• Address challenges of working with the added time constraints needed for an ETASU
• Budget the additional ETASU costs to ensure manufacturers develop and operate
  these systems safely
• Make sure the ETASU does not excessively burden patient access

• Understand pharmacy claims processing
• Discuss opportunities to incorporate REMs programs into pharmacy workflow
• Improve patient safety within REMs program

REMS programs are difficult enough in themselves – but implementing a shared system has another level of challenges teams must overcome.  

• Delegate responsibilities and duties 
• Hear how to apply, maintain and tackle issues that come with sharing a REMS database and infrastructure
• Ensure proper timing of submissions
• Coordinate editing efforts with your single REMS doc and materials 

REMS programs are complex endeavors, requiring input and participation from diverse teams within your company, external participants in the program, and often vendors. This session focuses on building streamlined and efficient methods for engagement among both cross-functional teams and external participants.

• Build an effective internal coalition to build and manage REMS
• Discuss best practices for engaging external stakeholders (i.e., patients, prescribers, pharmacies, and distributors)
• Allocate stakeholder responsibility for requirements
• Craft meaningful and effective communications to address risk

Engaging patients can influence research to be more patient centered, useful, and trustworthy and ultimately lead to greater use and uptake of research results by the patient and broader healthcare community

• Tackle new standards of Real-Time Prescription Benefit
• Hear the National Council for Prescription Drug Programs speak to the information needed to prescribers of REMS drugs
• Address the Electronic Prior Authorization work side-by-side with REMS as many insurers/payers now require this

Engaging patients can influence research to be more patient centered, useful, and trustworthy and ultimately lead to greater use and uptake of research results by the patient and broader healthcare community

• Optimize and conduct patient benefit–risk assessment 
• Achieve rapid market penetration and product uptake
• Review best practices for creating simple and detailed materials for REMS patients to easily read, understand and apply

Each product has a unique benefit/risk profile, and therefore will have individual risk management needs. How does Risk Management fit in at critical points in a development program, and ultimately influence determination of a final risk management approach prior to regulatory authority submission?

• Discuss methodical approaches to risk management evaluation
• Understand key timepoints in product development where risk management input and analysis is necessary
• Explore best practices for development of a holistic risk management approach, including necessary contingencies
• Discuss regulatory submission strategies and requirements

Patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. As experts in living with a specific condition, the patient and their perspective are critical to REMS success.

• Collect and utilize patient-focused approaches in drug development and regulatory decision-making
• Understand how to capture the patient voice
• Create an effective checklist with the patient in mind
• Outline risk assessment and treatment benefits with the patient first mentality 
• Communicate information that supports their decision-making