Drug Regulation and Safety - 0990066

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Module will run

Occurrence	Teaching period
A	Spring Term 2024-25

Module aims

To provide an opportunity to apply and consolidate theoretical and conceptual knowledge.

To gain a solid understanding of the regulatory environment used within pharmaceutical industry for drug development and production.

To derive an understanding of how scientific principles are used to allow effective regulation through the analysing, interpreting and presenting quantitative data obtained in the manufacture, laboratory and clinical trial setting.

To develop analytical skills based on reflection and by engaging in discussions with fellow students and tutors.

Module learning outcomes

On successful completion of this module participants will be able to:

1. Illustrate and demonstrate extended knowledge of the fundamental principles of regulation in drug development and production;

1. Analyse and evaluate the purpose of effective drug regulation.

1. Critically interpret experimental design, data handling and presentation of results, used for regulatory purposes.

Module content

The module comprises 8 seminars sessions. Teaching will be spread across Trimester 2.

Topic 1: Why regulate drugs?

History of drug development, key principles (GLP, GCP, GMP), outline of the drug discovery process and regulations that apply across (UK/EU/FDA).

Topic 2: Applying for Marketing Authorisation

Required components for submission of an application for MA, timelines and risks/costs for companies, planning studies through the pathway. Paediatric Implementation Plans.

Other products that may have additional requirements: Vaccines, ATMPs, Medical Devices

Topic 3: Pre-Clinical and Safety Pharmacology Studies

GLP, Home Office, ICH S6 and ICH S7A

Topic 4: First in Human/ Investigational New Drug Application

Components of an application for FIH study, Clinical Trials Regulations, Risks/mitigations for FIH, REC, GCP

Topic 5: Phase II and III trials

Determining safety, dose and efficacy through a series of studies. Information required for regulatory approvals, reporting, possible risk-adaptations in later studies.

Topic 6: Pharmacovigilance

Reporting requirements during clinical studies, risk management plan, post-marketing surveillance and reporting systems.

Topic 7: Manufacturing, Labelling, SmPC

Data and details required to be added to file for marketing authorisation, final steps. Considerations for content of patient information.

Topic 8: Post-marketing

Pricing and reimbursement (NICE), advertising and promotion (MHRA Blue Guide)

Indicative assessment

Task	% of module mark
Essay/coursework	100

Special assessment rules

None

Indicative reassessment

Task	% of module mark
Essay/coursework	100

Module feedback

Students will receive written feedback by Mid Trimester 2.

Indicative reading

.