REMS managers face constant but predictable challenges, and must always be prepared to hurdle them. This session works through an overview and effective strategies for different REMS Elements to Assure Safe Use (ETASU).
- Evaluate the essentials of a REMS program
- Set manageable goals to hit timeline markers and budgets
- Tackle the continuous issues head-on=
A shared system can significantly reduce the burden for stakeholders across the REMS. Developing a shared REMS requires first clarifying internal and external strategies.
- Assess the development process for a shared system REMS
- Leverage the NCPDP standards in REMS
- Review current procedures and methods
- Discuss next steps towards implementation and adoption
Sudden and unpredictable challenges can occur at any turn. You will be best-suited for your own REMS program by learning from others who confronted the toughest issues and overcame them.
- Navigate issues that can go awry at any time during the REMS life cycle
- Discuss case studies from those in the thick of the REMS system
- Hear issues that you can come across that aren’t in the guidelines
FDA may require ETASU for a product associated with serious risks. What are the most effective and reliable way for you to navigate these additional steps?
- 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
Despite ongoing standardization, many REMS continue to utilize unique or non-standard elements or processes. Explore past experience and case studies when it comes to negotiating with the FDA.
- Discuss common challenges during the NDA
- Tackle issues faced from various NDAs
- Address key areas for alignment during REMS negotiations with FDA
There are multiple new Task Group initiatives under way with specialty pharmacy and payers. Keeping track of these new developments can help set up your REMS for success.
- 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
Organizing and preparing throughout REMS development can help you ensure the satisfactory documentation required. You and your teams will have to develop CAPAs that implement best practice and address any areas of noncompliance.
- Ensure your Audit Plan is comprehensive and actionable
- Explore challenges and solutions related to program noncompliance
- Build effective communication techniques with the FDA about noncompliance and CAPAs
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
Your strategy needs to include effective training for pharmacies and addressing product risk through them. This session addresses REMS standardization from a pharmacy point of view.
- Highlight effective training and pharmacy compliance management
- Initiate appropriate data and pharmacy requirements
- Efficiently keep up with policies and procedures
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
Mergers and acquisitions commonly occur in the pharmaceutical industry. Through proper planning for the uncertainty around these changes, you can make sure your REMS programs are not adversely impacted.
- Review a recent merger case study, featuring pitfalls and lessons learned
- Adapt and assimilate to your next merger
- Navigate the new and old internal partner roles
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
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
Technologies upcoming in 2021 and beyond can help ensure your REMS is effectively implemented and assessed. These new approaches and others will drive REMS programs into the future.
- Explore new technology and tools that can increase efficiency of drug distribution
- Apply techniques that will ensure safety
- Guarantee patients have all the information for medication distribution and use
