During this two-day Summit, attendees will examine an end-to-end REMS solution to help them comply with FDA safety requirements while ensuring patients have appropriate access to drugs and biologics. Industry professionals will convene to further the understanding of when REMS are required, the elements that need to be included in the REMS necessary for their product, as well as details needed for submission.
Top Reasons to Attend:
– Collaborate with industry leaders on innovative approaches for REMS design, implementations, solution updates and feedback from the FDA
– Comply with regulations pertaining to standardization and evaluations
– Assess REMS efficacy with proven and progressive methods
– Increase knowledge of upcoming REMS technologies, innovation, regulatory changes that will affect your work in risk management
– Discuss the hurdles of recent FDA guidance’s impacting REMS
– Lessen the burden on stakeholders with a comprehensive understanding of their nuanced needs and stressors