How to Effectively Communicate with FDA Regulators

Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Thursday, October 18, 2018

This webinar will be broadcast in North America on Thursday, October 17th, 2018 | 10pm EDT / 7pm PDT

3D Communications has spent the last 15 years preparing companies for FDA pre-submission and advisory committee meetings. During this time, the company has developed their “Top 10 Rules” to help make the journey smoother and effectively hit your target. In this webinar, the speaker will discuss some of the common mistakes that sponsors make in their communications with regulators – and some time-tested rules which apply across all types of regulatory meetings.

Some of the mistakes that companies make can be as simple as going into meetings without a thorough understanding of your division or having no clear agenda. But, in order to truly communicate effectively with regulators, there are crucial steps that can be taken to avoid some of these mistakes. Whether it be preparing effectively, building a relationship with your division, or simply listening to your regulator, 3D Communications provides proven tactics that can be used to insure your communication is most effective and successful in all future meetings.

 

 

Webinar Partner – Asia Regulatory Professional Association (ARPA)

The Asia Regulatory Professional Association (ARPA) is an organization of Healthcare Regulatory Affairs professionals in Asia that aims to raise the standard and social recognition of Regulatory Professionals as part of a healthcare team.

 

 

Speaker

Virginia Cox, JD - Senior Consultant and Lead, 3D Communications

Virginia Cox, JD, is a Senior Consultant and 3D Communications lead. 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.

Message Presenter

Who Should Attend?

  • Senior level professionals working within Regulatory Affairs and Clinical Operations for pharma, medical device and biologics companies
  • Anyone preparing for interactions and regulatory meetings with FDA

Xtalks Partner

3D Communications

3D Communications prepares medical device companies for high stakes FDA interactions and panel meetings. We have provided strategic counsel and hands-on implementation for more than 250 FDA meetings and submissions including cardiovascular and neurologic devices.  Our services include messaging, scripting, Q&A, slide development, panel pack writing, and communications coaching.

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