Session 1 - Research
The different functions within pre-clinical research are discussed in detail, including areas such as target identification, high throughput screening, candidate selection, translational science and personalised healthcare. Participants are usually able to take a biology or chemistry laboratory tour. A workshop is usually held where participants are able to consider the statistical issues that are pertinent to pre-clinical research, such as in-vivo study design.
Session 2 - Toxicology
This session explains what toxicology is and why it is needed in research and development of new compounds. There are several areas within toxicology, such as genetic and reproductive toxicology. Other topics covered include carcinogenicity, pharmacology and statistical approaches in toxicology studies. The session will usually include a workshop where participants are presented with toxicology issues to resolve.
Session 3 - Data Management & CRO’s
The DM part of the session covers database structure and design, CRF design, procedures for entering data, data validation, data quality and data transfer. There is usually a workshop as part of the session where participants are involved in discussing an example of a typical data management issue, such as designing CRFs or a data validation process. The CRO part of the session gives an overview of the role of a CRO, the history of CRO's, interactions between pharma companies and CRO's, the concept of customers, and the typical processes involved for a CRO when bidding for work. A workshop involving construction of a bid for a contract is usually included.
Session 4 - Clinical Trials
This session focuses on the overall clinical development plan, with a focus on phases I-III trials. Key documents, roles and activities are described including trial protocols (incl. sample size estimation), statistical analysis plans, clinical study reports as well as the trial set-up process, monitoring and good clinical practice. Other topics covered can include conducting analysis, statistical programming and CDISC, operations, safety, regulatory affairs and medical writing. A workshop is normally included which can involve for example, participating in a DMC, study management team in crisis or CDP planning.
Session 5 - Reimbursement
This session gives an overview of the process and modelling aspects of economic evaluation of medicines. The presentations explain the methods and measures used in economic evaluation and the participants usually have an opportunity to do a critical assessment of an economic evaluation. The use of meta-analysis and systematic reviews and their use in evaluations are also discussed with an exercise to review a published systematic review.
Session 6 - Marketing
The marketing session is intended to give an overview of what happens to a drug after regulatory approval, and reimbursement and its subsequent launch. It covers the role of market research, how analysis of the market can improve the chances of a successful product launch and how the sales function works. Other topics include regulatory issues relating to promotion of drugs, increasing generic market and responses to changes in the government financing of the NHS. The session will usually include a workshop during which delegates are encouraged to propose a marketing plan for a hypothetical drug