October 8, 2014
FoREMS & More: Standardizing and Evaluating REMS: Review of Draft Report Followed by Panel Discussion with FDA Participants
12 pm New York time, 9 am California time, 5 pm London time
On Tuesday, September 23, 2014, the Food and Drug Administration (FDA) announced the availability of a draft report entitled, ‘‘Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)’’. This report describes the Agency’s findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings.
This webinar will feature an overview of the draft report followed by a panel discussion with FDA participants.
This webinar will provide:
- Background and statutory basis of the draft report
- Overview of report findings
- Description of FDA Standardization Projects
- Panel discussion with FDA participants
- Jeff Fetterman – President, ParagonRx
- Panel Participants – FDA
To view the FDA report that was discussed during this webinar, click here.
If you would like to view the recording of this webinar, click here.
To view and to download a copy of the slides presented during this webinar, click here.
To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email email@example.com