Forward Planning Analysis, Innovation, Patient Centricity and FDA Compliance as a Strategic Framework To Execute Successful REMS Programs

August 2-3, 2022 | Alexandria, VA

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.  15 years have passed since REMS was first implemented. We will deep dive into what has happened in this time, how REMS has evolved, the progress we are seeing to inform how the industry can optimize REMS moving forward in all stages.

This event will focus on how to work with sponsors and attract new ones, analyzing the FDA new ideas in terms of patient wellness and participation. We will focus on adjustments needed to stay up to date with technology, artificial intelligence and new platforms, the focus on patient education and prioritization for REMS and RMPs

MEET OUR SPEAKERS

Anupam Agarwal
Anupam Agarwal
Vice President, Global Head of Drug Safety and Pharmacovigilance

ZOGENIX

Nancy Dubois
Nancy Dubois
Head of Global Patient Safety/US Region

EMD SERONO

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

AMNEAL PHARMACEUTICALS

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

AIMMUNE THERAPEUTICS

Kishore Gopu
Kishore Gopu
Senior Director, REMS Operations

TEVA PHARMACEUTICALS

Suzanne Marinello
Suzanne Marinello
Risk Management Lead

JOHNSON & JOHNSON

Jaylaxmi Nalawade
Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS

LUPIN PHARMACEUTICALS

Catina O’Leary
Catina O’Leary
President and CEO

HEALTH LITERACY MEDIA

Michele Riggen
Michele Riggen
Associate Director, KAB Programs

UBC

Eleni Samaras
Eleni Samaras
Risk Evaluation & Mitigation Strategy Lead

GSK

Carmit Strauss
Carmit Strauss
Director, Global Safety (Benefit Risk Management Officer)

AMGEN

Bill Trombetta
Bill Trombetta
Professor of Healthcare Strategy & Marketing

SAINT JOSEPH’S UNIVERSITY

Sheline Way
Sheline Way
Associate Director, REMS Operations

TEVA PHARMACEUTICALS

Top Reasons to Attend

  • Evaluate the use of AI in REMS for the greater good of every stakeholder, from patients to the FDA involvement
  • Optimize patient education, wellness and health literacy, the key elements to great and successful REMS programs
  • Develop best practices on how to efficiently document Safety and Adverse Events on REMS while remaining FDA compliant
  • Understand the impact and growth from telemedicine and how to accommodate in the REMS space
  • Analyze assessment metrics and determine the processes of approval for REMS programs
  • Review the evolution of REMS, success, pitfalls, room for improvement and the continued growth of the programs

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
  • Patient Centricity – Patient Wellness

Thank you to our Sponsor

If you’re interested in Sponsorship Opportunities, please contact Meg Larson at meg@momentumevents.com

Pricing

PHARMACEUTICAL / MEDICAL DEVICES / BIOTECHNOLOGY

SOLUTIONS PROVIDERS / VENDORS

Groups discounts are available, if you wish to know more about them, please contact Frank Fernandez at frank@momentumevents.com

Click here to view the cancellation/refund/transfer policy