Quality Training

Fundamentals in Regulatory Affairs for Medtech Industry

This 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 Description

The 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

Note: Approximately 90 – 100 hours are required outside course work.

3 virtual full day classrooms 09.00 to 17.00  + weekly lectures 18.30 to 20.30 and Pre-recordings + weekly live tutorials 18.30 to 19.30

Classroom(Virtual)	Introduction to Programme
Online	Quality Management Systems purpose & structure
Online	EU Regulation significant changes
Online	U.S. Regulations
Online	Clinical Studies
Online	Assessment 1 - QUIZ on sections 1 to 5 (Date pre-notified)
Classroom(Virtual)	Product Design & Risk Management
Online	Global Regulations
Online	Regulatory Incident Reporting & Post Market Surveillance
Online	Device Changes Post Approval
Online	Product labelling, Promotional Material & UDI
Online	Assessment 2 - QUIZ on sections 6 to 11 (Date pre-notified)
Online	Strategic Approach to RA (Industry Expert at Dir or VP level)
Classroom	Team Case Study Presentations (Live or Pre-Recorded tbc)
Grading	Submission Deadline for grading

Who should attend

Entry requirement will be minimum Level 7 with two years’ experience working in a regulated environment in the life sciences sector.

Accreditation

9 credits of a level 8.

Upcoming dates:

No training dates available at the moment.