Objectives
-MSc Pharmaceutical Medicine -PGDip Drug Development Sciences -PGCert Clinical Research The programme is designed to meet the needs of those working (or intending to work) in the specialty of pharmaceutical medicine, or those who require a professional qualification pertinent to pharmaceutical medicine. It is suitable for those practising within the pharmaceutical industry, the related fields of commerce, licensing authorities, or the public health service. The programme is designed to: -Enable students to secure further recognition as pharmaceutical medicine specialists -Give a greater understanding of pharmaceutical medicine in the domain of healthcare -Provide evidence of specialisation, which is increasingly required under EU legislation -Demonstrate proficiency across the whole field of pharmaceutical medicine through a system of continuous assessment -The programme enables you to gain a wider perspective of pharmaceutical medicine, including the discovery, development, evaluation, registration, monitoring and marketing of medicines. It will improve your ability to evaluate various aspects of drug development processes, and you will acquire postgraduate training suitable for senior scientific or clinical posts within pharmaceutical medicine. The part-time and modular nature of the programme is well suited to busy people with additional work commitments, allowing a flexible rate of attendance (one to four modules per year).
Course description
Pharmaceutical Medicine Module overview
Programme Orientation and Principles of Drug Development
This module is an introductory overview of the drug development process 'from molecule to medicine' and the healthcare environment within which the pharmaceutical industry operates.
Pre-Clinical Discovery and Development of New Medicines
This module considers the early stages in the drug development process, from research strategy to lead candidate identification, including the methodology used in establishing the toxicological profile of new drug candidates and predicting drug safety in man.
Regulatory Affairs*
This module covers the systems adopted by government authorities for regulating safety, efficacy and quality of medicines during the development and marketing of new drugs.
Clinical Pharmacology*
This module looks at the principles of clinical pharmacology and how they are applied in clinical studies.
Clinical Development and Therapeutics*
This module considers the principles of clinical research in clinical trial design, implementation, evaluation and reporting on Phase II-IV studies across many therapeutic areas.
Healthcare Marketplace
This module looks at the healthcare environment in which the commercial development of drugs takes place including strategic, financial and operational planning, marketing, sales and promotion.
Drug Safety
This module considers all aspects of safety monitoring, signal detection, study design, appraisal of safety issues, crisis management and communication.
Pharmacokinetics and Drug Absorption, Distribution, Metabolism and Excretion
This module covers pharmacokinetic analysis from sample collection through mathematical data analysis to interpretation of results. Factors affecting absorption, distribution, metabolism and excretion of a drug and their assessment in animals and man are looked at.
Clinical Pharmacology and Non-Patient Volunteer Study Design
This module considers the types of clinical pharmacology study and their implementation, and the legal, ethical, moral and regulatory requirements of study design in healthy human volunteer subjects.
Ethical and Legal Aspects
This module looks at the legal and ethical requirements for conduct of clinical research with an emphasis on regulatory control.
Translational Medicine and Biomarkers
This module explores the non-invasive methods used in healthy volunteers in decision making, the design of efficacy and safety studies in patients, and how these findings can be translated into the drug development programme.
Pharmacoeconomics
This module considers the key concepts underpinning pharmacoeconomic evaluations at different stages in the drug development process.
Research Methods
This module covers the practical approaches to understanding and conducting research in the pharmaceutical sector including study design, methodology and evaluation, including statistical principles and reporting.
* Modules validated by the Faculty of Pharmaceutical Medicine for Specialist Training purposes
Typical entry requirements
A degree (medical or non-medical) or professional qualifications and/or practical experience sufficient to satisfy the Head of Department and the Programme Directors of the applicant's ability to pursue the programme of study.
Selection is based upon the candidate's application and references. An informal interview may be required.
Programme length
4-8 modules over 24-72 months part-time/distance learning
