PHAR40240 Regulatory Affairs in Science

Academic Year 2022/2023

The aim of this module is to outline the role of regulatory affairs in the pharmaceutical, medical device, foods and cosmetics industries.
A wide range of products and services available on the open market are subject to regulation by government agencies. This is generally for the protection of the public, to ensure products are safe and that they deliver some societal benefit. Human medicines and medical devices, veterinary medicines and agrichemicals, foods and food supplements are some of the most strictly regulated products in this regard. It is the responsibility of the Regulatory Affairs professional to ensure that manufacturers of regulated products in these industries are complying with all regulations and laws concerning their products.
Students will explore the global regulatory environment and learn about the importance of international standards and harmonised guidelines in the pharmaceutical and medical device sectors. Students will learn about all aspects of medicines regulation throughout the drug development process from initial discovery, on to pre-clinical and clinical development, and through to pharmacovigilance.
Students will also learn about current issues in the regulatory affairs world from industry-based regulatory affairs professionals and representatives of national regulatory bodies. Current ‘hot-topics’ including regulation of advanced therapies (biotherapeutics, gene therapies, vaccines etc.), the evolution of the biosimilars market and the increasing role of pharmacoeconomics will be discussed. In addition, the incumbent new EU Medical Device, and Clinical Trials Regulations will be topics of focus.
The module will explore the interface between scientific understanding and regulatory interpretations, arming students with the knowledge and vocabulary necessary to operate in the world of regulatory affairs.

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Curricular information is subject to change

Learning Outcomes:

On completion of this module, students will be able to:

1. describe the global regulatory landscape for medicinal products (pharmaceuticals, biologics and medical devices)
2. interpret important regulatory language and terminology
3. describe the regulation of novel foods and food ingredients
4. discuss the potential impact of new EU legislation in the areas of Medical Devices and Clinical Trials
5. outline the key regulatory documentation required for successful marketing authorisations

Student Effort Hours: 
Student Effort Type Hours
Autonomous Student Learning

80

Lectures

16

Seminar (or Webinar)

4

Total

100

Approaches to Teaching and Learning:
Lectures
Online Content
In class quizzes
External Speakers 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Assignment: Individual Assignment - Choice of topics provided Coursework (End of Trimester) n/a Graded No

60

Examination: MCQ-based Assessment End of trimester MCQ No Graded No

40


Carry forward of passed components
No
 
Resit In Terminal Exam
Summer No
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, on an activity or draft prior to summative assessment
• Feedback individually to students, post-assessment
• Self-assessment activities

How will my Feedback be Delivered?

Not yet recorded.

Timetabling information is displayed only for guidance purposes, relates to the current Academic Year only and is subject to change.
 
Spring
     
Lecture Offering 1 Week(s) - 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33 Fri 11:00 - 12:50