Clinical Research Development Ireland e-Learning
The CRDI / CÚRAM partnership drives the project ‘Developing Key Structures and Resources to Support Medical Device Clinical Research in Ireland’.
Education and Training
A core objective of the CRDI / CÚRAM partnership project is the development of key information and training tools to support excellence in medical device research in Ireland. This includes the provision of existing, and development of new, CRDI medical device based e-Learning education and training resources for CÚRAM researchers. It also comprises the development and maintenance of a knowledge portal and clinician database to support MedTech translation.
This work complements existing CÚRAM professionalism and career development opportunities, which include the Research Integrity and Future Innovators Training programmes.
CRDI e-Learning assets are integrated into the CÚRAM Education and Training programme by the CÚRAM Education and Training Steering Committee comprising representation from CRDI as well as medical device researchers from academia and industry, clinician scientists, teaching and learning leads, and clinical trials methodology experts.
Selected courses developed by the CRDI / CÚRAM Partnership include:
Fundamentals of Medical Device Design and Regulation (Module # MD8000)
This course, accredited for 5 ECTS in NUIG, is designed to impart important industry, research and regulatory concepts relevant to the entire life cycle of medical device development. It comprises two modules
a) Principles of Medical Device Design
Introduces the learner to the fundamentals of medical device design, delivering key concepts such as biocompatibility and processes involving biomaterials and biomechanics. It also discusses the multi- and inter-disciplinary nature of the field and describes the medical device industry in Ireland (see video clip below).
b) EU Regulation of Medical Devices
Introduces the EU Medical Devices Regulatory Framework, describes CE marking and conformance assessment processes, their requirements and the obligations placed on the manufacturer in this regard. This knowledge is designed to support device design and development, and facilitate further study or training in the area of EU medical device regulation (see video clip below).
Case Studies in Drug Discovery and Development
This course introduces the concepts involved in traditional drug discovery and development processes in the pharmaceutical industry. To support module delivery, case studies, delivered by academic and industry experts, describe small molecule and biotech molecule development from discovery to market. Also discussed is the significant role of large pharma in the development of these molecules, their financing of, and the logistics of, clinical trials as well as the regulation of these molecules for market (see video clip below).
Principles of Medical Device Design
This e-Learning module integrates the approaches of engineering and life sciences.
EU Regulation of Medical Devices
This module provides an introduction to regulation of medical devices within the European Union.