Event Schedule

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

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

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

Apply a logic model to the design and evaluation of REMS programs can enable a systematic approach to linking REMS objectives and interventions to the outputs and outcomes.

  • Link REMS input (design) and outputs (evaluation)
  • Complete a situational analysis taking into consideration the system, prescriber and patient level characteristics and preferences.
  • Ensure input from healthcare providers and patients during the risk management life-cycle
  • Determine and set primary and secondary endpoints for your REMS programs

PANEL: Prepare for REMS Audits

Explore the value of incorporating novel technologies to REMS operations, delivering a more connected healthcare ecosystem.

  • Implement biometrics and QR code with ease
  • Understand the importance of Optical Character Recognition (OCR)
  • Discuss in-workflow direct connections in depth

FDA REMS guidelines and EMA GVP module XVI guidelines provide guidance in regards to REMS programs and EU additional risk minimization measures development update and evaluation

  • Explore shared requirements among regulators and guidance’s
  • Develop REMS program and REMS strategy with key global considerations in mind

Prepare for the approval and launch of an internally resourced ETASU REMS requires strategic planning, thoughtful REMS program operational development, and much collaboration. How is this approach affected when a REMS Sponsor could potentially have 2 products in the same class with the same identified risks launching in the same year?

  • Challenges and opportunities for REMS Program strategy
  • Utilize REMS operational efficiencies
  • Apply the learnings and innovation to REMS technology solutions to support a global multiproduct risk management platform

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

Pharmacies are well positioned to ensure patient compliance with REMs programs. Pharmacy workflow is unique as they process claims in real-time using NCPDP standards. It is essential that REMs programs be incorporated into pharmacy workflow to mitigate burden and ensure compliance.

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

Managing REMS Internal and External Stakeholders

REMS programs are difficult enough in themselves – but implementing a shared system has another level of challenges teams must overcome. Laura Zendel, Team Leader, FDA

  • 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

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

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 Deborah Collyar, Founder and President, PAIR: Patient Advocates In Research

  • 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. Suzanne Marinello, Associate Director, REMS and Patient Support, OTSUKA PHARMACEUTICALS

  • 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

Do you know what is happening with your REMS department growth? Two academically partnered Risk Management Fellowship Program leaders and former FDA REMS directors will have a fireside chat discussing:
  • Current experiences with Risk Management Fellowship Program development, recruitment and operations
  • Structured risk management education
  • Analyze your current structure to evaluate readiness for a potential Fellowship or training program
  • Experience of current Fellows
The specialty pharmacy provider must demonstrate the flexibility to support REMS requirements that come in all shapes and sizes. The more a specialty pharmacy can understand the needs of a specific manufacturer program, the greater its opportunities will be for inclusion in a distribution model that requires a REMS.
  • Demonstrate a commitment to the success of the program and the product
  • Understand the manufacturer’s perspective and potential risk associated with non-compliance
  • Exhibit the ability to interact with stakeholders across a variety of touch points
  • Meet PMRs using REMS data
  • Explore additional data to supplement REMS for Sponsor insights
  • Discuss comparisons with European risk management
Half of REMS assessments do not include all of the information requested in FDA assessment plans. Deeper awareness of these regulatory expectations can help you ensure accuracy of your evidence based assessments.
  • Develop alternative methods for more accurate assessments
  • Implement standardized formats for reports
  • Employ resources to meet required timeframes
Should you use a third-party vendor to write or manage your REMS? New technologies can make your processes far more efficient, but these are not “plug-and-play”: you will need strong and reliable relationships with all your service providers.
  • Ensure all stakeholders have up to date information for proper drug distribution
  • Pinpoint techniques that minimize the risk
  • Explore new tools for drug distribution
Implementing and reporting patient and prescriber KAB surveys are essential to evaluation of REMS effectiveness. While you can build on lessons learned, no survey approach is exactly the same and new challenges constantly arise that affect survey implementation. Such challenges can derive from the REMS Program or from the survey process itself. You will be best-prepared for your own REMS KAB survey program by learning from others who have confronted the toughest challenges and overcome them.
  • Implement KAB surveys with ease
  • Hear issues that you can come across in KAB survey development and implementation
  • Learn key lessons from responses that succeeded in overcoming these challenges
  • Build adaptable systems capable of rapid response
McKesson’s recent departure from the REMS space has brought with it novel challenges for pharmacies. NCPDP has suggested initiatives to counteract these, but your teams will need to learn and adapt quickly as the marketplace changes. This session describes new processes and approaches that are less burdensome for pharmacists who have to interface with REMS.
  • Discuss opportunities to incorporate REMs programs into pharmacy workflow
  • Specify and adapt to the changes caused by departure of the “switch” pharmacy management system
  • Work with your retail pharmacist with ease
Are your programs able to meet the goals as defined in the REMS? Or were the goals put into place unrealistic?
  • Handle FDA requests quickly and with accuracy
  • In depth look at REMS modifications
  • Manage the unpredictability of contractors
Communication about the risks of medicines is not a new concept, but the tactics and technology are ever-changing. Risk professionals need to prep for constant interactions with patients, HCPs, policymakers, and the general public in order to manage risks with medicines appropriately and reduce patient harm.
  • Increase transparency and improve awareness in your communication
  • Explore how to put established principles into practice and to experiment with new approaches
  • Consistently distribute informational materials through professional societies for communication transparency
This case study will review the key components of the Soliris REMS and describe methods by which the marketing authorization holder has revised components of the REMS to increase compliance.
  • Explore the challenges experienced with implementation of the REMS program in the current US healthcare system
  • Hear potential future improvements to increase REMS compliance
  • Avoid red flags and penalties with effective organization techniques
It is the responsibility of your entire team to make sure REMS are properly implemented and that all information in assessment reports is accurate. Do you have the necessary training and oversight systems in place?
  • Ensure compliance is followed within REMS requirements
  • Prepare for REMS inspections which are highly regulated as well as those which are non regulated
  • Learn from past instances of mistakes and failure