Experience

Citeline

• United States
• Information Services
• 200 - 300 Employee

• European regulatory affairs editor

  • Sep 1984 - Present



Business Intelligence and Information Systems

• Software Development

• European Regulatory Affairs Editor

  • Sep 1984 - Present

  London, United Kingdom Highly accredited journalist who explains medtech regulations in force and under development. Originator of news items, features, interviews, analysis and opinion pieces tracking the latest political and regulatory developments and assessing the "how, why, when, and what" impact on the sector. • Leading Informa reporting strategy on proposed EU regulations for medical devices and IVDs • Regulatory analysis of EU and global regulatory developments for medical device, IVD & drug/device… Show more Highly accredited journalist who explains medtech regulations in force and under development. Originator of news items, features, interviews, analysis and opinion pieces tracking the latest political and regulatory developments and assessing the "how, why, when, and what" impact on the sector. • Leading Informa reporting strategy on proposed EU regulations for medical devices and IVDs • Regulatory analysis of EU and global regulatory developments for medical device, IVD & drug/device combination products • Analysis of impact of Brexit on future regulatory outlook in the EU, UK and beyond • Frequently invited chair and moderator at meetings including EU MedTech Summits 2017 and 2018 • Frequent speaker and panellist, including RMD 2017, Berlin and RMD 2018, Brussels • Trained in radio and broadcast journalism • Contacts with regulators and notified bodies all over Europe • Over 30 years’ experience reporting and commenting on EU medtech regulations from their inception Show less



Maxwell Medtech Regulatory Consultancy

• Freelance Regulatory Consultant

  • Apr 2009 - Dec 2015

  London, UK Provision of medical technology regulatory services including: analysing how future medical device and IVD regulations are likely to impact clients/specific sectors; explaining how to comply with current medical devices and IVD regulations; regulatory strategy support services for medtech and pharma companies interested in drug/device combinations, including through training and moderating. Producing report and other written materials. Clients included: Multinationals and SME… Show more Provision of medical technology regulatory services including: analysing how future medical device and IVD regulations are likely to impact clients/specific sectors; explaining how to comply with current medical devices and IVD regulations; regulatory strategy support services for medtech and pharma companies interested in drug/device combinations, including through training and moderating. Producing report and other written materials. Clients included: Multinationals and SME medical device, IVD, pharmaceutical, drug/device combination product industries. Individual companies, trade associations, pharma and medical technology consultancies Conference organizers, speakers, regulators, investors, PR Show less



SFL Regulatory Affairs & Scientific Communication GmbH

• Switzerland
• Biotechnology Research
• 1 - 100 Employee

• Principal Consultant to

  • Apr 2009 - Jul 2013

  • Extensive experience in advising companies on regulatory pathways for devices, IVDs, drug/device combinations and companion diagnostics • Regular trainer at medtech and drug companies on drug and device regulatory issues • Particular knowledge of EU herbal medicinal and ATMP regulations • Active member of drug/device combination working group at EU trade association • Frequently invited speaker and chair at EU and US meetings on medtech and combination issues • Regular… Show more • Extensive experience in advising companies on regulatory pathways for devices, IVDs, drug/device combinations and companion diagnostics • Regular trainer at medtech and drug companies on drug and device regulatory issues • Particular knowledge of EU herbal medicinal and ATMP regulations • Active member of drug/device combination working group at EU trade association • Frequently invited speaker and chair at EU and US meetings on medtech and combination issues • Regular speaker and chair at medtech and combination product sessions organized by Drug Information Association (DIA) – Geneva and Chicago 2011; Copenhagen and Basel 2012; and Amsterdam 2013. Also involved in organization of combination product sessions. • Effective moderator of high-level European conferences and workshops on topics relating to medical technology, including on combination products and IVDs for industry and regulators • Member at founding of DIA Special Interest Area Community on Devices and Diagnostics Show less



PJB

• European regulatory affairs editor, Clinica

  • 1984 - 2004