MEDICINES REGULATION - 2027/8

Module Overview

In this module, you will learn how scientific drug development is integrated with global regulatory frameworks that ensure quality, safety, and efficacy. You will explore how regulatory requirements shape decision-making across the pharmaceutical lifecycle and gain insight into the interaction between science and law. The module prepares you for careers in regulatory affairs, pharmaceutical R&D, manufacturing, clinical research, quality assurance, and pharmacovigilance.

Module provider

Chemistry and Chemical Engineering

Module Leader

ZARMPI Panagiota (Chst Chm Eng)

Number of Credits: 15

ECTS Credits: 7.5

Framework: FHEQ Level 5

Module cap (Maximum number of students): N/A

Module Availability

Semester 2

Prerequisites / Co-requisites

None

Module content

Indicative content includes
Introduction to medicines regulation: role of regulation, overview of product lifecycle, historical failures, agencies.
Drug discovery and medicinal chemistry: target selection validation, chemical characterisation requirements, prodrugs and regulatory justification
Pharmacology and non-clinical development: safety, toxicity, investigator¿s brochure.
Biopharmaceutics and formulation development: BA/BE, ADME and regulatory relevance, biowaivers, food-effects, IVIVC, innovation.
Pharmaceutical manufacturing and analysis: GMP, scale-up and tech transfer, ICH, regulatory documentation.
Clinical trials: clinical phases, ethics and governance, regulatory submissions.
Submissions and approval pathways: CTD.
Post-marketing surveillance: pharmacovigilance, lifecycle management.

Assessment pattern

Alternative Assessment

None

Assessment Strategy

The assessment strategy is designed to provide you with opportunities to demonstrate understanding of core principles while developing transferable skills essential for a career in pharmaceutical sciences.
Thus, the summative assessment for this module consists of:

• Portfolio (addresses learning outcomes: 2,3 and 4)

• Oral presentation: addresses learning outcomes: 1, 3 and 5

Formative assessment is designed to support your learning and development by providing ongoing feedback and opportunities to consolidate knowledge, develop practical skills, and link theory to practice. It includes activities such as in-class quizzes, problem-solving exercises, workshops, and group discussions.
In laboratory sessions, formative assessment is provided through guided worksheets, and informal feedback from instructors, enabling you to prepare for experiments, interpret results, and refine practical techniques before submitting summative lab reports. These activities are intended to help you identify areas for improvement, enhance critical thinking, and develop transferable skills such as teamwork, scientific communication, and data analysis, ensuring you are well-prepared for the summative assessments and for progression to more advanced pharmaceutics content in later years.

Feedback will be provided throughout the module during lectures, through interactions in laboratory and workshop sessions, and on individual laboratory reports. This will include general guidance to the whole group as well as specific feedback on work to support learning and development. In addition, one-to-one feedback can be requested by appointment with the module leader or relevant lecturer, providing opportunities for further discussion and clarification of concepts.

Module aims

• Understand the end-to-end drug development pipeline.
• Apply regulatory principles to drug design, formulation, manufacture, and testing.
• Critically evaluate preclinical and clinical data.
• Interpret global regulatory submissions.
• Appreciate ethical, legal, and quality requirements for medicines approval.
• Develop professional competencies aligned with industry and regulatory agencies.

Learning outcomes

Methods of Teaching / Learning

The learning and teaching strategy is designed to: provide you with a solid theoretical foundation in the subject matter while also developing practical, cognitive, and transferable skills essential for future careers.
The learning and teaching methods include:
Lectures: delivered primarily through PowerPoint and led by experienced members of academic staff with subject-specific expertise. The lectures will focus on introducing key regulatory concepts. Sessions will be interactive, with regular opportunities for students to ask questions, engage in guided problem-solving and reflective thinking, and receive timely feedback from staff and peers.
Workshops: delivered by experienced academic staff with subject-specific expertise and will adopt a problem-based learning approach centred on relevant, real-world scenarios. Students will be provided with structured exercises that encourage application of core concepts, critical thinking, and professional judgement. Dedicated time will be allocated for students to work through tasks individually and collaboratively, with ongoing opportunities to interact with the lecturer, ask questions, and engage in discussion. Each session will conclude with lecturer-led feedback, including worked solutions and guided reflection, to consolidate learning and support the development of transferable skills relevant to future academic study and professional practice.

Indicated Lecture Hours (which may also include seminars, tutorials, workshops and other contact time) are approximate and may include in-class tests where one or more of these are an assessment on the module. In-class tests are scheduled/organised separately to taught content and will be published on to student personal timetables, where they apply to taken modules, as soon as they are finalised by central administration. This will usually be after the initial publication of the teaching timetable for the relevant semester.

Reading list

https://readinglists.surrey.ac.uk
Upon accessing the reading list, please search for the module using the module code: CHE2048

Other information

The school of Chemistry and Chemical Engineering is committed to developing graduates with strengths in Employability, Digital Capabilities, Global and Cultural Capabilities, Sustainability, and Resourcefulness and Resilience.
In this module, you will develop strong employability skills through practical experience with regulatory processes used in pharmaceutical and clinical research settings. You will build digital capabilities by using online regulatory databases, analysing datasets, and preparing submission-style documents. You will also develop global and cultural capabilities by comparing international regulatory systems and considering ethical issues in multinational trials. Finally, the module supports sustainability by exploring responsible lifecycle management, regulatory risk reduction, and the wider societal and environmental impact of drug development and manufacturing.

Programmes this module appears in

Please note that the information detailed within this record is accurate at the time of publishing and may be subject to change. This record contains information for the most up to date version of the programme / module for the 2027/8 academic year.