Situation Rooms

Engage with RAPS Fellows in thought-provoking discussions on issues critical to regulatory.

Monday, 24 October, 12:15–1:15 pm, Room 128

Your Mother was Right, Always Tell the Truth – A Discussion of Ethics in Regulatory
Experienced regulatory professionals will discuss ethical situations, ask for responses from attendees, and then agree on the best approach to each of the situations discussed.

Led By:
Joy L. Frestedt, PhD, RAC, CCTI, FRAPS, president and CEO, Frestedt Incorporated
Sue Sutton-Jones, FRAPS, vice president, regulatory affairs/quality assurance, Conmed Linvatec Corp.
O. Reed Tarwater, PhD, RAC, FRAPS, director, pharmaceutical consulting services, Anson Group



Do's and Don'ts When Dealing with FDA
Join the discussion on how to interact with FDA when requesting a meeting in writing and preliminary verbal discussions, conversations on the phone, and face to face in meetings. This discussion includes of interfacing with FDA inspectors and investigators, and emphasizes reduction of adversarial relationships.

Led By:
Robert Schiff, PhD, RAC, CQA, FRAPS, president and CEO, Schiff & Company, Inc.
Winifred C. Wu, MBA, FRAPS, president, Strategic Regulatory Partners, LLC

Monday, 24 October 2011, 12:15–1:15 pm, Room 127

The Matrix: Managing Up and Across
A strong connection between you and your boss and peers can result in professional and business success, while a poor relationship can be a career anchor. In this situation room, we will engage the audience in an open discussion of best practices, share experiences that "could have gone better," and hear tips from RAPS Fellows.

Led By:
Mark Gordon, RAC, FRAPS, vice president, global regulatory and clinical affairs, Synthes
Carolyn S. Albertson, FRAPS, senior director, global regulatory, government affairs & customs, Abbott Laboratories Inc