Wednesday FoREMS: Long-Acting Opioid Class REMS: An Update of New Requirements and Implications for Us All

Wednesday May 11, 2011

Long-Acting Opioid Class REMS: An Update of New Requirements and Implications for Us All

Last month FDA issued requirements for the long awaited Long-Acting Opioid Class REMS programs. This webinar will focus on the components of the program and the implications and precedents for industry.

Overview:

  • Review the Long-Acting Opioids Class REMS components
  • Explore the implications for manufacturers
  • Discuss the precedents established for industry


Presenter: Jeff Fetterman, President - ParagonRx


Webinar Slide Set:

click to view:
Welcome
Agenda
White House Plan to Reduce Opioid Harms
“Epidemic: Responding to America’s Prescription Drug Abuse Crisis”
Key Elements of the Plan
FDA Opioid Statements
FDA Opioid Strategy
FDA Opioid Strategy (cont'd)
FDA Opioid Strategy (cont’d)
List of Long-Acting and Extended-Release Opioid Products Required to have an Opioid REMS: Brand
List of Long-Acting and Extended-Release Opioid Products Required to have an Opioid REMS: Generic
REMS Goal
REMS Elements: Medication Guide or PPI
21 CFR 208.24 - Distributing and Dispensing a Medication Guide
REMS Elements: Communication Plan
REMS Elements: Elements to Assure Safe Use
REMS Elements – Appendix A: Content of Education Program
REMS Elements – Appendix A: Content of Education Program
REMS Elements – Appendix A: Content of Education Program
REMS Elements – Appendix B: Patient Education
REMS Elements: Implementation Plan
REMS Elements: Timetable for Submission of Assessments
Selected Uncertainties
Precedents
Conclusions
Thank You

 

 

 

 

 

 

 

 

 

Session Replay:



 

Previous page: Webinars Next page: Video / Podcasts
 
Register for periodic industry updates: