Workshop: Interactive REMS Development, from Clinical Risks to Approved Risk Management

This workshop is an intensive sprint for participants through the entire lifecycle of US REMS programs! Work in small groups alongside some of the top leaders in the risk management field through an in-depth case study on how to develop REMS programs in the US. Participants will be assigned a hypothetical drug molecule, assess risks identified in clinical trials, and apply the REMS Logic Model framework to develop a complete REMS submission.
 
Participants will engage with former FDA staff to model REMS submission, review, negotiation, and approval of their program. Leading REMS experts will provide guidance throughout the process, including key operational considerations, risk management principles, and launch planning for the modeled program.
 
Come join us in Miami this September for the most complete REMS educational workshop!
 

Registration Details:

You must be signed into your account to get member pricing.

Registration Rates
Registration Type   Attended RIC 2026 Annual Meeting* Additional from Company already registered*
 
Member $2,000 $1,500 $1,000
Non-Member $3,000 $2,500 $2,000
 *Discount code needed - email Akuback@remsconsortium.org for code

All prices are in USD per registrant. 

CLICK HERE TO REGISTER

Event Location: 

Buchanan Law Office
2 South Biscayne Blvd
Suite 1500
Miami, FL 33131-1822

 

Event Program:

Tuesday, September 1, 2026 - 8:00 AM - 5:00 PM 

  • Introductions and team assignments
  • Review of a hypothetical product
  • Strategic planning and timelines
  • Application of statutory factors: Anticipating FDA's perspective
  • REMS Logic Model application: Designing for Success
  • US and global considerations
  • Assessment plan development
  • Submission planning and REMS material development
  • Day 1 wrap-up

Wednesday, September 2, 2026 - 8:00 AM - 5:00 PM 

  • Launch and implementation planning
  • Modeled submission and FDA review
  • Regulatory negotiations
  • REMS decision
  • Approval and everything else
  • Assessments, maintenance and modifications
  • REMS release 

Thursday, September 3, 2026  - 8:00 AM - 2:00 PM 

  • Team presentations