Innovative Approaches, Technology, and
Partnerships to Ensure Your REMS Strategy is
Optimized, Patient-Centric, and FDA Compliant
On-Demand Content | Virtual Event
If you purchased this event and have any questions please email roberta@momentumevents.com
Innovating in the REMS space is critical, not only talking about technology but also talking about the approach with the FDA, the processes and the way we communicate with all the stakeholders internal and external. This event will explore some of the pressing issues for REMS like the use of technology that benefits all the stakeholders, how to educate and prepare the patient so they can feel truly a part of the program, the development, operationalization and compliance in REMS programs.
This REMS Innovation Summit focuses on REMS in a variety of ways such as patient wellness, perspectives from every stakeholder in the REMS space, inspection readiness, operational excellence, SSS REMS, patient safety procedures and more.
MESSAGE FROM OUR CO-CHAIRPERSONS
MEET OUR SPEAKERS
Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
AMNEAL PHARMACEUTICALS
Chantal Phillips
Former Risk Evaluation and Mitigation Strategies (REMS) Coordinator Team Lead
FORMER FDA
Anupam Agarwal
Global Executive Director, Drug Safety
ZOGENIX
Eleni Allen
Director, REMS Strategy and Execution
GSK
Deborah Collyar
President
PATIENT ADVOCATES IN RESEARCH
Michele Davidson
Sr. Mgr, Pharmacy Technical Standards, Development and Policy
WALGREENS
Nancy Dubois
Senior Manager, Risk Evaluation and Mitigation Strategies
ALEXION
Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
AMNEAL PHARMACEUTICALS
Bertha Ferrer
Senior Director, Head of Quality Management and Inspections
PFIZER
Jacqueline Gerena
Director, Program Management (REMS Program)
AIMMUNE THERAPEUTICS
Kishore Gopu
Senior Director, REMS Operations - TEVA PHARMACEUTICALS
Kyle Irwin
Operations Lead – REMS and Risk Management
JOHNSON & JOHNSON
Carlene MacMillan
Medical Director, Product and Growth
OSMIND
Madalo Maliro
Senior Manager, REMS Program
AIMMUNE THERAPEUTICS
Suzanne Marinello
Associate Director REMS and Patient Support
OTSUKA
Sherice Mills
Senior Director – Benefit Risk Management
JAZZ PHARMACEUTICALS
Owen Muir
CEO
BROOKLYN MINDS
Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS
LUPIN PHARMACEUTICALS
Catina O’Leary
President & CEO
HEALTH LITERACY MEDIA
Chantal Phillips
Former Risk Evaluation and Mitigation Strategies (REMS) Coordinator Team Lead
FORMER FDA
Jimmy Qian
Co-Founder and COO
OSMIND
Jennifer Reinert
Director, Risk Management Product Lead, Worldwide Safety and Regulatory
PFIZER
Sheline Way
Senior Manager, REMS Operations
TEVA PHARMACEUTICALS
Jamie Wilkins
Head- Risk Management Center of Excellence- Worldwide Safety
PFIZER
Top Reasons to Purchase
- Explore the different options on solution providers for REMS – How to increase the vendor pool and how to choose the right partner for your program
- Focus on how to improve patient outcomes and provide the patients the tools and education needed to fully and successfully participate in the REMS program
- Analyze and understand the different perspectives on a REMS program to gain empathy and a better understanding of all the stakeholders involved
- Understand the impact and growth from telemedicine and how to accommodate in the REMS space
- Master the guidances on when and how to plan specifics for your REMS strategy in a post/during -Covid world
- Transition from Individual RLD REMS to a Single Shared REMS Program including all Factors to consider in Negotiations and Alternatives
Who Should Purchase
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
- Patient Centricity – Patient Wellness
- Epidemiology/Pharmacoepidemiology
- 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
- Patient Centricity – Patient Wellness
- Epidemiology/Pharmacoepidemiology
On-Demand Content
$195