
July 15-16, 2025
American University College
Washington, DC
Innovating Risk Management Strategies by Empowering Cross-functional Collaboration and Using the Technology Available to Accomplish a Patient-Centric & FDA-Compliant REMS Program
Previous Attendees






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Target Audience
This summit is tailored for professionals involved in the design, implementation, and oversight of Risk Evaluation and Mitigation Strategies (REMS), including experts from Regulatory Affairs, Pharmacovigilance, Drug Safety, Medical Affairs, and Compliance. Ideal for those navigating FDA requirements, enhancing REMS program effectiveness, and ensuring patient safety while supporting product access.
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Networking
Connect with regulatory, safety, medical affairs, and compliance professionals involved in REMS through interactive discussions, live Q&A, and virtual networking sessions. Share experiences, explore collaborative solutions, and build relationships with peers and thought leaders shaping the future of risk evaluation and mitigation strategies.
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Program Design
Each Momentum event is thoughtfully crafted to address the evolving landscape of drug safety, with a focus on Risk Evaluation and Mitigation Strategies (REMS). Our program features in-depth sessions and case studies that explore how REMS programs are shaping safer drug use practices across healthcare.
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Featured Speakers
Meet the Minds Behind Our Awesome Event

Josue Bautista Arteaga
GCP/PV Auditor
NOVARTIS

Brendan Collins
Director, REMS Customer Engagement
BRISTOL MYERS SQUIBB

Kal Elhoregy
Senior Director, Global Risk Management & Pharmacovigilance Compliance
AMNEAL PHARMACEUTICALS

Samuel Ewusie
Global Associate Director, Grm TA, Risk Management
BRISTOL MYERS SQUIBB

Kevin Holman
Sr. Director, REMS and US Pharmacovigilance
JOHNSON & JOHNSON

Catina O’Leary
President & CEO
HEALTH LITERACY MEDIA

Maha Saad
Vice President, Pharmacovigilance and Product Safety
LARIMAR THERAPEUTICS

Chirag Sheth
Sr. Director, REMS and Risk Management
ASTRAZENECA

Nikki Walters
Associate Director, REMS Technology
SYNEOS HEALTH

Louisa Miars
Associate Director, Risk Management Programs
THERMO FISHER/PPD

Tracy Gentile
Project Director, REMS Operations
UBC

Louela Taylor
Implementation lead
J&J
No results
Interested in Becoming Part of the Speaking Faculty?
Program Agenda: Day One
July 15, 2025
7:45 AM ET
REGISTRATION AND NETWORKING BREAKFAST
8:45 AM ET
CHAIRPERSON’S OPENING REMARKS
Kevin Holman
Sr. Director, REMS and US Pharmacovigilance
J&J
9:00 AM ET
REMS RELEASE - PLANNING and IMPLICATIONS
Discuss Positive Outcomes and Challenges Post REMS along it’s Planning and Execution
- Elaborate a Post-REMS monitoring plan to collect feedback
- Have an operational plan in place that involves all the stakeholders and update SOPs
- Handle the documentation and data and prepare the evidence package for FDA submission
Kevin Holman
Sr. Director, REMS and US Pharmacovigilance
J&J
9:45 AM ET
REMS STAKEHOLDER AUDIT PREPARATION AND READINESS
Explore how proactive preparation can transform the perception of a stakeholder audit from a disruptive event into an opportunity to:
- Build collaborate
- Ensure patient safety
- Instill confidence with your key stakeholders
Tracy Gentile
Project Director, REMS Operations
UBC
10:30 AM ET
NETWORKING BREAK
11:00 AM ET
INTERACTIVE SESSION: INSPECTION TRENDS & EVOLVING INSPECTOR APPROACHES
Bridge the Gap Between Audits and Inspections
- Explore how the new generation of inspectors is changing the landscape
- Review key challenges companies are facing with these new approaches
- Let’s engage in a Mock Inspection drill exercise led by our faculty members
Kal Elhoregy
Senior Director, Global Risk Management & Pharmacovigilance Compliance
AMNEAL PHARMACEUTICALS
Josue Bautista Arteaga
GCP/PV Auditor
NOVARTIS
Louisa Miars
Associate Director, Risk Management Programs
THERMO FISHER/PPD
12:30 PM ET
LUNCH BREAK
1:30 PM ET
TRANSFORMATIONAL REMS TECHNOLOGY
Discuss How Syneos Health REMS Technology Approach Reduces Operating Costs, Simplifies Sponsor Oversight, and Minimizes Stakeholder Burden
Nikki Walters
Associate Director, REMS Technology
SYNEOS HEALTH
2:15 PM ET
REMS CUSTOMER ENGAGEMENT ON SELF-SERVICE AND ASSISTED CHANNELS
Reduce Patient Burden with Efficiency and Innovation
- Showcase call center upgrades and innovations
- Help customers navigate REMS requirements
- Utilize different capabilities for better support customers
Brendan Collins
Director, REMS Customer Engagement
BMS
3:00 PM ET
NETWORKING BREAK
3:30 PM ET
INTERACTIVE SESSION: BUILDING A REMS
Hands-on Workshop where Participants will Collaborate to Design REMS Programs
- Led by our REMS experts who will create the base framework for the activity
- Work in teams to enhance and improve networking and idea sharing with different industry stakeholders
Maha Saad
Vice President Pharmacovigilance and Product Safety
LARIMAR THERAPEUTICS
4:15 PM ET
REMS CodeX INTEGRATION USE CASE PROGRAM UPDATE
Overview of the REMS CODEX Program Latest Updates
- How the program is reshaping REMS processes for better patient safety
- New insights and developments in the program
- Discuss next steps and what should be expected from the program
5:00 PM ET
COCKTAIL RECEPTION
Program Agenda: Day Two
July 16, 2025
8:00 AM ET
NETWORKING BREAKFAST
8:50 AM ET
CHAIRPERSON’S OPENING REMARKS
Kevin Holman
Sr. Director, REMS and US Pharmacovigilance
J&J
9:00 AM ET
INTERACTIVE SESSION: REIMAGINE REMS IN A CHANGING LANDSCAPE
Think Beyond Traditional Constraints and Envision Practical Improvements to Enhance Patient Safety and REMS/PV Program Efficiency.
- Identify actionable opportunities for enhancing REMS programs while maintaining regulatory compliance
- Share common challenges and workshop potential solutions in a non-competitive, patient-focused environment
- Explore innovative approaches to program efficiency in the context of industry changes
Catina O'Leary
President & CEO
HEALTH LITERACY MEDIA
10:30 AM ET
NETWORKING BREAK
11:45 AM ET
GOVERNMENT, POLICIES AND REGULATIONS
Discuss the Latest Regulatory Shifts and the Impact on the Industry
- Understand the impacts of new policies on Risk Evaluation and Mitigation Strategies
- What to expect from the FDA moving forward
- Review the recent FDA guidelines on AI
12:30 PM ET
LUNCH BREAK
1:00 PM ET
PANEL DISCUSSION: PATIENT REMSTRICITY & PATIENT WELLNESS
Understand Current Trends and the Importance of Keeping Patients at the Center of Risk
Strategies
- Integrating patient feedback and outcomes into risk mitigation efforts
- Explore how to simplify the patient journey with tools to reduce the burden
- Find the balance between Compliance and Compassion
Samuel Ewusie
Global Associate Director, Grm TA, Risk Management
BRISTOL-MYERS SQUIBB
1:45 PM ET
PANEL DISCUSSION: THE FUTURE OF REMS
Discuss How REMS Programs are Evolving and What the Future Holds
- Analyze the benefits of cloud services that integrate every stakeholder to have access to the information, from manufacturers to pharmacies
- Collaborate with international regulatory agencies, industry partners, and healthcare organizations to harmonize REMS requirements, and facilitate global alignment
- Discover new technology offerings in the REMS space that will help optimize and reduce burdens
Chirag Sheth
Sr. Director, REMS and Risk Management
ASTRAZENECA
Pricing
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Venue
AMERICAN UNIVERSITY WASHINGTON COLLEGE OF LAW
4300 Nebraska Ave NW,
Washington, DC 20016,
United States

