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3D Communications Contributes to European Regulatory Organization Publication

The November issue of the TOPRA┬áRegulatory Rapporteur features an article entitled “FDA Advisory Committee Meetings: What they are? Why do they happen? and What do they mean for regulatory professionals?”

The article provides a brief history of the significance of advisory committee meetings, details how a sponsor can best prepare for these high-stakes events, and discusses how an FDA Advisory Committee Meeting can impact a companies’ development plans.

Virginia Cox, JD, a Senior Consultant with 3D Communications, co-authored the article. Before joining 3D, Virginia was the Associate Commissioner for the Office of External Affairs at the U.S. Food and Drug Administration (FDA). Her FDA experience, along with her role as a Communications Lead on numerous 3D FDA Advisory Committee projects, uniquely qualifies her to provide important perspectives on this topic.

For the full article, click HERE.

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3D to be Exhibitor at AdvaMed 2014 MedTech Conference

October 6 – October 8, 2014

Chicago, Illinois

Register HERE

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3D to be Exhibitor at the 2014 RAPS Regulatory Convergence

September 27 – October 1, 2014

Austin, Texas

Register HERE

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RAPS Texas Chapter Meeting

July 17, 2014

5:00-8:00pm

RAPS Texas Chapter Meeting

The Steps to a Successful Advisory Committee or Device Panel Meeting

Austin, Texas

Register HERE

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Thriving Again in 2014: Preparing for Success, Not Just Survival at FDA Advisory Committee Meetings

Building on the high energy panel discussion session at the 2013 BIO International Convention, this panel returns for a current look at the dos and don’ts for managing FDA advisory committee meeting activities. Panelists will provide an in-depth look at several high-profile cases, and share their perspectives and first-hand experiences. David Schull, president at Russo Partners, will moderate this interactive, talk-show-style session that headlines Penny Daniels, strategic communications consultant at 3D Communications; Craig Audet, PhD, senior vice president, operations and head of global regulatory affairs with Arena Pharmaceuticals, Inc.; Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and former FDA associate commissioner of external affairs; and Silvia Taylor, senior vice president, investor relations, public relations, and corporate communications at Sucampo Pharmaceuticals, Inc.

BIO International Convention

San Diego, California

Tuesday, June 24th

3:00 PM – 4:00 PM

REGISTER HERE

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