--- title: Webinar - Navigating the New TMF Regulatory Landscape description: Join us for our upcoming webinar where we present our take on the year in TMF and the most crucial information that you will need moving forward. image: https://info.montrium.com/hubfs/webinar-cta-tmf-regulatory-landscape.jpg --- [![montrium-logo](https://info.montrium.com/hs-fs/hubfs/montrium-2023/images/header/montrium-logo.png?width=130&height=23&name=montrium-logo.png "montrium-logo")](https://www.montrium.com) ##### ON-DEMAND WEBINAR # Navigating the New TMF Regulatory Landscape ![profile5](https://info.montrium.com/hs-fs/hubfs/montrium-2023/images/webinar/profile5.webp?width=296&height=296&name=profile5.webp) ##### Christina Mantzioros Clinical Solutions Specialist Montrium [View Profile](https://www.montrium.com/about/our-team) ![Paul round](https://info.montrium.com/hs-fs/hubfs/1%20-%20Images/Landing%20Page%20Images/Landing%20page%20images/Paul%20round.png?width=300&height=300&name=Paul%20round.png) ##### Paul Fenton President & CEO Montrium [View Profile](https://www.montrium.com/about/our-team) ### Learn how the regulatory changes will affect your TMF management process! While we often have to wait patiently for regulators to release new regulations and guidance for the life sciences, in recent years we've seen a dramatic change in pace, with a wealth of new updates coming from regulatory authorities and standards organizations. In our webinar titled "Navigating the New TMF Regulatory Landscape" Montrium’s Paul Fenton and Christina Mantzioros present the regulatory changes announced in 2018 that will impact trial master files and providing a practical outlook on how to apply them moving forward. **The 50 minute webinar will focus on:** - The changing regulatory landscape - How eTMF systems are shaping the regulations - Updates from the MHRA Symposium - Overview of the recent EMA guidance - Before and after the GCP E6 (R2) update - 21 CFR Part 11 for Trial Master File (recent update) - Practical considerations for 2018 - The "State of the Union" of the TMF Landscape - And much more... ## Get access to this great on-demand webinar by following the form below ## Get our best content delivered straight to your inbox [![Montrium\_White\_Logo\_smaller](https://info.montrium.com/hs-fs/hubfs/montrium-2023/images/logo/Montrium_White_Logo_smaller.png?width=130&height=32&name=Montrium_White_Logo_smaller.png "Montrium_White_Logo_smaller")](https://www.montrium.com/) #### Montrium eTMF - [eTMF Connect](https://www.montrium.com/etmf-connect) - [eTMF Connect features](https://www.montrium.com/etmf-connect-features) #### Montrium RIM - [RegDocs Connect](https://www.montrium.com/regdocs-connect) - [RegDocs Connect features](https://www.montrium.com/regdocs-connect-features) #### Montrium QMS - [Quality Connect](https://www.montrium.com/quality-connect) - [Quality Connect features](https://www.montrium.com/quality-management-software-features) #### Platform overview - [Platform overview](https://www.montrium.com/platform-overview) - [Pricing](https://www.montrium.com/pricing) - [Montrium FAQ](https://www.montrium.com/faq#anchorFaq) - [Trust center](https://www.montrium.com/trust-center) #### Resources - [Demo center](https://www.montrium.com/demo-center) - [Resource center](https://www.montrium.com/resource-center) - [Podcasts](https://www.montrium.com/podcasts) - [Webinars](https://www.montrium.com/webinars) - [Blog](https://blog.montrum.com/blog) #### Montrium by industry - [Non-profit](https://www.montrium.com/montrium-by-industry/non-profit) - [Medical