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

Anupam Agarwal
Anupam Agarwal
Global Executive Director, Drug Safety

ZOGENIX

Eleni Allen
Eleni Allen
Director, REMS Strategy and Execution

GSK

Deborah Collyar
Deborah Collyar
President

PATIENT ADVOCATES IN RESEARCH

Michele Davidson
Michele Davidson
Sr. Mgr, Pharmacy Technical Standards, Development and Policy

WALGREENS

Nancy Dubois
Nancy Dubois
Senior Manager, Risk Evaluation and Mitigation Strategies

ALEXION

Kal Elhoregy
Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs

AMNEAL PHARMACEUTICALS

Bertha Ferrer
Bertha Ferrer
Senior Director, Head of Quality Management and Inspections

PFIZER

Jacqueline Gerena
Jacqueline Gerena
Director, Program Management (REMS Program)

AIMMUNE THERAPEUTICS

Kishore Gopu
Kishore Gopu
Senior Director, REMS Operations - TEVA PHARMACEUTICALS
Kyle Irwin
Kyle Irwin
Operations Lead – REMS and Risk Management

JOHNSON & JOHNSON

Carlene MacMillan
Carlene MacMillan
Medical Director, Product and Growth

OSMIND

Madalo Maliro
Madalo Maliro
Senior Manager, REMS Program

AIMMUNE THERAPEUTICS

Suzanne Marinello
Suzanne Marinello
Associate Director REMS and Patient Support

OTSUKA

Sherice Mills
Sherice Mills
Senior Director – Benefit Risk Management

JAZZ PHARMACEUTICALS

Owen Muir
Owen Muir
CEO

BROOKLYN MINDS

Jaylaxmi Nalawade
Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS

LUPIN PHARMACEUTICALS

Catina O’Leary
Catina O’Leary
President & CEO

HEALTH LITERACY MEDIA

Chantal Phillips
Chantal Phillips
Former Risk Evaluation and Mitigation Strategies (REMS) Coordinator Team Lead

FORMER FDA

Jimmy Qian
Jimmy Qian
Co-Founder and COO

OSMIND

Jennifer Reinert
Jennifer Reinert
Director, Risk Management Product Lead, Worldwide Safety and Regulatory

PFIZER

Sheline Way
Sheline Way
Senior Manager, REMS Operations

TEVA PHARMACEUTICALS

Jamie Wilkins
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