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 | 12 |
| Small Group | 18 |
| Specified Learning Activities | 40 |
| Autonomous Student Learning | 80 |
| Total | 150 |
Students must be be registered the 'Regulatory Affairs I' module (PHAR40330) to register for this module.
| 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 |