory aspects of PK are discussed in some detail.

Who Will Attend? This course is aimed at anyone who comes in to contact with PK/PD data but does not require specialist knowledge in the field. No previous knowledge of PK/PD is assumed. The course is designed to give an overview of the field without the equations. It will be of particular benefit to professionals working in: Development, Preclinical, Phase I, Clinical Operations, Regulatory Affairs, Data Management, Drug Safety, Clinical Pharmacology, Registration, Licensing.

Course Leader: Chris Ward BSc (Hons), Director, Pharmacometrics, Covance

For the past 7 years, Chris has held the position of Director of the Covance CRU Pharmacometrics Division, a group of over 70 scientists involved in the data management, analysis and reporting of safety, efficacy, PK and PD data from a wide range of Phase I and proof of concept studies in patients. Under Chris’s leadership the emphasis of the Pharmacometrics group is the effective design and efficient reporting of Clinical Pharmacology studies ranging from early safety studies through to Phase IIa trials.

Registration required:

Yes

Free:

No