This online module is an optional module available for extra credit while students are on placement in year 3. It is designed to give students an overview of regulations as stated in the U.S. Code of Federal Regulations (CFR), EudraLex Directives and Annexes, and Emerging Market regulations for the (bio)pharmaceutical and medical device industries. The relationship between regulatory requirements and legal accountability is demonstrated and fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control, and validation are introduced. Case studies are utilized to support this.
The module will support the learner to enter the (bio)pharmaceutical and medical device industry with an understanding of how to optimize patient health and business success by mobilizing enterprise-wide quality effectiveness through innovative systems and critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence.
The curriculum has been developed by Pathway for Patient Health, and the module is offered through the TU Dublin virtual learning environment in partnership with them.
Pharmaceutical Regulatory Requirements
History of and introduction to FDA Regulations, Quality and Global Regulations and Global HarmonizationThe Power of the Quality System Regulations – Medical Devices, The Power of the Quality Management System - PharmaceuticalsGood Supply Practices, Quality versus ComplianceDrug Development Process, Device and IVD DevelopmentHistory of Clinical Trials and Use of Clinical Trial DataProduct Labeling, Validation OverviewPathway to Drug Approval and Pathway to Medical Device ApprovalA Glimpse into Manufacturing OperationsComputer Systems, Change controlQuality for the 21st Century - What to Measure and How, Artificial Intelligence and CultureFailure Investigations, FDA Inspections and Inspection Outcomes, FDA EnforcementMajor Court Cases, Recalls, Post-Market Surveillance and Project Management
This is an online module. Powerpoint slides and videos prepared by an industry expert as well as open source option further reading and viewing resources are made available over 14 weeks. The videos amount to 35 viewing hours.
Weekly knowledge checks are facilitated through multiple choice quizzes and learners are asked to apply their knowledge in short assignments every 3 weeks. These are supplemented by a mid module and end of module timed open book exam
|Module Content & Assessment