Presenting before an FDA Advisory Committee can be one of the most important—and most stressful—milestones in a product’s development. Good data alone is no longer enough to win approval. In today’s environment, companies must prepare a clear and persuasive presentation based on the data. They also must know how to answer the committee’s challenging questions in a credible and confident way. Most companies are ill-equipped to prepare for this daunting meeting alone. This webcast will provide you with proven steps used in more than 150 Advisory Committee Meetings, to prepare your team and optimize your success.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast's conclusion, you will be able to:
- Describe the essential steps necessary to be successful at an FDA Advisory Committee or Device Panel meeting
- Create a realistic schedule/timeline to prepare for an FDA Advisory Committee or Device Panel Meeting
- Staff a team of internal personnel and external advisors to properly prepare for an FDA Advisory Committee or Device Panel Meeting
Who Should Attend
- Regulatory professionals
- Clinical professionals
- Medical affairs professionals
- Communications professionals
Cindy DiBiasi, founding partner, 3D Communications
Cindy DiBiasi has built a reputation as a leading healthcare communications consultant by working with top executives at some of the world's largest companies. Her approach is rooted in the belief that even the most daunting communications challenges provide opportunities for companies and executives to define themselves and convey important information to regulatory and government officials, customers, colleagues, shareholders and the public. DiBiasi’s work ranges from helping clients identify their communications strategy and develop messages on controversial healthcare issues, to leading them through high-stakes FDA meetings and advisory committee hearings. DibIasi began her media career as a broadcast reporter in the US and Europe. She also was the medical reporter for the CBS affiliate in Washington, DC, where, as part of her responsibilities, she covered FDA.
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