Risk Evaluation and Mitigation Strategies - Webinar By ComplianceOnline (FDA GXP Compliance -)
Venue: Online Event
|Event Date/Time: Jun 14, 2012||End Date/Time: Jun 14, 2012|
Risk Evaluation and Mitigation Strategy (REMS) continues to be a critical part of the FDAâ€™s focussed efforts to increase safety of marketed products (drug or biological). As such they are enforceable by civil monetary penalties of up to $250,000 per violation that can continue to double for subsequent 30-day periods, up to $1 million per period, $10 million per proceeding. Products in violation of REMS requirements may not (continue to) be introduced into interstate commerce.
- When are REMS required?
- What elements need to be included in the REMS?
- What format should be used for submissions?
- How far have some of these requirements been relaxed?