Attendees and Speakers have been booking Sleeping Rooms at our Recommended Hotel, the Hilton Garden Inn Bethesda Downtown. Please book your room directly by clicking on the link below
Testimonials
"Presentations were extremely engaging"
"Event was very well organized and the Sponsors were great"
"Great event, with a “relaxed” feel that fosters collaboration"
Interested in learning more?
Frequently Asked Questions
-
1. Why Should I Attend? (aka: What's In It for Me?)
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
-
2. Who Should Attend? (Hint: It Might Be You)
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
-
3. Can I Register a Group? (Squad Goals: Activated)
Yes! Bring your crew. Whether it’s your department, your leadership team, or your whole company — group registration is easy and comes with perks. Discounts? You bet. Better collaboration back at the office? Definitely. Reach out to us for custom group packages and let’s make it a team experience.
Interested in Group Rates?
Email Solange Leclair at Solange@momentumevents.com to secure the best group discounts
-
4. What’s the Event About? (The Elevator Pitch)
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.!
-
6. Interested in Sponsorship? (Let’s Talk Visibility + Value)
Want your brand in front of the right people, in the right way, at the right time? Our sponsorship opportunities are customizable, creative, and designed to deliver ROI. From thought leadership to branding to curated meetings — let’s create something impactful. Drop us a line and we’ll cook up something special.
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.
Interested in learning more?
Click below to schedule a meeting with our sponsorship team!
-
7. How Do I Network? (Spoiler: It’s Easier Than You Think)
We make networking feel natural — not awkward. From structured roundtables and topic lounges to networking receptions and interactive sessions, there are plenty of ways to meet people who matter to your work (and might just become collaborators or friends). Just bring your curiosity — we’ll handle the rest.

Frequently Asked Questions
-
What are the top reasons why I should attend?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
-
Can I register a group?
We offer group discounts for teams attending the conference, providing a valuable chance to connect with remote colleagues.
Interested in Group Rates?
Email Solange Leclair at Solange@momentumevents.com to secure the best group discounts
-
What is the Event About?
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.!
-
VenueAMERICAN UNIVERSITY WASHINGTON COLLEGE OF LAW 4300 Nebraska Ave NW,
Washington, DC 20016,
United StatesOptional Venues Close to Campus
If you are looking to book a room to attend the conference please review the Link below
-
Sponsorship2025 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.
Interested in learning more about Sponsorship Opportunities?Contact Lauren Arcady at Laurenb@momentumevents.com to get a customized quote today!
