Risk Evaluation and Mitigation Strategy (REMS) Innovation Summit

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

August 2-3, 2022- Alexandria, VA, United States

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

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

Speaker Faculty

  • Anupam Agarwal, Vice President, Global Head of Drug Safety and Pharmacovigilance, ZOGENIX
  • Eleni Samaras Allen, Director, REMS Strategy and Execution, GSK
  • Nancy Dubois, Head of Global Patient Safety/US Region, EMD SERONO
  • Kal Elhoregy, Director, Risk Evaluation and Mitigation Strategy (REMS) Programs, AMNEAL PHARMACEUTICALS
  • Kishore Gopu, Senior Director, REMS Operations, TEVA PHARMACEUTICALS
  • Suzanne Marinello, Risk Management Lead, JOHNSON & JOHNSON
  • Jaylaxmi Nalawade, Associate Director – Pharmacovigilance and REMS, LUPIN PHARMACEUTICALS
  • Catina O’Leary, President and CEO, HEALTH LITERACY MEDIA
  • Matt Page, Team Lead, Center for Post Approval Safety Studies, TAKEDA
  • Michele Riggen, Associate Director, KAB Programs, UBC
  • Carmit Strauss, Director, Global Safety (Benefit Risk Management Officer), AMGEN
  • Bill Trombetta, Professor of Healthcare Strategy & Marketing, SAINT JOSEPH’S UNIVERSITY
  • Sheline Way, Associate Director, REMS Operations, TEVA PHARMACEUTICALS

Please fill in your name and email to receive the Summit Agenda of this event.

Venue

Hilton Alexandria Old Town
1767 King Street, 22314
Alexandria, VA, USA

A limited and exclusive room block is available for the 2nd REMS Innovation Summit. To take advantage of our discounted room rate of $169++ please use this link or call the venue 703 837 0440 and reference the event name. The group rate is available until July 18, 2022.

Please note there is only one official, exclusive housing block for this event. Any other channels for booking reservations are not authorized. If you are contacted by a 3rd party housing company claiming to have a relationship with Momentum Events Group LLC, its event and/or The Hilton Alexandria Old Town; these companies and others like it are not in any way affiliated with us.