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Regulatory Strategic Plan: Don’t Start Development Without One
Session Chair(s)
Mark Ammann, PharmD
President
Quantum Regulatory Solutions, LLC, United States
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 : Develop key elements of a regulatory strategy using hypothetical case studies and a strategy document template.
Speaker(s)
Facilitator
James Rawls, PharmD
Sumitomo Pharma America, Inc. , United States
Executive Director, Regulatory Affairs
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