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Curricular information is subject to change
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 Type | Hours |
---|---|
Lectures | 20 |
Seminar (or Webinar) | 10 |
Autonomous Student Learning | 85 |
Total | 115 |
Not applicable to this module.
Description | Timing | Component Scale | % of Final Grade | ||
---|---|---|---|---|---|
Assignment: Individual Assignment - choice of topics provided | Coursework (End of Trimester) | n/a | Graded | No | 60 |
Multiple Choice Questionnaire: End-of-semester MCQ | End of trimester MCQ | 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
• Self-assessment activities
Not yet recorded.
Name | Role |
---|---|
Assoc Professor Tara McMorrow | Lecturer / Co-Lecturer |
Dr Craig Slattery | Lecturer / Co-Lecturer |