2021 Call for Abstracts

 

Have an interesting topic to discuss?
Discovered an innovative process that you want others to learn?
Want to enhance and expand the regulatory industry?

 
Share your knowledge with peers at RAPS Convergence 2021 (11-14 September 2021).

 
The Convergence Planning Committee welcomes proposals for RAPS Convergence 2021.

RAPS Convergence 2021 submissions are peer-reviewed for quality, educational content, logical presentation, and impact on the global healthcare regulatory community. Accepted submissions are scheduled as oral presentations in a variety of formats (i.e. panel, debate, solution circle) based on anticipated interest by attendees. By submitting an abstract, you agree that if your submission is accepted, it will be presented as described.
 
Submission Deadline: Monday, 22 February 2021 at 11:59 pm EST
 

2021 Call for Abstracts Topics

The RAPS Convergence Planning Committee has identified the following topics for abstract submission.

  • Innovative Technologies and Platforms (e.g., RMAT, ATMPs/Cell and Gene Therapies)
  • Artificial Intelligence
  • Biosimilars
  • CMC
  • Use of Real-World Evidence to Support Regulatory Decision-Making for Biopharmaceuticals
  • Expedited Designations and Pathways
  • Orphan Drugs and Rare Diseases
  • Expanded Access/Compassionate Use/Right-to-Try
  • Recent Developments and Impact of the US Legislative/Policy Environment
  • Recent Developments and Impact of the EU Legislative/Policy Environment
  • Recent Legislative/Policy Developments in Other Markets
  • Clinical Trial Design and Alternative Data Sources (e.g. precision medicine, patient focused drug development, drug development tools, pediatric trials, 505(b)(2)s, N-1 trials))
  • Harmonization Efforts (e.g. ICH, APEC, LATAM)
  • Advertising and Promotion
  • Labeling
  • Generic Drug Development and Approval (e.g. complex generics, off patent drugs w/no competition))
  • OTCs (e.g. monograph reform, novel switches)
  • Data Transparency
  • Hot Topics in Vaccines
  • Hot Topics – Other (e.g. consortiums, preparing for PDUFA VII)
  • Combination Topics
  • Pharmacovigilance, Risk Evaluation and Mitigation Strategies
  • Accelerating Drug Development through Pilot Programs and Initiatives
  • Other
  • Artificial Intelligence
  • Cybersecurity
  • Medical Device Single Audit Program (MDSAP)
  • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  • Recent Developments in US Regulations
  • Recent Developments in 510(k)
  • DeNovo Process
  • Recent Developments in EU Regulations
  • Recent Developments in Other Geographical Regions Beyond EU and US (e.g. Asia Pacific, Latin America, China, Canada, etc.)
  • Emerging Standard Developments
  • Human Factors Studies/Usability Engineering
  • Pediatric Medical Devices
  • Risk Management
  • Preclinical Studies
  • Clinical Evaluation
  • Postmarketing Clinical Follow-Up (PMCF)
  • Harmonization/ IMDRF/AHWP
  • Regulatory Framework to Support Innovation
  • Digital Health/Software as a Medical Device/Mobile Apps and e-Labeling/Wearables
  • Modeling and Simulation
  • Advertising, Promotion and Labeling
  • Inspections and Warning Letters
  • Recalls
  • Safety/Adverse Event Reporting
  • Global Supply Chain Compliance (track and trace, UDI, recent changes, etc.)
  • Combination Topics
  • Other
  • Recent Developments in EU Regulations (MDR and IVDR)
  • Recent Developments in Other Geographical Regions Beyond EU and US (e.g. Asia Pacific, Latin America, China, Canada, etc.)
  • Emerging Standard Developments
  • Performance Evaluation and Clinical Evidence
  • Personalized Medicine
  • Companion Diagnostics
  • Recent Developments in IVDs
  • Recent Developments in LDTs
  • Other
  • Regulatory Strategy/Global Regulatory Planning
  • Incorporating the Patient Perspective into the Regulatory Process
  • Regulatory Policy and Trends
  • Leadership Skills (e.g. emotional intelligence, body language, etc.)
  • Negotiation and Communication Skills
  • Crisis Management
  • Career Development and Career Changes
  • Preparing for Health Authority Interactions (meetings/scientific advice, advisory committees)
  • Leveraging AI and Other Innovative Tools
  • Other
 

Preconference Workshops


Submit a preconference workshop idea for deep-dive intensive learning. This is a unique opportunity to incorporate different learning and instruction tactics to really help attendees get a handle on your topic of choice. Workshops can be one or two days. Submit an abstract and include your detailed class agenda.
 
Topics:
  • Biologics
  • Medical Devices
  • Drugs
  • In Vitro Diagnostics
  • Other
 

How to Submit:


To submit a proposal, visit the RAPS Convergence Call for Abstracts
 
Important things to remember about the submission process:
  • Submitting an abstract will require an account. When creating an account, you must provide a valid e-mail address, as RAPS will rely exclusively on email communications related to  abstract submission, disposition, and presentation.
  • All abstracts must be submitted online; abstracts submitted 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 on Monday, 22 February 2021 at 11:59 pm US EST.
  • Although you may submit multiple proposed sessions, RAPS will not select more than two submissions from an individual to avoid speaker scheduling conflicts.
  • Please allow several days before the submission deadline to resolve questions or problems with the online submission process.
  • Failure to follow online submission procedures may result in rejection of the abstract.
  • Late and/or incomplete submissions will not be accepted.
  • The RAPS Convergence Planning Committee reserves the right to request modifications, combine abstracts and may not accept all suggested speakers.

Schedule

11 January – 22 February 2021, 11:59 pm, EST Submission deadline for abstracts. No extensions will be granted.
April 2021 Notifications will go out to all who submitted a complete abstract (delete Acceptance/Rejection.
11-14 September 2021 RAPS Convergence 2021

If your session abstract 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 to cover expenses for presentations.
 
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.