September 14, 2011
Wednesday FoREMS: Anticipating Change: Review of CDER’s Science and Research Needs Report Wednesday FoREMS: Anticipating Change: Review of CDER’s Science and Research Needs Report
Anticipating Change: Review of CDER’s Science and Research Needs Report
Individuals responsible for risk management programs at pharmaceutical companies attempt to anticipate the needs and interests of FDA as they design, operate, and assess the performance of REMS programs. Anticipating these trends is essential because apparent regulatory standards have advanced even during the relatively short time since the draft guidance was published in 2009. In July 2011, FDA published a report, Identifying CDER’s Science and Research Needs Report, that includes considerations for improving risk assessment and management strategies to reinforce the safe use of drugs. Although this is not regulatory guidance, we believe it does offer pharmaceutical professionals involved with risk management insight into trends and future expectations that may influence standards for risk management. This will be the topic of this month's Wednesday FoREMS webinar.
- Review risk management related sections of the July 2011 FDA publication, Identifying CDER’s Science and Research Needs Report
- Identify specific science and research needs that suggest future trends for risk management
- Discuss possible implications for pharmaceutical professionals involved with risk management of their products
- Jeff Fetterman, President - ParagonRx
- Caitlin Fontes, MPH, Clinical Services Manager - ParagonRx
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