Show/hide contentOpenClose All
Curricular information is subject to change
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 Type | Hours |
---|---|
Lectures | 6 |
Small Group | 18 |
Autonomous Student Learning | 80 |
Total | 104 |
Students must be be registered the 'Regulatory Affairs I' module (PHAR40330) to register for this module.
Description | Timing | Component Scale | % 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 |
Resit In | Terminal Exam |
---|---|
Summer | No |
• Feedback individually to students, on an activity or draft prior to summative assessment
• Feedback individually to students, post-assessment
• Peer review activities
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 |