TMF Week 2024 On-Demand

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Submission guidelines

We have launched a call for speaker abstracts for our 6th annual TMF Week conference, which will be taking place the week of June 9th, 2025. As always, we aim to create the best agenda of TMF education and value-driven content for all, with a special focus this year on how we deliver that content. 

New for 2025: Exclusive FDA Focus Day
We're excited to introduce an exclusive FDA Focus Day on June 9th, dedicated to regulatory activities and insights from experienced professionals. This special day is designed to provide attendees with a broader understanding of the FDA's role in clinical trials, compliance, and the evolving regulatory landscape.

If you have expertise in FDA-related activities and are passionate about sharing your knowledge, we encourage you to submit an abstract and be part of this impactful event.

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Below, you'll find a list of potential topics and areas that we're looking for speakers to address, as well as some ideas for session formats that can help keep our event engaging and fun. Please note that we accept speakers of all experience levels and welcome submissions which include co-presenters (more than 1 speaker). Here are some ideas for topic areas:

 

  • Risk-based TMF management
  • TMF and vendor management/oversight
  • Data privacy & security in TMF
  • TMF Metrics & KPIs
  • Managing joint inspections with CROs (sponsor perspective)
  • Impact of EU CTR on TMF
  • TMF storyboarding
  • TMF metrification
  • TMF & electronic forms
  • Implementing a QbD approach into your TMF process
  • ICH E6 R3 impact on TMF management
  • TMF Health monitoring
  • Investigator Site Files - Standardization
  • Dealing with notes to file
  • Building a TMF process with a small team
  • Streamlining study closeout and the TMF
  • TMF Reference Model V4 
  • ISF Reference Model updates
  • Digital TMF & Digital Data Flow
  • ICH M11
  • TMF 101 - Workshop for emerging biotechs
  • Leveraging AI in TMF beyond processing documentation
  • 360 degree inspection readiness
  • TMF archiving
  • Audit trail review
  • Trackers & logs in the TMF
  • The TMF Index
  • Managing multiple CROs from a TMF perspective
  • Selecting and implementing the right eTMF for you
  • eTMF migrations
  • The future of TMF
  • TMF Reference Model adaptation/implementation
  • TMF training & culture
  • TMF relevant regulatory guidance & standards
  • Bringing TMF in-house as a sponsor
  • TMF health scoring
  • The changing role of TMF'ers
  • Preparing for FDA TMF Inspections
  • FDA guidance on eTMF compliance
  • Risk-based monitoring and FDA expectations
  • AI and automation for FDA compliance
  • FDA expectations for vendor oversight
  • Lessons from FDA warning letters
  • Real-world evidence (RWE) in FDA submissions
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Experiment with different presentation formats

In addition to the topics suggested above, we've decided to provide some inspiration and ideas of different formats for your sessions this year. Feel free to use these as a guide when submitting your abstract. Generally, all sessions are structured around a 30-minute talk. However, please review below for other potential formats:

  • Presentations - Presentations are typically 30 mins in length which should include a minimum of 5 minutes for Q&A. Speakers are responsible for preparing a slide deck for presentation but please be mindful of the time you have.
  • Fireside chat - Fireside chats are conducted in an interview style and will focus more on the speakers experience in and around a specific topic and may touch on career trajectory. These are typically conducted over 30 minutes
  • Debate style - Debate style sessions are when we have a minimum of 2 speakers that discuss a number of pre-determined topics and debate points for and against. This session style has more audience participation.
  • Ask-me-anything - AMA's are a popular online trend within Reddit and other social media networks where experts or celebrities answer questions from their fans/audience. An AMA at TMF Week will consist of a series of pre-collected questions (some live) that will be put to an individual or panel on a series of TMF related topics.
  • Dragon's Den / Shark Tank - These sessions focus more on audience participating where individuals are selected to present an idea or concept to a panel of expert judges. These judges will ask questions and then select a winner.

 

Want to speak at TMF Week 2025?

Submit your proposal to speak today!