Module manager: Dr Anton Calabrese
Email: A.Calabrese@leeds.ac.uk
Taught: 1 Sep to 31 Mar View Timetable
Year running 2026/27
A first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above. Relevant experience may be taken into account.
| BIOL5323M | Prac Skills for Regulatory Env |
BIOL5325M - Practical Skills for a Regulatory Environment (part-time)
This module is not approved as an Elective
The module is available to working professionals only (Labcorp employees). Students will demonstrate the competencies required to operate effectively within a regulated biopharmaceutical environment. They will leverage their professional experience to illustrate how they meet the module’s learning outcomes, which encompass regulatory frameworks, operational processes, and best practices in drug development. A core component of the module is developing and demonstrating a solid understanding of the principles that underpin effective regulation in a biopharmaceutical environment.
On completion of this module, students will be able to:
Understand the principles and practices underpinning regulated environments in biopharmaceutical development.
Critically reflect on professional roles and responsibilities within the drug development process.
Communicate technical or operational information effectively via report writing and presentation.
On completion of the module will be able to:
1. Critque regulatory frameworks and compliance requirements.
2. Evaluate processes and practices relevant to biopharmaceutical development from their professional perspective.
3. Analyse and interpret data and present their findings in writing and orally in a format suitable to a client or regulatory authority.
4. Contribute to shared decision‑making and integrate peer and tutor feedback.
5. Analyse quantitative or qualitative data to draw informed conclusions.
6. Communicate ideas via structured written reports and oral presentations.
during the module. The module will cover the following:
An introduction to the regulations governing biopharmaceutical drug development, with emphasis on key regulatory frameworks and standards.
Maintaining accurate record keeping in a regulated environment, ensuring compliance and traceability. Locating relevant regulatory guidance and preparing scientific documentation that meets compliance requirements.
The principles and practices of validation, highlighting its role in assuring product quality and process reliability.
Reflecting on professional practices and technical competencies gained from working in a biopharmaceutical development environment.
| Delivery type | Number | Length hours | Student hours |
|---|---|---|---|
| Supervision | 2 | 1 | 2 |
| Seminars | 10 | 1 | 10 |
| presentation | 1 | 1 | 1 |
| Lecture | 5 | 1 | 5 |
| Private study hours | 282 | ||
| Total Contact hours | 18 | ||
| Total hours (100hr per 10 credits) | 300 | ||
A member of academic staff will be allocated as a tutor to each student. They will meet during scheduled tutorials to support the learning in this module as groups and as individuals.
| Assessment type | Notes | % of formal assessment |
|---|---|---|
| Essay | 3000 word essay that demonstrates with specific examples how the student meets the learning outcomes of the module through their professional practice. | 50 |
| Oral Presentation | Oral presentation on content of essay, 20 min presentation with questions | 30 |
| Literature Review | 1000-word essay that demonstrates understanding of a technique or process that is new to them and is relevant to industry. | 20 |
| Total percentage (Assessment Coursework) | 100 | |
Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated
Check the module area in Minerva for your reading list
Last updated: 30/04/2026
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