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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

Back to Agendas

Keys to Managing a Successful Regulatory Strategy and Submission

Session Chair(s)

Lauren Neighbours, PhD, RAC

Sr. Director and Head, Regulatory Affairs

Istari Oncology, United States

This forum will discuss tools for implementing an effective regulatory submission strategy. A panel of experts will provide their insight on best practices for early, mid, and late-phase product development planning.

Learning Objective : Evaluate tools that can help manage a product development plan; Summarize best practices for preparing for and executing a regulatory submission.

Speaker(s)

Targeted Labeling Is the Key to Your Marketing Application Strategy

Diana E Bytnar Fordyce, PhD, MS, RAC

Consultant, Switzerland

Regulations Pharmaceuticals

Seven Recommendations for Building a Better NDA

Jeff Antos

The Weinberg Group Inc., United States

Vice President

Questions to Consider Before Assembling Your eCTD

Robert Rohde

Pharmakey LLC, United States

Head of Submissions

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Ways to register

Registration override should work.