This web page is designed to help you gather and prepare important proposal details for the Regulatory Intelligence Conference Europe and AI in Regulatory Conference before submitting them through the online portal. For convenience, you may save a copy of this page or copy and paste its contents into your own editable document.
Once all your data is confirmed, please submit your proposal through the submission portal. It will take approximately 15–20 minutes to complete required tasks in the submission portal.
Use of this document is OPTIONAL, but all submissions must be submitted through the online portal by the stated deadline. For questions, contact: europeevents@raps.org.
You will first be asked to select the conference for which you are submitting, followed by the applicable submission type. Each submission type includes specific tracks and topics aligned with the conference theme, allowing you to choose the option that best fits your content and intended audience.
| Submission Type | Description | Total Presenters |
|---|---|---|
| Concurrent Session Proposal | Submit a concurrent session proposal for the Regulatory Intelligence Conference Europe. Proposals should focus on the regulatory intelligence function across the medical device, IVD, and/or pharmaceutical industries, and should address such topics as challenges/solutions for supporting regulatory intelligence, team development, KPIs, AI, and digital technologies. | 4 presenters (max) |
| Submission Type | Description | Total Presenters |
|---|---|---|
| Preconference Workshop Proposal | Submit a preconference workshop proposal for the AI in Regulatory Conference. The topic for the preconference workshop is: "The Roadmap to Implementing AI Tools at Your Organization." Your proposal must reflect this topic. | 6 presenters (max) |
| Concurrent Session Proposal | Submit a concurrent session proposal for the AI in Regulatory Conference. Proposals should focus on med tech processes broadly and highlight real-world uses across regulatory workflows. Topic ideas include, but are not limited to: clinical, risk management, post-market, usability, automation, prompt writing, simulated use, translation, compliance check/gap analysis, in-house use cases, risk analyses, business case, RIM, product lifecycle, technical documentation submission, international submissions, TD compilation, IVD performance evaluation, AI tools for notified bodies, and change management. | 4 presenters (max) |
Tracks and topics vary by the conference and submission type you select in the proposal system. You will only be shown the track and topic options relevant to the conference you choose. The examples below are provided for reference to illustrate how tracks, topics, and sub-topics may be structured.
You will indicate the most appropriate track and topics from the list below.
| Track | Topic | Sub-Topic |
|---|---|---|
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There is one preconference workshop at the AI in Regulatory Conference. The committee is accepting workshop proposals on the topic of: The Roadmap to Implementing AI Tools at Your Organization.
We are looking for a proposal that will share both a holistic view (e.g. how to identify use cases to use AI) and also have time for specific hands-on examples (e.g. how to use AI for particular tasks or issues, what is the technical implementation, the methodology used, and/or how to approach/utilize existing tools) that are appropriate for a workshop setting.
In an open text field area, you will need to indicate where your proposal's topic best aligns. Proposals should focus on med tech processes generally. We’d like to bring real-world uses into the conference and share what is happening in all regulatory workflows. Any aspect of the workflow will be considered. Topic ideas include but are not limited to: clinical, risk management, post-market, usability, automation, prompt writing, simulated use, translation, compliance check/gap analysis, in-house use cases, risk analyses, business case, RIM, product lifecycle, TD submission, international submissions, TD compilation, IVD performance evaluation, AI tools for notified bodies, and change management
Once you have selected your proposal type, track and topic (if applicable), you will then submit your proposal’s details. Depending on the type selected, you will need to provide specific information. The items below highlight some of the common details you’ll be asked to provide.
In addition to the above items, you are required to include a workshop agenda that follows RAPS’ standard structure. While you have the flexibility to design an agenda that aligns with the needs of your workshop, you must adhere to the fixed agenda items set forth by RAPS. This includes the daily start and end times plus breaks and meals. Here is a sample agenda as a reference. RAPS’ agenda items (shown in blue below) must be reflected in your agenda.
| 7:30 – 8:30 AM | Breakfast for Preconference Workshop Attendees |
| 8:30 – 10:30 AM | Your Agenda Items |
| 10:30 – 11:30 AM | Refreshment Break for Preconference Workshop Attendees |
| 11:30 AM – 12:30 PM | Your Agenda Items |
| 12:30 – 13:30 PM | Lunch for Preconference Workshop Attendees |
| 13:30 – 15:00 PM | Your Agenda Items |
| 15:00 – 15:15 PM | Break for Preconference Workshop Attendees |
| 15:15 – 16:00 PM | Your Agenda Items |
| 16:00 PM | Adjourn (all workshops must adjourn for day) |
Each submission type (preconference workshop or concurrent session) has a maximum number of presenters.
If you are entering information on behalf of a presenter, you will be required to confirm that they are aware of and agree to be recommended for this topic. Only confirmed individuals may be listed on a proposal. Unconfirmed or “wish list” speakers are not permitted.
If your proposal is selected, you will have the opportunity to work with a member of the planning committee to review and discuss any potential speaker additions (including Health Authority presenters). Accepted presenters are expected to travel and present in-person in Barcelona.
As you review the presenter details required by submission type, please note that items marked with an asterisk (*) are mandatory in the submission system. Be sure to gather this information in advance to ensure a smooth submission process.
To help ensure a comprehensive educational experience for conference participants, you will need to indicate how your proposal aligns with the RAPS Regulatory Competency Framework. Preference will be given to proposals that are: designed for Advanced or Expert levels; clearly specify both a domain and knowledge area; and emphasize implementation/application of the topic rather than a general overview.
RAPS Regulatory Competency Framework Resources
You will select the appropriate level. Please refer to the framework documents for guidance.
The Regulatory Competency Framework organizes competencies into seven domains with respective knowledge areas. Please refer to the framework documents for guidance in identifying where your content aligns within these domains and knowledge areas. You will need to provide the most appropriate option by selecting from a dropdown menu in the online submission form.