Quality and Regulatory Affairs

The Quality and Regulatory Affairs Manager ensures that research undertaken within the CRF is conducted to the highest standards and is available to assist investigators with their research by:

• Providing advice on development of research protocols and other essential documents
• Assisting with Research Ethics and Health Products Regulatory Authority (HPRA) submissions
• Providing ICH GCP and other regulatory training for study staff
• Conducting audits of ongoing studies to ensure compliance with national and international legislation and guidelines.

The Quality and Regulatory Affairs Manager is available to provide advice throughout the set-up, conduct and reporting phases of your research project.