58798 Courses delivered Online

Clinical trial design establishes the framework upon which the clinical trial process will be conducted, and sets the objectives of the trial. The application for marketing approval, submitted to the regulatory authorities, will provide clinical data reflecting the trial design. Since trial design impacts the whole drug development process and lifecycle, particular care and due diligence is essential. This short course provides an overview of the main types of study design.

Regulatory authorities tend to abide by the maxim that ‘If it isn’t documented, it didn’t happen’. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of GCP and compliance with regulatory requirements, as well as enabling effective management of the trial. In this short course we describe important examples of the documents designated by ICH GCP as essential to the conduct of a clinical trial.

The demands on quality from clinical trials are increasing. Quantitative aspects of clinical trials, such as the mass of study data to be collected, the multiple investigational sites, and the need to meet predetermined timelines, often supersede qualitative features. Therefore, addressing basic requirements for quality management is essential when preparing a clinical trial. This short course describes the core elements required for the establishment of a clinical trial and provides an overview of the role of the sponsor in supporting and improving trial quality.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data in applications for marketing approval. The International Council for Harmonisation's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This short course explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents that are the source of GMP rules. Finally, it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.

This workshop will provide all the techniques and support to write confidently with a broad calligraphy pen.