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

August 2-3, 2022 | Alexandria, VA

AGENDA – ALL TIMES ARE IN EASTERN TIME

  • 15 years into REMS Programs, progress and upgrades
  • Understanding the challenges that new work and investment to better serve every stakeholder involved in REMS programs
  • Factors that have helped and harmed REMS development
  • Technology and how to maximize its use as a benefit for REMS programs
Anupam Agarwal
Vice President, Global Head of Drug Safety and Pharmacovigilance
ZOGENIX
  • How to integrate and keep every sponsor up to date on Shared System REMS, communication and information sharing are key
  • Dealing with Inspections from FDA when there multiple stakeholders involved
  • Technology aid the will help Shared System REMS be more efficient and allow a better flow of information
Sheline Way
Associate Director, REMS Operations
TEVA PHARMACEUTICALS
  • Understand the scope of every stakeholder involved in REMS
  • Learn how by working together we can improve the REMS Program for everyone involved
  • Increase the success rate of your REMS Programs by taking every stakeholder into consideration
  • The importance of feedback and communication and to focus on reducing the burden for all the stakeholders involved
Anupam Agarwal
Vice President, Global Head of Drug Safety and Pharmacovigilance
ZOGENIX

Kishore Gopu
Senior Director, REMS Operations
TEVA PHARMACEUTICALS

Eleni Samaras Allen
Director, REMS Strategy and Execution
GSK
  • Designing and implementing KAB surveys
  • Handling FDA feedback
  • Conducting KAB surveys in the context of a Shared System REMS
  • Comparison of REMS KAB surveys with effectiveness of aRMM surveys in the EU
Matt Page
Team Lead, Center for Post Approval Safety Studies
TAKEDA
  • Requirement safety similarities and differences between REMS and RMPs
  • The need to work on a REMS program even if its not required, good to have on your backpocket as the RMP is in place
  • Working on a global scale, implementing and complementing REMS and RMPs to guarantee successful global safety features
Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
AMNEAL PHARMACEUTICALS

Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS
LUPIN PHARMACEUTICALS
  • The use of technology to better serve all REMS programs stakeholders
  • Patient involvement encouraged by the user friendly systems and REMS related tools
  • Integrating different aspects of REMS programs to have all the information in one place
Anupam Agarwal
Vice President, Global Head of Drug Safety and Pharmacovigilance
ZOGENIX
  • The importance of metrics in the approval process for your REMS program
  • Choose the type of metrics that will help your REMS program, they can change depending if the REMS is a single or a shared system REMS
Jaylaxmi Nalawade
Associate Director - Pharmacovigilance and REMS
LUPIN PHARMACEUTICALS
  • Thrive for excellence on your REMS programs, make every aspect and every person involved committed to the BEST REMS program possible
  • Analyze adding layers to your REMS program to guarantee the best possible outcomes for every stakeholder
  • Eye on the prize - deliver quality programs to fulfill the ultimate purpose, reducing risk and benefiting patients
  • Steps and procedures needed to be ready for the highly regulated audits and inspections
  • Involve all the stakeholders and keep them informed so everyone has the same approach and drive when facing an audit or an inspection
  • Keep information and feedback ready to be applied
Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
AMNEAL PHARMACEUTICALS
  • Make sure your patients understand the risks and the benefits of the REMS program
  • Share the information and provide platforms so your patients can share feedback that can make the experience improve
  • Invest in the most important aspect of the REMS - the well-being of your patients
Carmit Strauss
Executive Director, Head of Risk Management and Organ Toxicity
TAKEDA
  • Drive your REMS Program targeting the patient outcome as the priority
  • Facilitate to the patient all the tools and information they require and need to feel a central piece of the REMS Program
  • Focus the strength of the different stakeholders to focus on the patient centricity success
  • Make sure your patients understand the risks and the benefits of the REMS program
  • Share the information and provide platforms so your patients can share feedback that can make the experience improve
  • Invest in the most important aspect of the REMS - the well-being of your patients
Catina O’Leary
President and CEO
HEALTH LITERACY MEDIA
As of the Affordable Care Act 0f 2010, healthcare is moving from volume based care to value based care. The Triple Aim rules: 1) improve patient outcomes; 2) lower costs; 3) enhance access to and satisfaction with healthcare. The goal is to keep people healthy and out of expensive emergency rooms and hospital beds.

REMS can be a springboard for Value-Based Partners to enter into Value-Based Arrangements targeted to specific patient populations such as Medicare and Medicaid.

Bill Trombetta
Professor of Healthcare Strategy & Marketing
SAINT JOSEPH’S UNIVERSITY