Join us at the 5th REMS Innovation Summit on July 15-16, 2025, in Washington, D.C., where we’ll explore the evolving role of Risk Evaluation and Mitigation Strategies (REMS) in drug safety.
REMS are specialized safety programs mandated by the FDA for specific medications with serious safety concerns, ensuring their benefits outweigh potential risks. Unlike standard medication labeling, REMS reinforce behaviors and conditions that support safe medication use, helping reduce the occurrence and severity of specific risks.
This year’s summit will feature in-depth sessions and case studies, focusing on how REMS programs are shaping safer drug use practices across healthcare.
Don’t miss this opportunity to connect with industry leaders and peers dedicated to advancing medication safety. Mark your calendars for July 15-16, 2025, and join us in Washington, D.C.!
2024 TESTIMONIALS
2025 Speaking
Faculty
Kevin Holman
Sr. Director, REMS and US Pharmacovigilance
JOHNSON & JOHNSON
Brendan Collins
Director, Grm Rems Customer Engagement
BRISTOL MYERS SQUIBB
Kal Elhoregy
Sr. Director, Global Risk Management & PV Compliance
AMNEAL PHARMACEUTICALS
Josue Bautista Arteaga
GCP/PV Auditor
NOVARTIS
Jackie Gerena
Strategy Director, Risk Management
JOHNSON & JOHNSON
Chirag Sheth
Sr. Director, REMS and Risk Management
ASTRAZENECA
Catina O’Leary
President & CEO
HEALTH LITERACY MEDIA
Maha Saad
Vice President, Pharmacovigilance and Product Safety
LARIMAR THERAPEUTICS
Samuel Ewusie
Director Asociado Global, Grm TA, Gestión de Riesgos
BRISTOL MYERS SQUIBB
Nikki Walters
Associate Director, REMS Technology
SYNEOS HEALTH
Interested in Becoming Part of the Speaking Faculty?
Thank you to our 2025 sponsors
Gold Sponsors
2025 Sponsorship Opportunities are Open
Sponsorship is a great way to enhance your brand’s visibility and help you connect with top-level decision-makers, innovators, and industry disruptors. There are a number of ways to maximize branding opportunities at the summit.
Top Reasons to Attend
Grow and foster the relationship between your REMS and your Drug Safety peers to help reduce burdens and secure a more effective oversight and REMS implementation
Discuss effective and compliant REMS and AI applications and explore all the options and possibilities
Explore what Core Additional Risk Management Activities (CAR-T REMS) are being used by your peers
Create and build educational materials for REMS
Learn best practices based on recent Inspection experiences, prepare mock inspections and how to handle the aftermath of inspections
Document Safety and Adverse Events Reporting on REMS while being FDA-compliant
Who should attend?
This event is designed for pharmaceutical, biotech, and medical device professionals with responsibilities in the following areas:
- Benefit/Risk Management
- Medical Direction
- Quality Assurance
- Real-World Evidence Generation
- Clinical Risk Management
- Life Cycle Management
- Regulatory Affairs/Legal/Compliance
- Clinical Research
- Clinical Risk Management Compliance
- Epidemiology/ Pharmacoepidemiology