MARCH 27-28, 2023 | PHILADELPHIA, PA
Innovative Approaches, Technology and Partnerships to make your REMS Strategy Updated, Patient Centric and FDA Compliant
The 3rd REMS Innovation Summit will continue to innovate on the Risk Management space in both content and experience for everyone in attendance. Bringing back the audience’s favorite interactive roundtable discussions to enjoy the most engaging and complete REMS Experience! We will focus on REMS assessment reports, inspection readiness, the regulatory landscape including the new Guidance on Structured Product Labeling, the newest tech, and AI breakthroughs while focusing on reducing patient burdens.
2022 REMS Experience
TESTIMONIALS
I found it to be enlightening and reaffirming
Associate Director
TEVA
TEVA
Great presentations, very interactive
Executive Director, Business Development
UBC
UBC
It was both educational and fun
Senior Principal
Two Labs
Two Labs
Great atmosphere, small forum – conducive to valuable discussion across attendance
Head REMS
Indivior
Indivior
MEET OUR SPEAKERS
Suzanne Marinello
Senior Director, Risk Management and Patient Support Strategy
CHINOOK THERAPEUTICS
Eleni Samaras Allen
Director, REMS Strategy and Execution, US Medical Affairs
GSK
Pooja Babbrah
Pharmacy and PBM Practice Lead
POCP
Bertha Ferrer
Senior Director, Head of Quality Management and Inspections
PFIZER
Jacqueline Gerena
Director, Risk Management Strategy
JANSSEN
Melissa Landers
Senior Principal, Sheperd Safety Services
TWO LABS
Suzanne Marinello
Senior Director, Risk Management and Patient Support Strategy
CHINOOK THERAPEUTICS
Catina O’Leary
President and CEO
HEALTH LITERACY MEDIA
Kelee Petzelt
REMS Use Case Coordinator for CodeX
POCP
Bill Trombetta
Professor of Healthcare Strategy & Marketing
ST JOSEPH’S UNIVERSITY
Jamie Wilkins
Head-Risk Management Center of Excellence-Worldwide Safety
PFIZER
Top Reasons to Attend
Implementing technology and AI in REMS for the greater good of every stakeholder, from patients to the FDA involvement
Focus on Patient education, wellness and burden removal, the key elements to great and successful REMS programs
Document Safety and Adverse Events Reporting on REMS while being FDA compliant
Understand the impact and growth from telehealth and telemedicine and how to accommodate in the REMS space compliantly
Analyze REMS Regulatory landscape, past – present and future
Reinforce SPL Formatted Submissions new guidelines
WHO SHOULD ATTEND
This event is designed for pharmaceutical, biotech, and medical device professionals with responsibilities in the following areas:
- REMS
- Benefit/Risk Management
- Drug/Product Safety
- Pharmacovigilance/Surveillance
- Medical Direction
- Quality Assurance
- Clinical Risk Management
- Life Cycle Management
- Regulatory Affairs/Legal/Compliance
- Clinical Affairs
- Clinical Data Management
- Clinical Operations
- Clinical Risk Management Compliance
- Epidemiology/Pharmacoepidemiology
Silver Sponsors
SPONSORSHIP OPPORTUNITIES
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.