The COVID-19 pandemic has created numerous challenges and opportunities across the healthcare landscape. Regulatory authorities have provided emerging guidance during the pandemic that has the potential to impact ongoing regulatory expectations.
Explore several operational strategies that have proved successful and warrant long-term consideration
- Detail the key challenges and impacts across the three vital pillars; people, process, and tech
- Understand how to be risk averse while enabling Natural Language IVR/ NLU AI
- Explore several operational strategies that have proved successful and warrant long-term consideration
This session will focus on recent approaches to integrate REMS requirements into the normal workflow of healthcare providers and health care systems.
- Describe the potential REMS implementation benefits derived from innovative use of health information technology
- Examine the future potential of REMS ETASU integration and implementation throughout the health care delivery system via the use of the health information technology
- George NeyarapallyPharmD, JD, MPH, RPh, Regulatory Science Research Policy Lead Regulatory Science & Applied Research Team OSECDER, FDA
- James CurtisDirector, Software Development EngineerUBC
- Edward D. MillikanPharmD, RPh, Senior Clinical Informatics Pharmacist Division Of Mitigation Assessment And Medication Error Surveillance (DMAMES) Office Of Medication Error Prevention And Risk Management (OMEPRM) Office Of Surveillance And Epidemiology (OSE)CDER, FDA
- Ernie AnastasiDirector, Technical OperationsEXAMOTO A UBC COMPANY
Prioritize consistent communication efficacy, and abuse potential of drugs safety teams to manage risks with medicines appropriately and reduce patient harm. One of the biggest concerns across safety is who does what when, and it is all very connected but there is a need to justify.
- Increase transparency and improve awareness in your communication
- Explore how to put established principles into practice and to experiment with new approaches while building your team
- Consistently distribute informational material for complete transparency
One of the biggest concerns in drug safety is knowing in advance which team member takes which step and needing to get this right every time. Explore established principles into practice and experiment with new approaches while building your team.
- Increase transparency and improve awareness in your communication for Safety, Risk Management, and Pharmacovigilance across the product’s lifecycle
- Bring great value to your cross functional approach with safety governance (SMT and SAC), preparing aggregate reports (DSUR/ PBRER), safety surveillance and core data sheet etc
Small companies face the same rigor as large pharma – and it does not help that requirements are not the same among those categories. To stay on top of pharmacovigilance regulations and inspections, you need to build a system where all aspects stay in compliance and no warning signals are ever missed or ignored.
- Thorough review of safety data
- Identify advances in risk management strategies
- Discuss the regulatory landscape of safety surveillance for drug products including generics and biologics
REMS and Global Risk Management/global functions must work together to ensure that a product risk profile and the risk management programs that support the product are consistent. Try to remain consistent, standardized, and keep burden down.
- Determine risk management strategy for a product and hear how to apply same strategy globally
- Implement risk management strategy globally to ensure a guaranteed risk management system, whilst minimizing burden
- Understand the regulatory requirements and similarities between US REMS and EU RMP (with aRMMs)
Be sure to have continuous exercise throughout the product life cycle to evaluate the favorable and unfavorable effects of the drug.
- Weigh the benefit and risks of different forums and initiatives
- Discuss the appropriate usage of metrics
- Consider involving patients to factor in their perspectives on the benefits and risks of the product
Ensure all stakeholders are properly trained at all times for audits, including remote audits. Prepare for PV and REMS inspections which are highly regulated as well as those which are non regulated.
- Prepare for PV and REMS inspections which are highly regulated
- Ensure all stakeholders are properly trained at all times for audits, including remote audits.
- Make certain compliance is follower within the requirements
CMS prioritizes value-based care, where partners accept a certain amount of risk to keep patients healthy. But as healthcare providers aim to offer patients services above purely selling therapeutics with other regulations. How can drug safety and REMS professionals monitor and avoid these risk areas?
- Understand how REMS can act as a springboard for value-based arrangements that target specific patient populations
- Grapple with the emergence of social determinants of healthcare as a complicating factor
- Learn from recent instances of regulatory risk
Review an architecture of Safety-Radar – a system for evaluating drug safety including toxicity awareness and warning systems.
- Support automated reasoning and serendipitous discovery of new ‘facts’ or interesting and testable hypotheses
- Strategies of how to integrate and provide high-value AI-ready data sources
- Develop (semi) autonomous reasoning agents
Review REMS operation preparations and how REMS IT Systems can be simultaneously launch ready. Hear how the BMS team presents the exact PDUFA date: CAMZYOS REMS Case Study.
Dewey Seto, Associate Director, US REMS Strategy & Submission Program Lead, BRISTOL MYERS SQUIBB
- Dive deep into a first-in-class product
- Discuss REMS program including FDA negotiation & approvals
The post-marketing assessment of medicines plays a key role for better defining drug safety profiles in real-world settings. Now if you plan properly, you should have new successes in filling the evidence gap from pre-marketing studies.
- Discuss what PMRs and PMCs are and how to approach it strategically
- Utilize the improved access to large scale distributed database networks
- Provides new ways and opportunities to monitor the post-marketing safety
- Generate real-world evidence to support decision-making