Quality And Regulatory Affairs Manager

Emma Deenihan‌

The CRFG have a dedicated Quality and Regulatory Affairs Manager and a quality system which is compliant with Good Clinical Practice, ISO 14155 and all required national and international standards and regulations. This system provides the framework for assuring quality and compliance in all our clinical studies. This systematic approach recognises that quality is integrated into the entire clinical study process to ensure subject protection and to deliver high quality data. Other services provided include:

  • Input to the design and content of the research protocols for compliance and ease of approval

  • Preparation, coordination and submission of studies for the HPRA and ethics committee approval, and the coordination of all subsequent post-approval activities

  • Periodic study monitoring to ensure patient protection and to validate the integrity of the study data

  • An internal audit system and management of external audits by the HPRA and Sponsors

  • The Quality and Regulatory Affairs Manager works closely with the study management team as a source of quality and regulatory advice to ensure adherence with ICH GCP and all required regulations.

  • The Quality and Regulatory Affairs Manager provides leadership on all quality and regulatory decisions to ensure compliance across the full life cycle of a study.