PHAR40320 Adv. Healthcare Reg. Affairs

Academic Year 2021/2022

The aim of this module is to further develop students understanding of regulatory affairs and their ability to apply important principles in regulatory affairs relating to the pharmaceutical industry.
The module will allow students to explore the interface between scientific understanding and regulatory interpretations by engaging in a problem-based-learning approach to some 'real-world' problems and scenarios from the pharmaceutical and biotechnology sectors.

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Curricular information is subject to change

Learning Outcomes:

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

1. interpret key regulatory requirements and guidelines for health products (pharmaceuticals, biologics and medical devices)
2. provide scientific, evidence-based justifications of common stakeholder positions
3. map the regulatory requirements over the life-cycle of a medicinal product
4. contribute to the preparation of a regulatory dossier
5. prepare and deliver a face-to-face overview of a product dossier

Student Effort Hours: 
Student Effort Type Hours
Lectures

6

Small Group

18

Autonomous Student Learning

80

Total

104

Approaches to Teaching and Learning:
Problem-based Learning
Group Work
Workshops
Online Materials 
Requirements, Exclusions and Recommendations
Learning Requirements:

Students must be be registered the 'Regulatory Affairs I' module (PHAR40330) to register for this module.


Module Requisites and Incompatibles
Co-requisite:
PHAR40330 - Intro to Regulatory Affairs


 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Assignment: Individual Assignment - End of Semester Unspecified n/a Graded No

60

Presentation: Group Presentation - End of Semester Unspecified n/a 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
• Peer review activities

How will my Feedback be Delivered?

Not yet recorded.

Name Role
Dr Hilary Cassidy Lecturer / Co-Lecturer
Assoc Professor Tara McMorrow Lecturer / Co-Lecturer
Mr Alan Morgan Lecturer / Co-Lecturer
Dr Craig Slattery Lecturer / Co-Lecturer