Navigating the New TMF Regulatory Landscape: Preparing for the Future

Presentation given by Paul Fenton, President & CEO and Christina Mantzioros, Clinical Solutions Specialist at Montrium

In recent years, regulatory authorities around the globe have been busy working on and releasing new guidance and regulations to guide our industry in its current state. While we often have to wait patiently for new guidance to be released for the life sciences, 2017 saw a change in pace, with a wealth of new updates coming from regulatory authorities and standards organizations.

Montrium’s Paul Fenton and Christina Mantzioros will present the regulatory changes announced in 2017 that will impact trial master files in 2018 and provide a practical outlook on how to apply these new updates in 2018 and beyond.

Paul Fenton holds a degree in management from London Metropolitan University as well as an MBA in Technology Management from the Université du Québec à Montréal. Paul has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005. He has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards as well as in the integration of systems and processes for clinical trials. He is a regular speaker at industry events and is actively involved in several projects for the development of clinical research standards and platforms.

With a mandate to bridge the gap between clinical research, technical development, and business applications, Christina plays a vital role as Montrium’s Clinical Solutions Specialist. With over five years’ experience working in project management roles in clinical operations departments at both Academic and Clinical Research Organizations, Christina provides the Montrium team with essential insights into how clinical professionals use our products and platforms. Highly engaged with the Life Science industry and an expert on clinical and regulatory best practices, Christina regularly contributes to industry conferences, company webinars as well as the Montrium blog.


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