Fundamentals in Regulatory AffairsThis programme has been designed to meet the growing requirements of Irish companies in filling regulatory assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from Irish Medtech Association’s Regulatory and Quality Working Group. In particular, this industry led programme will assist companies as they prepare for the new EU regulatory framework and offer unique flexibility to companies to adapt rapidly to changing regulatory workloads ahead of the entry into force of the new EU Medical Device and IVD Medical Device Regulations.The course will enable personnel in the medical technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. Upon successful completion of the programme, participants receive 9 ECT credits of a Level 8
Programme DescriptionThe regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to international medical device regulations for safety and efficacy. Regulatory Affairs is one of the most in-demand professions in the medical device industry.
The aim of the course is to introduce participants to the Fundamentals of Regulatory Affairs, providing them with basic knowledge of the regulations as they apply to the medical technology industry. This course will cover international regulatory requirements with emphasis on the US, European Union, Japan, Australia, Canada and other global territories with market implications. Regulatory requirements for each system will be presented including classification, marketing submissions and post-approval requirements. Developing regulatory strategies for global market introduction and organising for the challenges of global regulation will be considered.
The course content will address the following themes:
1. What regulatory and certification bodies look for from Regulatory Affairs function in an organisation.
2. Similarities and differences between EU, US and Global regulatory market requirements, with special attention to the recently published MDR and IVDR texts.
3. Risk and Risk management and corresponding links to Post Market Surveillance for Regulatory Affairs.
4. Quality Management Systems and where regulations align for the Business and Regulatory function.
5. Clinical Studies and the Design Process including the various interfaces with Regulatory Affairs.
6. Significance of product labelling, associated promotional material and device changes and the watch-outs for Regulatory Affairs
Who should attendEntry requirement will be minimum Level 7 with two years’ experience working in a regulated environment in the life sciences sector.
Prior experiential learning will be assessed using guidelines recommended by the Academic Council of University of Limerick.
AccreditationThe course will be accredited by University of Limerick, with 9 credits of a level 8.
Note: Approximately 90 – 100 hours are required outside course work.
Clayton Hotel, Galway
March 6, 13, 20, 27. April 10, 24. May 1, 8, 15, 22, 29, 31. (Classroom days 09:00-17:00 March 6th, April 24th, May 31st. )