Program Overview

Advanced Clinical Pharmacology (7BBM0006)

Course Overview

This module provides advanced training over five days in the principles of clinical pharmacology essential to drug development. This includes practical and ethical issues associated with non-patient volunteer studies, the design of such studies and interpretation of the results. Completion of this module will enable you to take an active role in a multidisciplinary team to design and analyse clinical pharmacology studies.

Course Details

• Duration: 5 days
• Fees:
  • Full Price: £1,412.00
  • International: £3,975.00
• Credit Level: 7
• Credit Value: 15
• Course Code: 7BBM0006

Course Features

Key topics include: Non-patient volunteer studies, planning a clinical development strategy, use of pharmacodynamic and pharmacokinetic measures in clinical pharmacology studies, statistical principles used in clinical pharmacology studies. You will take part in practical sessions to plan a clinical development strategy for a potential new medicine, prepare a study protocol, analyse study results and learn how to present clinical pharmacology study results through both verbal and written presentations.

Course Content

• Provides advanced training in the principles of clinical pharmacology that are utilised in the process of drug development.
• Gives students an in-depth understanding of practical issues associated with non-patient volunteer studies according to current regulatory guidelines.
• Instils an in-depth understanding of how to generate sound study protocols, effective monitoring strategies and data gathering techniques for non-patient volunteer studies.
• Gives an in-depth understanding of the most significant areas of pharmacokinetic and pharmacodynamic data gathering, processing and interpretation.
• Enables students to develop a clear, articulate and unbiased approach to the interpretation and assessment of pharmacokinetic and pharmacodynamic data generated in clinical pharmacology studies.
• Enables students to develop methods to effectively disseminate clinical pharmacology study results through both verbal presentations and the generation of written reports.

Learning Outcomes

By the end of this module students will be able to:

• Take an active role in a multidisciplinary team to design clinical pharmacology studies.
• Recognise the particular ethical issues of using non-patient volunteers in clinical studies.
• Understand and interpret both pharmacodynamic and pharmacokinetic data.
• To understand and interpret the safety data arising in a clinical pharmacology study.
• Gain a working knowledge of the statistical principles used in clinical pharmacology studies.
• Be able to critically review a clinical pharmacology paper.
• To be able to discuss how data from a clinical pharmacology study can inform the future development of a medicine.

Entry Requirements

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject. The course will suit individuals seeking to develop a practical understanding of clinical pharmacology in the pharmaceutical industry e.g. pharmaceutical physicians, scientists in R&D and medical affairs, and regulatory affairs personnel.

Offered By

Faculty of Life Sciences & Medicine Institute of Pharmaceutical Science Centre for Pharmaceutical Medicine