Risk Evaluation and Mitigation Strategies (REMS) 2010

ACI s Risk Evaluation and Mitigation Strategies (REMS) 2010: Managing product risks and complying with FDAAA safety regulations is the one event that will provide you with a comprehensive understanding of REMS regulations which will allow your company to successfully develop and implement a REMS. Since the 2007 enactment of FDAAA, the FDA has identified over 89 products that require a REMS, and it is becoming almost inevitable that at some point a manufacturer will have to develop a REMS for a product. In light of this evolving regulatory landscape, it is increasingly important for drug and biologics manufacturers to understand the new safety obligations that can be mandated by the FDA.
Learn to Comply with New REMS Regulations without Compromising the Commercial Viability of Products
While some REMS fall into the category of medication guides, others are more restrictive and impose burdensome obligations on manufacturers which have the potential to affect the profitability of a product. Beyond simply learning what the REMS regulations are, this conference also focuses on the strategies manufacturers can employ to prevent a REMS from negatively impacting a product and in some cases using REMS to maximize profit.
Our faculty of in-house professionals and outside counsel will provide you with the practical, real-world solutions you need to manage product risks in today s regulatory environment. Hearing from manufacturers who have already gone through this process or who are in the midst of the process themselves, will provide you with the examples you need to find solutions to your company s challenges.