Current hot topics for regulatory professionals

Article from TOPRA,  Regulatory Rapporteur – Vol 9, No 11, November 2012. 

Authors

Patricia Duchêne, Director Regulatory Affairs, Celgene Corporation, US; Monique Garrett, CEO, PrismWorks, LLC; 

Sara Snow, Senior Associate II, Regulatory Development, Biogen Idec

This article represents views of senior US regulatory leaders on current hot topics for regulatory professionals.

• What is the biggest challenge you see facing the US regulatory affairs community in the coming year? 
• Are you witnessing any new trends in the regulatory affairs arena that you think will impact approval processes in the US? 
• How do you think agency/sponsor relations will change in the coming year?
• Do you have any advice for regulatory professionals who may be planning on submitting in the US?

Reference: All in a day’s work