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 |
|---|---|
| Specified Learning Activities | 40 |
| Autonomous Student Learning | 80 |
| Lectures | 12 |
| Small Group | 18 |
| Total | 150 |
Students must be be registered the 'Regulatory Affairs I' module (PHAR40330) to register for this module.
| Description | Timing | Component Scale | % of Final Grade | ||
|---|---|---|---|---|---|
| Assignment(Including Essay): Pharmaceutical Dossier and Critical Analysis | Week 14 | Graded | No | 70 |
No |
| Group Work Assignment: Group Presentation | Week 11 | Graded | No | 30 |
No |
As part of UCD's student support, under the Additional Consideration policy, extensions may be available for the following assessments in the module: Assignment (including essay/poster), Portfolio, Reflective Assignment, Report(s), and Individual Project.
| 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 |