RAPS Convergence 2026: Preparing Your Proposal

Before You Begin

This web page is designed to help you prepare your proposal details 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.

Use this guide as a starting point to gather the key information you’ll need for your submission. Once all your data is confirmed, please submit your proposal through the submission portal - it will take approximately 15–20 minutes to complete the tasks in the portal. You may save and return to your submission along the way before the deadline.

Use of this document is optional, but all submissions must be submitted through the online portal by the stated deadline. For questions, contact: convergence@raps.org.

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Important Dates

• 7 January 2026 at 11:59 PM EST: Deadline to submit all proposals (no extensions will be granted)
• March 2026: Proposal notifications sent

Click here to view the 2026 Submission Guidelines

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Overview of Submission Types, Tracks & Topics

You will need to select one of the three submission types. Each type includes various tracks and topics aligned with the conference theme, enabling attendees to select subjects that suit their professional interests or needs.

Submission Types

Submission Type	Session Length	Day of Conference	Description	Total Presenters
Preconference Workshop	1 Full Day or 2 Full Days	Monday or Tuesday	Preconference workshops are full-day sessions (you may propose a 1- or 2-day format) held on one of the two days prior to the start of the main conference. Workshops may include up to six presenters and should provide an in-depth, hands-on exploration of key regulatory topics.	6 presenters (max)
Concurrent Session	60 Minutes or 75 Minutes	Wednesday or Thursday	Concurrent sessions (breakouts) are engaging, focused discussions on key regulatory topics and may include up to four presenters. Sessions may be 60 or 75 minutes in length, as determined by the planning committee.	4 presenters (max)
Solutions Circle	30 Minutes	Wednesday or Thursday	Solutions Circles are 30-minute fast-paced, interactive discussions facilitated by one presenter in a dedicated area of the exhibit hall during the main conference. These sessions are informal and do not require slide presentations.	1 facilitator (max)

Tracks & Topics

Tracks and topics vary by the submission type you select. See below for an example of tracks and topics for each type.

Submission Type: Preconference Workshop

You will select from one of the following tracks:

• Pharmaceuticals (includes Biologics and Drugs)
• In Vitro Diagnostics
• Medical Devices
• Other (you will have the option to explain)

Submission Type: Concurrent Session / Main Conference

You will select from one of the following tracks and one of its corresponding topics:

Track: Broad Interest
(Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

• Other
• Sustainability

Track: Medical Devices or In Vitro Diagnostics
(You will have the opportunity to specify medical device or in vitro diagnostic)

• Combination Products
• Digital Health such as Artificial Intelligence (AI) / Machine Learning (ML), SaMD, Wearable Devices, Remote Patient Monitoring
• Emerging Standard Developments & Horizontal Regulations (Med Device & IVD Standards, QMS Standards, etc.)
• EU MDR Transition & Recertification Deadlines
• Global Supply Chain Compliance (UDI, EUDAMED, Other Emerging Regulations)
• Health Equity Initiatives
• International Convergence & Harmonization / IMDRF / AHWP / GHWP / MDSAP
• IVD Sub-types: Companion Diagnostics, Near Patient Testing, LDTs, Gene Panels, etc.
• Other
• Pre- and Post-Market Clinical Evidence / Data for Medical Devices & IVDs
• Recent Developments in Legislative / Policy Environment
• Recent Developments in Post-Market Surveillance & Vigilance
• Recent Developments in Pre-market Submissions
• Regulatory Intelligence
• Serving Unmet Medical Needs: Pediatric Development, Women’s Health, Rare & Orphan Conditions

Track: Pharmaceuticals (includes Biologics and Drugs)

• Accelerating Drug Development: Expedited Pathways, Breakthrough Designations, Collaborative Review Programs, & Regulatory Innovation
• Advanced Therapy Platforms: Cell & Gene Therapy, ATMPs, & Next-Generation Biologics
• Artificial Intelligence (AI) & Digital Technologies in Drug Development & Regulatory Affairs
• Clinical Trial Innovation: Decentralized Trials, Master Protocols, Real World Evidence, Diversity Initiatives, & Evidence Generation Planning
• CMC, Quality Systems, Manufacturing Innovation, & Supply Chain Resilience
• Complex Products: Combination Products, Companion Diagnostics, & Novel Modalities
• Development & Approval of Generic Drugs & Biosimilars
• Digital Transformation and Regulatory Submissions
• Global Harmonization & International Regulatory Cooperation
• Nonclinical Innovation, New Approach Methodologies, & Animal Testing Reduction
• Patient-Centric Regulatory Approaches & Expanded Access Programs
• Pharmacovigilance, Post-Market Surveillance, & Risk Management
• Public Health Preparedness, Emergency Use Authorization, Vaccines, Emerging Infectious Diseases
• Recent Developments in Regional Legislative/Policy Environment
• Regulatory Communication: Transparency, Public Assessment Reports, Labelling, & Stakeholder Information
• Regulatory Intelligence
• Serving Unmet Medical Needs: Pediatric Development, Women’s Health, Rare & Orphan Conditions
• Translational Science, Biomarkers, & Companion Diagnostics

