PF6609: GxP - Regulatory and Best Practice Standards in the (Bio) Pharmaceutical Industry

Credit Weighting: 5
No. of Students: Min 10, Max 50.
Pre-requisite(s): None
Co-requisite(s): None
Teaching Period(s): Semester 1.
Teaching Methods: 6 x 3hr(s) Lectures (lectures / workshops - blended learning); 50hr(s) Directed Study; 32hr(s) Other (self-directed study)
Module Co-ordinator: Dr Sonja Vucen, School of Pharmacy.
Lecturer(s): Staff, School of Pharmacy.
Module Objective: To provide an overview of current regulations and their practical application in the development, licensing and registration of drugs, biologics, and medical device products.
Module Content: Introduction to regulatory affairs and (bio) pharmaceutical quality systems. Registration and licensing requirements for new medicinal products and facilities. An overview of cGMP requirements in the regulations. Selected topics on quality systems. Role and legal responsibilities of the Qualified Person. Pharmacovigilance and post marketing surveillance. Principles underpinning GCP, GLP, GDocP, GDP, GSP and GRP. Regulatory considerations for designing and conducting clinical trials. Medical device regulations. Regulatory approval pathway for biosimilars and advanced therapy medicinal products.
Learning Outcome: On successful completion of this module, students should be able to:
  • Develop personal insights into the importance of quality, safety and efficacy standards of medicines for human use.
  • Describe the key concepts and principles of GxP and their integration within the quality management system of (bio) pharmaceutical organisations.
  • Demonstrate the essential knowledge and skills needed for evaluating best practices in the (bio) pharmaceutical industry.
Assessment: Total Marks 100: Continuous Assessment 100 marks (2,000 word written assignment, 60 marks; MCQ exam, 40 marks).
Compulsory Elements: Continuous Assessment. Oral if required.
Penalties (for late submission of course/project work etc.): Where work is submitted up to and including 7 days late, 5% of the total marks available shall be deducted from the mark achieved. Where work is submitted up to and including 14 days late, 10% of the total marks available shall be deducted from the mark achieved. Work submitted 15 days late or more shall be assigned a mark of zero.
Pass Standard and any Special Requirements for Passing Module: 50%.
End of Year Written Examination Profile: No Formal Written Examination.
Requirements for Supplemental Examination: Marks in passed element(s) of Continuous Assessment are carried forward, Failed element(s) of Continuous Assessment must be repeated (as prescribed by the School of Pharmacy).

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