Given the Food and Drug Administration’s (FDA) increased scrutiny of clinical and long-term safety, the agency is calling for more public Advisory Committee and Panel hearings each year. Good data alone are no longer enough to win approval. In today’s environment, it is critical to prepare a clear, credible and engaging presentation. You must ensure that your team is ready for the most difficult questions in order to sustain credibility and achieve a positive committee recommendation. Most companies are ill-equipped to prepare for this daunting meeting. With so much at risk in a single presentation, all stakeholders must mobilize and have a clear strategy when approaching FDA for market approval. This presentation will provide you with proven steps that will optimize your success before an FDA Advisory Committee.
Speakers
Jim DiBiasi, 3D Founding Partner & Communications Lead, 3D Communications
Jim DiBiasi is known for his ability to lead diverse teams and help them succeed at decisive communications opportunities. Jim provides strategic and tactical communications counsel and coaching to top executives, scientists, and doctors at pharmaceutical, biotech, and device companies. Jim has guided scientists and executives through numerous regulatory communications, such as pre-NDA and IND meetings and challenging advisory committee meetings. He has been instrumental in developing 3D’s proprietary process and communications tools to help clients analyze their audiences and prepare for their communications in more effective ways. A gifted communicator, Jim has practical experience in front of the camera and before live audiences. He has crafted and delivered hundreds of presentations and served as a legislative lobbyist and media spokesperson for Fortune 200 companies, leading them through numerous communications crises.
Message Presenter
Christine Glenn, Head of Regulatory Excellence, Sanofi
Message PresenterWho Should Attend?
This webinar will benefit regulatory and medical affairs professionals working in the pharmaceutical, biologics and medical device industries, with relevant job titles including but not limited to:
- Chief Medical Officer
- CEO
- Vice President Regulatory
What You Will Learn
- Understand all of the essential steps necessary to be successful at an FDA Advisory Committee meeting
- Create a realistic schedule and timeline to prepare for an FDA Advisory Committee meeting
- Staff a team of internal personnel and external advisors to properly prepare for an FDA Advisory Committee meeting
Xtalks Partner
3D Communications
3D Communications prepares pharma, biotech and device companies for high stakes FDA interactions, Advisory Committee meetings, and Market Access negotiations. We have provided strategic counsel and hands-on implementation for more than 250 Advisory Committee meetings and submissions. Our services include messaging, scripting, Q&A, slide development, briefing book writing, and communications coaching.
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