You might choose to complete one or two modules as part of your continuing professional development.
Alternatively, completion of four modules leads to award of a Postgraduate Certificate and completion of eight modules to award of a Postgraduate Diploma in:
These short courses offer flexible postgraduate training and may be appropriate if:
- you are only interested in selected modules
- you do not have time at present to undertake the full MSc programme
The modules are self-contained units taught over four or five days, and assessed independently.
ADME, Pharmacokinetics & Pharmacodynamics
Biological & Advanced Therapies
During this module, students will gain a comprehensive understanding of the principles of pharmacokinetics and pharmacokinetic/pharmacodynamic relationships and will learn how to apply these principles to predict the importance of demographic factors, drug-disease interactions, drug-drug interactions with modelling of PK/PD of specific drugs based on data provided.
Pharmacokinetic analysis from sample collection through data analysis to the interpretation of results will be considered as well as factors affecting absorption, distribution, metabolism and excretion of a drug.
Advanced Clinical Pharmacology
This module provides advanced training in the area of medicines produced by biotechnology. Participants will gain an in depth understanding on how to develop prophylactic vaccines and the differences between these and therapeutic vaccines. Participants will study the new therapeutic technologies that are in development as well as the ethical and regulatory frameworks that apply to these products. The differences between the clinical development programmes required by these different technologies will also be explored.
Clinical Drug Development
Over four days this module provides advanced training 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.
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.
Drug Development Pharmacology
This module covers the development of a new medicine from early exploratory clinical development right through to the stage of applying for a licence for marketing. We will highlight practical issues associated with running clinical trials, including large-scale multinational projects.
Key topics include: Clinical trial design, clinical end points, writing a protocol, project management, ethical and legal aspects of clinical research, logistics issues in clinical trials, clinical trials in children, data gathering for phase 2-4 studies, adverse events in clinical trials.
You will take part in workshop sessions and practical exercises to “develop” a new molecule and learn how to apply the principles of statistics to clinical trial design.
Drug Development Statistics & Data Management
This module covers the fundamental principles of pharmacology and how pharmacological concepts are applied in the context of pharmaceutical sciences. It will explore the role of pharmacology in the drug discovery/development process.
Key topics include: fundamental principles of pharmacology, such as dose-response relationship, benefit:risk ratio, agonism and antagonism, targets for drug action, in vitro techniques for assessing drug action, and pharmacokinetics/pharmacodynamics. There will be sessions on drugs and the cardiovascular system, drugs and blood, anti-infective drugs, drugs and cancer, and immunopharmacology.
Drug Regulatory Affairs
This module aims to provide a broad understanding of statistics as they apply to medicines development, including those used in clinical trials, to enable a power calculation to be done, to organise clinical trial data and to analyse and report the data. In addition methods used in drug safety studies including epidemiological approaches and meta analysis will be taught.
The module will consist of classroom teaching with a large element of practical experience designing studies and evaluating, analysing and presenting data.
Drug Safety & Ethics
This module explores the principles that underpin drug regulation in the UK and worldwide. Over four days, we will consider the regulatory requirements for special patient populations, commercial issues from product life cycle development through to marketing, pharmacovigilance, and the handling of off label and unlicensed medicines.
Key topics include: European regulatory procedures, ethics committees, adverse drug reaction reporting, regulatory requirements in special populations (eg, children, the elderly), advertising, internet sales, medical aspects of the Marketing Authorisation, bioequivalence and generics, special licensing issues (such as for biologicals, devices, herbal and homoeopathic medicines), and pharmacovigilance (pre- and post-marketing)
You will take part in a series of workshops to learn about practical aspects of Clinical Trial Authorisations, preparation of Summaries of Product Characteristics and Patient information leaflets, risk minimisation, and reclassification of the legal status of medicines.
Exploratory Drug Development
In this module, two of the most important issues within the drug development process and the whole of clinical research are addressed.
In addition to reviewing the general principles of medical ethics and how they apply to clinical research as defined within the various guidelines and statutes we will have presentations from patient groups and a member of an ethics committee. The issues around business ethics and marketing will also be explored.
We will look at the mechanisms of cellular toxicology, the value of spontaneous reporting and the use of large electronic data bases as means of evaluating the safety of medicines. We will look at safety issues from the point of view of the sponsor, the investigator and the regulator and learn how to develop and implement a risk management plan.
Healthcare Market Place
This module provides students with an understanding of the major principles associated with testing pharmaceutical compounds in human subjects. Over five days we will consider how a new medicine is selected for development, appraisal of toxicological and pharmacological data to aid dose selection in phase 1 clinical trials, and phase 1 clinical trial design and execution.
Key topics include: Preclinical assessment, first-in-human (FIH) study design, clinical trial dose selection, ethical principles in human experimentation, pharmacokinetic issues, biomarkers and surrogates, Phase 1 clinical trial monitoring and analysis, regulatory issues, and gene therapy/stem cell therapy.
Practical exercises will include case studies on aspects of early drug development.
Practical Clinical Pharmacology
This module explores all aspects of the marketing of medicines. We will consider market analysis and planning, advertising and codes of practice. There will also be sessions on health technology assessment and an introduction to pharmacoeconomics.
Teaching will be supplemented with case studies and practical exercises.
In this module, participants will learn how to acquire information on the scientific background, objectives and design of a clinical pharmacology study and to gain a comprehensive understanding of the planning, organisation and conduct of the study. This module will be very practical with the students attached to a principle investigator.
This module covers issues of preclinical safety testing, including what tests are needed to start and progress a clinical development programme. You will learn how to look for critical information within a toxicology report and will visit a major toxicology laboratory.
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.
Telephone: +44 (0)20 7848 4683 / +44 (0)20 7848 4158