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Regulatory Strategic Plan: Don’t Start Development Without One

Track:
Regulatory Affairs and Submissions

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
312

Room Number:
16A

Level:
Intermediate

Type:
Workshop

Title:
Regulatory Strategic Plan: Don’t Start Development Without One

Chair(s):
Mark A. Ammann, PharmD
President
Catalyst Regulatory Services, LLC, United States

Description:
This interactive, hands-on workshop will provide instruction on how to prepare a regulatory strategic plan. Participants will be divided into teams and given a template. With the help of instructors, each team will prepare key components.

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The San Diego Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this offering will not be recorded.

Learning Objective(s):
Develop key elements of a regulatory strategy using hypothetical case studies and a strategy document template.

Presentation(s) & Speaker(s):
Facilitator
James T. Rawls, PharmD
Vice President, Regulatory Affairs
Sunovion Pharmaceuticals Inc., United States