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Regulatory Leaders: Become A Speaker In Montreal!

RAPS Convergence 2023

3 – 5 October 2023

Preconference Workshops

2 – 3 October 2023

 

The 2023 Convergence Planning Committee invites you to propose an in-person session or workshop for RAPS Convergence. If accepted, you will be expected to travel to Montreal to present.

Submission Cycle: 4 January – 6 February 2023 at 11:59 PM EST
Submit Now »

RAPS Convergence is the largest and most well-recognized gathering of regulatory professionals, scientists, and innovators globally. Convergence brings together representatives from industry, the regulatory realm, the research arena, academia, and clinical organizations that are directly involved in managing the regulatory process while aligning science, regulation, and business strategy.

Proposals are blinded and peer-reviewed for quality, educational content, logical presentationpresentation, and ramifications for the healthcare-regulatory community.

The RAPS Convergence Planning Committee reserves the right to request modifications, combine proposals and not automatically accept all suggested speakers. During the submission process, you must indicate your willingness to partake in a combined session if the committee decides that your proposal would work well with another.

2023 Categories & Topics

  • Accelerating drug development and approval through pilot programs and initiatives
  • Advertising & Promotion and Labeling
  • Biosimilars
  • Clinical Trial Design and Alternative Data Sources (e.g., diversity, precision medicine, patient-focused drug development, drug development tools, pediatric trials, 505(b)(2)s, N-1 trials)
  • CMC & Quality & Supply Chain
  • Combination Products
  • Expanded Access/Compassionate Use/Right-to-Try
  • Expedited Designations and Pathways & Pilot Programs
  • Generic Drug Development and Approval (e.g., complex generics, off-patent drugs w/no competition)
  • Harmonization Efforts (e.g., ICH, APEC, LATAM)
  • Incorporating the Patient Perspective into the Regulatory Process
  • Innovative Technologies and Platforms (e.g., RMAT, ATMPs/cell and gene therapies)
  • Orphan Drugs and Rare Diseases
  • OTCs (e.g., monograph reform, novel switches)
  • Pharmacovigilance and Safety Monitoring
  • Post-Approval and Lifecycle Activities
  • Recent Developments and Impact of Legislative/Policy Environment
  • Real-World Evidence to Support Regulatory Decision-Making
  • Vaccines
  • Career Transitions
  • Crisis Management
  • Ethical Behavior
  • Financial Literacy
  • Leadership Skills (e.g., emotional intelligence, body language, etc.)
  • Leveraging AI and Other Innovative Tools
  • Negotiation and Communication Skills
  • Other
  • Preparing for Health Authority Interactions (meetings/scientific advice, advisory committees)
  • Regulatory Intelligence
  • Regulatory Leadership
  • Regulatory Strategy/Global Regulatory Planning
During the submission process you can specify if your proposal is Medical Device or In Vitro Diagnostic specific.
Topics:
  • Advertising, Promotion and Labeling
  • Clinical Evaluation
  • Combination Products
  • Companion Diagnostics and Personalized Medicine
  • DeNovo Process
  • Digital Health/Software as a Medical Device/Mobile Apps and e-Labeling/Wearables
  • Emerging Standard Developments
  • Global Supply Chain Compliance (track and trace, UDI, recent changes, etc.)
  • Harmonization/ IMDRF/AHWP
  • Human Factors Studies/Usability Engineering
  • Incorporating the Patient Perspective into the Regulatory Process
  • Medical Device Single Audit Program (MDSAP)
  • Modeling and Simulation
  • Pediatric Medical Devices
  • Performance Evaluation and Clinical Evidence
  • Postmarketing Clinical Follow-Up (PMCF)
  • Preclinical Studies
  • Real-World Evidence to Support Regulatory Decision-Making
  • Recalls
  • Recent Developments in Legislative/Policy Environment
  • Recent Developments in 510(k)
  • Recent Developments in IVDs
  • Recent Developments in LDTs
  • Regulatory Framework to Support Innovation
  • Risk Management
  • Safety/Adverse Event Reporting
 

How To Submit

Submit proposals at the RAPS Convergence 2023 proposal submission page.

 

About the submission process

  • An account is required to submit a proposal. When creating an account, you must provide a valid e-mail address, as RAPS will rely exclusively on email communications related to proposal submission, disposition, and presentation.
  • Submit proposals online only. Submissions by email, fax, or mail will not be accepted.
  • You may save your progress at any point and return to your saved submission until the deadline date, Monday, 6 February 2023, 11:59 pm Eastern Standard Time (EST).
  • Individuals may submit up to four proposals. RAPS will not select more than two submissions from an individual to avoid speaker scheduling conflicts.
  • Please allow several days before the proposal submission deadline to resolve questions or problems with the online submission process.
  • Failure to follow online submission procedures may result in the rejection of the proposal.
  • Late and/or incomplete submissions will not be accepted.
  • The RAPS Convergence Planning Committee reserves the right to request modifications, combine proposals and may not accept all suggested speakers.
 

Proposal Template Tool

To assist in planning, download the proposal template to work on your submission offline. When ready to submit, use the above Call for Proposal link to complete and submit your proposal. 

Download Template
 

Important Dates

4 January 2023 Proposal submission opens.
6 February 2023 at 11:59 pm, EST Proposal submissions deadline. No extensions will be granted. 
February - March 2023 Convergence Planning Committee review process.
April 2023 Notifications will go out to all who submitted a complete abstract. 
2 – 5 October 2023 RAPS Convergence 2023, Montreal, QC
 

Other Information

If your session proposal is accepted:

  • Presenters will receive complimentary registration for the conference.
  • Preconference workshops are available as an add-on purchase option. RAPS does not provide honorarium.

If your preconference workshop abstract is accepted:

  • Preconference workshop presenters will receive complimentary registration for  main conference.
  • Registration for other Preconference workshops are available as an add-on purchase option.
  • Stipends are available for workshop presenters who do not receive assistance from their employers or other sources to attend Convergence.