Program Overview

Professional Education

Study

Non-clinical and Early Clinical Development (7MCS0010)

Course Overview

This module provides training over five days on the principles and practical application of chemistry, pharmacology, toxicology, and pharmacy to the discovery and development of new medicines using sound study protocols, monitoring strategies, and data gathering techniques in early clinical trials, including non-patient volunteer studies. The pharmacology element includes the basic principles, plus the use of animal models, including transgenic models.

Course Features

Students will see how pharmacology studies inform the choice of drug candidates and will learn the importance of pre-clinical safety testing, including what tests are needed to start and progress a clinical development programme. Students will learn about the regulatory requirements for toxicology studies and how to look for critical information within a toxicology report. The module will also introduce aspects of pharmaceutical sciences, including the choice of formulation, stability testing, scale-up, and how these issues can impact on a clinical trial programme. Students will understand how early, clinical pharmacology, studies can be designed to inform later phase therapeutic studies and contribute to dosing recommendation of marketed medicines.

Course Content

The aim of this module:

• Is to introduce students to the main areas of pre-clinical science and early clinical development so that they will be better able to contribute to a product development plan and appreciate how the knowledge obtained can inform therapeutic clinical trial design and a risk management plan.
• Students will be given instruction in the principles and application of pharmacology, toxicology, pharmacy, and clinical pharmacology as they apply to the discovery and development of new medicines.
• Students will have problems to solve during the project that will enable them to think about the lessons they have learned and work through complex obstacles.

Learning Outcomes

By the end of the module, the students should be able to:

• Design a dosage form and a pharmaceutical development process that is appropriate to meet the demands of chemical, pharmaceutical, pharmacological, and clinical development needs of a medicine for a given clinical need.
• Evaluate the elements of a pre-clinical toxicology plan and justify their appropriateness in terms of the pharmacological, pharmaceutical, regulatory, and clinical requirements of medicines development.
• Critically appraise how pre-clinical pharmacokinetic and pharmacodynamic data can support the progress of a medicine into human clinical trials.
• Be able to critically review a clinical pharmacology Phase 1 plan.

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 pharmacology, toxicology, pharmacy, and clinical pharmacology as they apply to medicine development industry e.g. pharmaceutical physicians, scientists in R&D and medical affairs, and regulatory affairs personnel.

Key Information

• Course code: 7MCS0010
• Credit level: 7
• Credit value: 15
• Duration: 5 days
• Fees & Discounts:
  • Full Price: £1,412.00
  • International: £3,975.00

Offered by

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