Curriculum Vitae of Breffni Martin   Breffni Martin was educated at Cistercian College Roscrea and University College Dublin, where he graduated in Biology in 1983. He spent the next 20 years in the pharmaceutical industry in a variety of areas including the following:   US and international regulatory affairs Licensing FDA compliance and inspection Technology transfer Analytical science Auditing Validation Writing (scientific/regulatory/medical/French-English translation) Laboratory Information Systems (to support QC, pharm/tox, biological screening etc)   Professional Experience   Director CanReg (Europe) Ltd                                                                           Since January 2004   CanReg (Europe) is the European subsidiary of CanReg Inc , the largest regulatory services company in Canada. CanReg specialises in providing high-quality low-cost regulatory services for North America including the following: Clinical trial applications New Drug Applications/Submissions including the CTD Notifiable changes and variations Quality and compliance services Regulatory services Reimboursement Training     Director RegIntel Ltd                                                                                        2003 - Present Ireland Founded RegIntel Limited, an Irish-based consultancy specialising in regulatory intelligence and licensing     Director Product Development, Business Development IMS Health, IH Inc and Liquent Inc.                                                   1997 - 2002 Paris, France                                                                                          IDRAC is an on-line database of regulatory information covering the whole drug development lifecycle in over 30 countries. Breffni Martin managed content for the US and developed content for Japan, the UK, Ireland, Canada, Australia, Latin America, South East Asia, Scandinavia, Greece.   Most recently he created and launched the AdComm Bulletin, which covers human drug advisory committee meetings run by FDA and has been well received by industry.     Freelance Consultant Paris, France, and USA                                                                        1995 - 1997   Clients included: IBM Medical (telemedicine) Notocord SA (pharm/tox software) Biologie & Industrie (medical writing) Servier (medical writing) Pfizer (auditing)   Regulatory, Compliance Manager; Analytical Services Director GSK Singapore                                                                                             1992 - 1995   Part of a multi-disciplinary team responsible for commissioning a $300 million multi-purpose manufacturing facility for supplying the US market, with specific responsibility for regulatory affairs, all analytical matters on site, validation (systems, software, analytical methodology), hiring and training a staff of more than 40 scientists.   API's for Imigran, Zofran, and Severent successfully commissioned for US and Japanese markets.     Medical and Promotional Writer Hong Kong and SE Asia                                                                       1991   Clients included: Medica Excerpta, HK Trade Development Council, Asian Sources (medical and promotional writing) Concordia - paper recycling (completed an environmental impact assessment report)     Pharmaceutical Development Manager Laboratoire Guerbet                                                                             1986 - 1990 Aulnay sous Bois, France   Developed processes for manufacture of injectible contrast media including Hexabrix, Dotarem, Optiray, Ferridex IV, Gastromark using several innovative technologies Took a lead role in licencing and technology transfer projects with Mallinkrodt, Byk Guilden and Advance Magentics.     Development Chemist Fermenta, BMS                                                                                    1983 - 1986 Ireland and France Process development and technology transfer of API’s from Ireland to France and France to Italy and Sweden. Commissioned aqueous waste treatment facility. Production Technician Bayer Levercusen, Germany                                                                           1982 Production technician in manufacture of Asprin.   Drug Information Association   Breffni Martin is a long-standing member of the Drug Information Association, the pharmaceutical industry’s largest professional association with over 25,000 members worldwide: Member of DIA Advisory Council of Europe (European steering committee) Member of the International Core Committee of the Validation SIAC Program Chairperson for eClinical, Clinical Data Management, IT and Validation multi-track conference in Prague November 2005 Speaker and Session Chair several meetings Various publications in progress.   In his spare time he is interested in wildlife photography.