New Training Course - Staying Current With FDA Approval Trends

Classroom course helps pharma/biotech companies avoid the costs of non-compliance

Malvern, PA - December 18, 2012 - The Center for Professional Innovation and Education (CfPIE) has introduced a new course, Recent FDA Approval Trends: What You Must Know, to help pharmaceutical and biotechnology professionals stay abreast of evolving regulatory trends. The comprehensive, two-day course will be presented on January 28-29, 2012 at the Doubletree Valley Forge in King of Prussia, Pennsylvania.

Addressed are cost-effective strategies and tactics for keeping track of developments in FDA approvals and the latest requirements in a complex regulatory environment to avoid the consequences of non-compliance. It breaks down information compiled from the Tufts Center for the Study of Drug Development (Tufts CSDD) and from consultant and government reports into perspectives for individuals working across a broad range of disciplines. This content holds particular importance for those in clinical development, translational medicine, regulatory science, regulatory affairs, risk management, clinical/regulatory informatics, statistics, strategic planning, and project management.



The curriculum covers current trends and provides insights into how they translate into the future. It also compares tactics adopted by competitors as well as trend variations within therapeutic areas and product types. Key topics include basic approval trends for NMEs, NDAs, BLAs, and Supplements; special product designations/programs; regulatory science and 'next wave' product approvals; the impact of FDA and Sponsor workload on approval trends; factors that may introduce bias into the approval process; and what PDUFA's past tells us about its future.