Quality Assurance and control

Emma Deenihan

Quality and Regulatory Affairs Manager

The Quality and Regulatory Affairs Manager, Emma Deenihan, has over 9 years of experience of working in a regulated environment; including 4 years experience of working in quality assurance in the medical device industry, and 3 years experience of working with clinical trials and in clinical research. She has excellent working knowledge of quality management systems, EU Directives 2001/20/EC and 2005/28/EC, ICH GCP, MDD, 21 CRF 860, IVDD, ISO 13485:2003, ISO 14155-1, ISO 14155-2, and other Irish and International Standards and Regulations. She has participated in, and chaired, external quality systems audits by the IMB, FDA, EU and other International regulatory organisations. The Quality and Regulatory Affairs Manager offers advice and assistance with regulatory and ethical submissions to the Irish Medicines Board, and the Central Ethics Committee. She works closely with the study management team as a source of quality and regulatory advice on the interpretation of information to ensure adherence with ICH GCP and relevant regulations. She also provides leadership in quality and regulatory decisions to ensure compliance across the life cycle of a study.

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