Diarmuid Cahalane – Co-Founder, Chief of Regulatory Affairs & Director, P4ML

    • Diarmuid Cahalane – Co-Founder, Chief of Regulatory Affairs & Director, P4ML's presentations

    Diarmuid Cahalane is a serial entrepreneur and mentor who has been working as an adviser to the technology and life sciences sectors for over 20 years. He is recognised for his strengths in risk analysis, remediation, cost reduction and compliance. In 1997, he established his own regulatory consulting company, and went on to work with many of the world’s leading life science companies.

    His level of expertise in Medical Devices is particularly strong given that he has worked on validation of software as a medical device with Guidant, Johnson & Johnson, and others. He contributed to the Pharmaceutical Industry Computer Systems Validation Forum (PICSVF) in 1994, which subsequently became known as the Good Automated Manufacturing Practice (GAMP) forum. In 1997 he participated in meetings with the FDA prior to the publication of 21 CFR Part 11. In 1999, he signed a global professional services agreement with Schering Plough, which led to his company completing projects in Singapore, US, and Germany as part of a global Computer Systems Validation Remediation Project.

    In addition, Diarmuid has successfully provided accreditation services to hospitals enabling them to get their pathology laboratories accredited to ISO15189 quality standards. Hospital clients include the Mater Private, St. James’s, Beaumont, The Bon Secours Health System, St. Lukes, The National Orthopaedic Hospital, The National Children’s Hospital and many others.

    He has presented guest lectures to students in the Department of Process Engineering at University College Cork, and also at St.James’s Hospital in Dublin.

    His company, Open Innovation Partners, is part of a European Consortium, ‘BioApp-Biodesign For Health’ which aims to integrate innovation into the undergraduate curriculum across Europe through formulated design methodologies leading to accelerated application of biomedical technologies in the clinical setting.

    He is also co-founder of Metabolomic Diagnostics, a molecular diagnostics research company that has developed a risk stratification and predictive screening test for preeclampsia. As director with responsibility for regulatory affairs, Diarmuid has overseen the implementation of a Quality Management System which has been accredited to ISO:13485 standard.

    Diarmuid is a regular speaker at major Business conferences globally. He maintains contact with the FDA at a high level and presented at the EU-US Standardisation Conference in the RCSI in February 2013, and most recently at the SMEST Conference in Brussels, Belgium. In 2014 he was put forward as an Irish subject matter expert by the NSAI to sit on ISO TC 276 which is currently drafting standards for biorepositories and bioprocessing. He also sits on the International Biomarkers Consortium for Preeclampsia with representatives from the FDA, Roche, Beckman Coulter, Siemens Healthineers and others. Finally, as an Enterprise Ireland Mentor he advises many EI startups particularly those involved in the life sciences sector.



    Title: Large scale human genetics application in genomic medicine and drug discovery

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