Track: Skill Building

• Career Transitions
• Financial Literacy
• Leadership Skills (e.g. emotional intelligence, body language, negotiation skills, communication skills, etc.)
• Leveraging Artificial Intelligence (AI) and Other Innovative Business Productivity Tools
• Other
• Preparing for Health Authority Interactions (meetings/scientific advice, advisory committees)
• Regulatory Affairs Skill Building for eQMS & Data Management
• Regulatory Strategy / Global Regulatory Planning
• Regulatory Team Management & Personnel Development

Submission Type: Solutions Circle

You will select from one of the following tracks for your Solutions Circle:

• Pharmaceuticals (includes Biologics and Drugs)
• In Vitro Diagnostics
• Medical Devices
• Other (you will have the option to explain)

Proposal Details

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.

Proposal Title

Up to 15 words / 200-character limit. Your title should briefly describe the focus and nature of your presentation.

Abstract Description (100–300 words)

Describe how participants will benefit from attending this workshop. (Hint: Don’t focus only on what they will learn, but how they can apply what they will learn to their job and career.)

Learning Objectives

Provide 2–3 learning objectives that clearly explain what participants should be able to do after attending your workshop.

Learning Objective #1

Learning Objective #2

Learning Objective #3

Geographic Coverage

Select the primary geographic region the proposal will cover. (While proposals may address more than one area, you must select one that is the best fit):

• US
• Canada
• Europe
• Asia
• Latin America
• Oceania
• Middle East
• Africa
• Other

Instructional Format

Select the format that best suits your proposal.
(This option does not apply to Preconference Workshops or Solutions Circles.)

• Panel: A panel discussion features multiple experts sharing their knowledge on a specific topic in front of an audience.
• Presentation: A traditional session where one or more speakers deliver prepared remarks or insights.
• Case Study: A focused session examining a real-world example, project, or experience with lessons learned.
• Undecided: Format to be determined; submitters will confirm the most appropriate style later with members of the planning committee.

Presenters List

Depending on the submission type (preconference workshop proposal, concurrent session or Solutions Circle), a maximum number of presenters may be listed.

RAPS Presenter Policies Permit the Following:

• Preconference Workshops: Up to 6 presenters may be listed in your proposal.
• Concurrent Sessions: Up to 4 presenters may be listed in your proposal.
• Solutions Circles: Up to 1 facilitator (presenter) may be listed in your proposal.

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 at RAPS Convergence.

Presenter Details

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.

• First and Last Name*
• Email*
• Phone*
• Address*
• Professional Job Title*
• Name of Company / Institution / Organization*
• Brief Professional Biography* (up to 300 words)
• Organization Type*
• Presentation History* (Has this individual presented at other educational conferences or at Convergence within the past three years? If yes, list the event name, year, and topic. If no, type “No.”)
• RAPS Membership Status (Is this presenter a current RAPS member? Membership is not required to submit or be listed on a proposal.)
• Presenter Awareness Confirmation* (If you are entering information on behalf of a presenter, please confirm that they are aware of and have agreed to be recommended for this topic/proposal.)

Regulatory Competency Framework & Learning Levels

To help ensure a comprehensive educational experience for Convergence attendees, 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
• Emphasize implementation/application of the topic rather than a general overview

RAPS Regulatory Competency Framework Resources

• Download: Regulatory Competency Framework PDF
• Download: Regulatory Competency Framework Addendum (2022) PDF

Regulatory Competency Framework Levels

You will select the appropriate level. Please refer to the framework documents for guidance.

Domain And Knowledge Areas

The Regulatory Competency Framework organizes competencies into seven domains with respective knowledge areas:

Core Foundational Domains	Leadership Ethics
Cross-Functional Domains	Business Acumen Scientific & Health Concepts
Technical Domains	Product Development & Registration Regulatory Framework & Strategy Postapproval / Postmarket

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.

The Regulatory Competency Framework organizes competencies into seven domains. Review the provided examples in the downloadable PDFs above to identify where your content aligns with these domains and knowledge areas, then select from the dropdown in the online submission form.