device](https://www.montrium.com/montrium-by-industry/medical-devices) - [CRO](https://www.montrium.com/montrium-by-industry/cros) - [Pharma/Biotech](https://www.montrium.com/montrium-by-industry/pharma-biotech) #### Adobe Acrobat Validation - [Adobe Acrobat validation services](https://www.montrium.com/adobe-sign-validation-services) - [Free Adobe Acrobat validation pack](https://www.montrium.com/adobe-sign-validation-pack) #### Montrium by team - [Clinical operations](https://www.montrium.com/clinical-operations) - [Regulatory affairs](https://www.montrium.com/regulatory-affairs) - [Quality and compliance](https://www.montrium.com/quality-and-compliance) - [IT & security](https://www.montrium.com/it-and-security) #### Company - [About](https://www.montrium.com/about) - [Newsroom](https://www.montrium.com/newsroom) - [Events](https://www.montrium.com/events) #### Contacts 507 Place d'Armes,Suite 1500 Montreal, QC H2Y 2W8,Canada +1.514.223.9153  [info@montrium.com](mailto:info@montrium.com) Montrium Europe SPRL,Boulevard de Waterloo77 1000 Bruxelles, Belgium +32.2.808.3008 [info@montrium.com](mailto:info@montrium.com) #### Socials [Follow us on Facebook](https://twitter.com/Montrium) [Follow us on Instagram](https://www.facebook.com/Montrium/) [Follow us on Instagram](https://www.linkedin.com/company/montrium) Montrium Inc. All rights reserved, 2026 [Terms and Conditions](https://www.montrium.com/terms-conditions) [Privacy Legacy](https://www.montrium.com/privacy-policy) ```json { "@context" : "https://schema.org", "@id" : "https://info.montrium.com/navigating-new-tmf-regulatory-landscape/#breadcrumbs", "@type" : "BreadcrumbList", "itemListElement" : [ { "@type" : "ListItem", "item" : "https://www.montrium.com", "name" : "Home", "position" : 1 }, { "@type" : "ListItem", "item" : "https://blog.montrium.com/blog", "name" : "Montrium Blog", "position" : 2 }, { "@type" : "ListItem", "item" : "https://info.montrium.com/navigating-new-tmf-regulatory-landscape", "name" : "Webinar - Navigating the New TMF Regulatory Landscape (eTMF Bootcamp)", "position" : 3 } ] } ``` ```json { "@context" : "https://schema.org", "@id" : "https://info.montrium.com/navigating-new-tmf-regulatory-landscape/#blogposting", "@type" : "BlogPosting", "about" : [ { "@type" : "Thing", "name" : "" } ], "articleSection" : "", "author" : { "@type" : "Person", "description" : "", "image" : { "@type" : "ImageObject", "url" : "" }, "jobTitle" : "", "name" : "", "sameAs" : [ "" ], "url" : "" }, "dateModified" : "2026-05-12T18:03:05-05:00", "datePublished" : "2017-11-06T16:04:05-05:00", "description" : "Join us for our upcoming webinar where we present our take on the year in TMF and the most crucial information that you will need moving forward.", "headline" : "Webinar - Navigating the New TMF Regulatory Landscape (eTMF Bootcamp)", "image" : { "@type" : "ImageObject", "height" : "0", "url" : "", "width" : "0" }, "inLanguage" : "en-US", "isPartOf" : { "@id" : "https://blog.montrium.com/blog/#blog", "@type" : "Blog" }, "keywords" : [ ], "mainEntityOfPage" : { "@id" : "https://info.montrium.com/navigating-new-tmf-regulatory-landscape", "@type" : "WebPage" }, "name" : "Webinar - Navigating the New TMF Regulatory Landscape (eTMF Bootcamp)", "publisher" : { "@id" : "https://company.montrium.com/#organization", "@type" : "Organization", "logo" : { "@type" : "ImageObject", "height" : 641, "url" : "https://cdn.prod.website-files.com/6384d2343a69e90062fc1181/697d0f2f1a3f5f635cde4595_Montrium%20Logo%20-%20Purple.png", "width" : 3689 }, "name" : "Montrium" }, "timeRequired" : "PT0M", "url" : "https://info.montrium.com/navigating-new-tmf-regulatory-landscape", "wordCount" : 0 } ```