The Regulatory Environment Course Descriptor

Course Summary

This course promotes all aspects of quality control, awareness and adherence to quality guidelines and regulations, with a focus on accuracy and safety in all aspects of bioscience work. It examines the need for health and safety regulations and the use of risk assessments to ensure the best possible understanding of the contexts within which scientists operate and how to mitigate accidents. Learners will examine the internal and external regulatory environment pertinent to the bioscience and health sectors, for example Medicines & Healthcare Products Regulatory Authority (MHRA), Control of Major Accident Hazards (COMAH), Control of Substances Hazardous to Health (COSHH), Good Laboratory Practice (GLP) and Good Manufacturing Practice.

Course Aims

• For learners to understand and be able to implement safe laboratory working practices and regulations.
• For learners to understand the regulatory environment with which the bioscience and health sectors operate, including historical perspectives and ethics.
• For learners to understand modern regulatory and safety advances such as pharmacovigilance and fast track approval.

Learning Outcomes

On successful completion of the course, learners will be able to:

Knowledge and Understanding

Subject Specific Skills

Transferable and Professional Skills

Teaching and Learning

This is an e-learning course, taught throughout the year. 

This course can be offered as a standalone short course.

Teaching and learning strategies for this course will include: 

• Online learning
• Online discussion groups
• Online assessment

Course information and supplementary materials will be available on the University’s Virtual Learning Environment (VLE).

Learners are required to attend and participate in all the formal and timetabled sessions for this course. Learners are also expected to manage their self-directed learning and independent study in support of the course.

The course learning and teaching hours will be structured as follows:

• Off-the-job learning and teaching (6 days x 7 hours) = 42 hours
• One-the-job learning (12 days x 7 hours) = 84 hours (e.g. 2 days per week for 6 weeks)
• Private study (4 hours per week) = 24 hours

Total = 150 hours

Workplace assignments (see below) will be completed as part of on-the-job learning.

Assessment

Formative

Learners will be formatively assessed during the course by means of set assignments. These will not count towards the final degree but will provide learners with developmental feedback. 

Summative

Assessment will be in two forms:

Feedback

Learners will receive formal feedback in a variety of ways: written (via email or VLE correspondence) and indirectly through online discussion groups. Learners will also attend a formal meeting with their Academic Mentor (and for apprentices, including their Line Manager). These bi or tri-partite reviews will monitor and evaluate the learner’s progress.  

Feedback is provided on summatively assessed assignments and through generic internal examiners’ reports, both of which are posted on the VLE.

Indicative Reading

Note: Comprehensive and current reading lists for courses are produced annually in the Course Syllabus or other documentation provided to learners; the indicative reading list provided below is used as part of the approval/modification process only.

Books 

• Lezotre, P-L. (2014). International cooperation, convergence and harmonization of pharmaceutical regulations : a global perspective. Amsterdam : Elsevier ; Oxford ; Sand Diego, CA : Academic Press 2014
• Fleming, D. O., & Hunt, D. L. (2006). Biological safety : principles and practices (4th ed.). Washington, D.C. : ASM Press 2006
• Brock, W. J., Hastings, K. L, McGown, K. M. (2013). Nonclinical safety assessment a guide to international pharmaceutical regulations. Chichester, West Sussex : John Wiley & Sons.

Journals

Learners are encouraged to read material from relevant journals on the regulatory environment as directed by their course leader.

Electronic Resources

Learners are encouraged to consult relevant websites on the regulatory environment.

Indicative Topics

• Quality management
• Health and safety
• Regulations and safety protocols