Diarmuid Cahalane

Diarmuid Cahalane has been consulting 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 leading life science companies, including Pfizer, Schering Plough, and Glaxo Smithkline. 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 Nellcor Puritan Bennett. 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. Diarmuid has also successfully provided accreditation services to hospitals enabling them to get their pathology laboratories accredited to ISO15189 Quality Standards. Hospital clients included 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. Funded by the European Union, the project is led by University College Cork, in conjunction with Universities in the Netherlands, Belgium, and Hungary. Diarmuid is a regular speaker at major Business conferences including the European Compliance Academy in Germany and validation conferences in Puerto Rico and the US. He maintains contact with the FDA at a high level and recently visited Washington DC to discuss innovative new theranostics concepts with the FDA, Patient Advocacy Groups and others. He spoke at the International Critical Markers Of Disease (CMOD) Conference in Dublin Castle in May 2012, the EU-US Standardisation Conference in the RCSI in February of this year, and most recently at the SMEST Conference in Brussels, Belgium.