Fundamentals in Regulatory Affairs - Introduction

The aim of this module is to introduce students to the Regulatory Affairs profession.  It provides an initial introduction to the key regulatory concepts and the primary module topics of the programme.  Each week students will explore a key regulatory topic which will become the main subject of in-depth learning  within a few weeks or in Semester 2.  As an example, the significane of a quality management system will be examined on week 2 with students delving into the context and application of a QMS in detail commencing in week 4.  

This methodology helps students to gain perspective on the regulatory framework from the outset and the proficiency to compartmentalize the global regulators and associated sanctions they can impose.   This approach also mimics a medical device lifecyle and induction to the key processes such as risk, design & human use clinical evaluation will augment the educational experience.  As students acquire a degree of knowledge on the key regulatory topics this will prepare and encourage them to contemplate and engage as a regulatory professional throughout the programme.  

The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance with international medical device regulations for safety and efficacy. Regulatory Affairs is one of the most in-demand professions in the medical technology industry in Ireland and beyond.  

National Regulatory Bodies & Industry Leaders guest speakers will emphasise the significance of the role to students through live presentation & pre-recorded media.  The primary tutors who introduce each of these subjects initially will be expanding in later in-depth modules.  

1. Identify and illustrate the medical technology global regulatory framework, outline the regulations and regulators.  Compile and conclude the key elements that influence regulatory strategy from a product lifecycle context i.e. the QMS system applicable to regulatory jurisdiction and device classification 

2. Explain the relevance of the EU, U.S. and other major Global Regulations for the RA Professional including an understanding of the differences and influence of key market Regulators.  Justify and critique the appropriate market application process to match the device classification.

3. Develop initial regulatory processes for the business and analyse device changes to ensure they meet regulations.   Evaluate the role of Design, Risk Management and Clinical studies in the overall regulatory context and assess post market experience for inclusion.

4. Demonstrate an understanding of the concepts underpining the implications of medical device safety monitoring post release including Vigilance and Post Market Surveillance reporting.

5. Compare and contrast regulations and select the minimum business applications required to establish appropriate, consistent and practical procedures and policies for the industry.