Leslie Dowling
Regulatory Rapporteur Editor-in-chief
Leslie has been a regulatory professional since 1997, working mostly as a regulatory consultant/team leader in the CRO/consultancy space, although she has also worked in pharma and a medical device company. She has a special interest in early clinical phase development, and has been Editor in Chief of Regulatory Rapporteur since 2011.
Meeting ReportHM7: Regulatory progress in delivering on the promise of ATMPs
Tomáš Borán introduced the presenters, co-chair and panellists for this session, discussing the regulatory progress in delivering on the promise of advanced therapy medicinal products (ATMPS)
Meeting ReportHM5: Reliance, worksharing and recognition as 21st century regulatory tools
Francesca Buttigieg introduced this session on reliance, worksharing and recognition as 21st century regulatory tools. Murray Lumpkin gave the opening presentation, giving a strong justification for the use of work-sharing and reliance as a use of best practice by all regulatory authorities (RAs), not just the smaller, less known RAs….