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REMS Logo White

 

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.

Featured Speakers

Meet the Minds Behind Our Awesome Event

Filter Speakers:
Josue-Bautista-Arteaga
Josue Bautista Arteaga

GCP/PV Auditor

NOVARTIS

Brendan-Collins
Brendan Collins

Director, REMS Customer Engagement

BRISTOL MYERS SQUIBB

Kal-Elhoregy
Kal Elhoregy

Senior Director, Global Risk Management & Pharmacovigilance Compliance

AMNEAL PHARMACEUTICALS

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Samuel Ewusie

Global Associate Director, Grm TA, Risk Management

BRISTOL MYERS SQUIBB

Kevin-Holman
Kevin Holman

Sr. Director, REMS and US Pharmacovigilance

JOHNSON & JOHNSON

Catina OLeary
Catina O’Leary

President & CEO

HEALTH LITERACY MEDIA

Maha Saad
Maha Saad

Vice President, Pharmacovigilance and Product Safety

LARIMAR THERAPEUTICS

Chirag Sheth
Chirag Sheth

Sr. Director, REMS and Risk Management

ASTRAZENECA

Nikki-Walters
Nikki Walters

Associate Director, REMS Technology

SYNEOS HEALTH

Louisa Miars
Louisa Miars

Associate Director, Risk Management Programs

THERMO FISHER/PPD

Tracy Gentile
Tracy Gentile

Project Director, REMS Operations

UBC

Louela Taylor
Louela Taylor

Implementation lead

J&J

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

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

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

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

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

 

Josue-Bautista-Arteaga

Josue Bautista Arteaga
GCP/PV Auditor 
NOVARTIS 

 

Louisa Miars

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

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

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

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

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 OLeary

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

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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

Chirag Sheth
Sr. Director, REMS and Risk Management 
ASTRAZENECA 

Pricing

 

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Pharmaceutical / Medical Device / Biotech Companies

Standard Rate

Register after 06/20/2025

$2295

Early Bird!

Register by 05/23/2025

$1895

$400 savings

Advanced Rate

Register by 06/20/2025

$2095

$200 off

Standard Rate

Register after 06/20/2025

$2295

 

Advanced Rate

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$2095

$200 off

Standard Rate

Register after 06/20/2025

$2295

 

Solution Providers / Vendor Companies

Standard Rate

Register after 06/20/2025

$3495

Early Bird!

Register by 05/23/2025

$3095

$400 savings

Advanced Rate

Register by 06/20/2025

$3295

$200 off

Standard Rate

Register after 06/20/2025

$3495

 

Advanced Rate

Register by 06/20/2025

$3295

$200 off

Standard Rate

Register after 06/20/2025

$3495

 

Click here to view the cancellation/refund/transfer policy 

Venue

 

AMERICAN UNIVERSITY WASHINGTON COLLEGE OF LAW

4300 Nebraska Ave NW,
Washington, DC 20016,
United States

AMERICAN-UNIVERSITY-COLLEGE

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

 

2025 Sponsors

 

GOLD SPONSORS

SILVER SPONSOR

Testimonials

 

"Presentations were extremely engaging"
Sr. Director, REMS
UBC 
"Event was very well organized and the Sponsors were great"
Director REMS Operations
Janssen 
"Great event, with a “relaxed” feel that fosters collaboration"
Director, Risk Management Strategy
Janssen Pharma 

Interested in learning more?

Click below to schedule a meeting with our sponsorship team!
 

Frequently Asked Questions

 

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Frequently Asked Questions

 

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