The aim of the module is to introduce participants to the integration of non-clinical tests into overall drug development plans, and outline the various types of clinical studies. This module will cover the key strategic and operational issues in the clinical trial process, in terms of legislative requirements and GCP. This will also include ethical provisions for the protection of clinical trial subjects. An overview of pharmacovigilance responsibilities and risk management throughout drug development and lifecycle will be considered. Students will receive a solid grounding in the legal framework for clinical trials in the EU, including the new Clinical Trial Regulation. They will be taught about the need for Scientific Advice in the drug development programme.

1. The need for pharmacology, pharmacokinetic and toxicology data. The integration of non-clinical tests into the overall drug development plan. 2. The legal framework for Clinical Trials in the EU and an outline of the various types of clinical studies. 3. The key strategic and operational issues in the clinical trial process, in terms of legislative requirements and GCP. Ethical provisions for protection of clinical trial subjects. 4. The Non-Clinical and Clinical sections of the Marketing Authorisation / Clinical Trial Application. 5. Overview of pharmacovigilance responsibilities and risk management throughout drug development and lifecycle. 6. Scientific Advice.

On successful completion of this module, students will be able to: 1. Demonstrate a knowledge of the integration, necessity, and location of non-clinical data in the drug development process. 2. Describe the various types of clinical trial designs and associated terminology. 3. Demonstrate a knowledge of the requirements of pharmacology, pharmacokinetic and toxicology data, and the role of this data in key regulatory documentation. 4. Demonstrate a knowledge of strategic and operational issues in the clinical trial process and how they interact with legislative requirements and GCP. 5. Demonstrate an understanding of the importance of seeking Scientific Advice early in the development plan of a medicine including how to access and maximise it.

On successful completion of this module, students will be able to acknowledge and discuss their professional and ethical responsibility for the protection of clinical trial subjects - using the skills and knowledge gained from the course, students will become major contributors to regulatory teams within their own organizations.

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The module as outlined in the syllabus, is delivered as a combination of tutor lead direct learning and tutor lead non-direct learning i.e. a combination of classroom and on-line lectures. Intersession work will be facilitated through an online learning platform. The tutors will be Subject Matter Experts (SMEs) in the area and will be knowledgeable on current legislations and application. Graduate attributes: On successful completion of this module, students will: (i) Demonstrate a knowledge of the requirements and need for pharmacology, pharmacokinetic and toxicology data in the regulatory development process including where they fit in the Marketing Authorisation /Clinical Trial Application. (ii) Demonstrate a knowledge of the responsibility of pharmacovigilance and the appropriate risk management measures throughout the drug development and lifecycle process. (iii) Demonstrate an understanding of the importance of seeking Scientific Advice early in the development plan of a medicine including how to access and maximise it. (iv) Be creative in effectively interpreting the scope of clinical and non-clinical studies. (v) Perform successfully as collaborative members of a regulatory team contributing to the efficacy to biopharma products produced in Europe. (vi) Articulate in their explanation of the ethical implications for regulatory professionals with respect to clinical trial subjects.