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In-Person Workshop (December, 2017)
How do I Meet FDA and Get the Most Out of My FDA Meeting FDA meetings are one of the most critical aspect of any product development strategy. Despite a few guidance documents to help sponsors prepare for meetings with the FDA, it is a challenge to understand the most efficient and productive ways to prepare, conduct, and follow-up for these meetings. Sponsors struggle with understanding FDA's expectations from these meetings, and hence many sponsors fail to get the most benefit from them. Over the years, the FDA has also updated processes and practices for meeting with sponsors and added many new types of meetings. This two day seminar will provide an exhaustive training in the process of FDA meeting request, meeting packages, logistics, planning, conduct and best practices for all kinds of meetings with the FDA. Throughout the workshop, the trainer will discuss case studies from his 15 years of experience with practically all kinds of FDA meetings and provide examples to highlight the common errors and potential solutions. Templates, SOPs and checklists will be provide to assist the attendees with preparing for their next meeting with FDA. This one-of-a-kind workshop will provide step-by-step instructions and practical tips to the most productive meeting with FDA for all FDA-regulated organizations. Pre-IND meetings, EOP2 meetings, pre-submission meetings, Breakthrough meetings, Dispute resolution meetings, Biosimilar meetings, Advisory Committee meetings, Animal Rule meetings, and all other kinds of meetings will be discussed. Learning Objective:
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Background:
FDA meetings are undeniably one of the most important steps in the development of medicinal products. Whether you are developing a drug, biological product, medical device, generic, diagnostic or anything else regulated by the FDA, it is a good idea to get direct feedback from the FDA about their concerns regarding your product before embarking on expensive and time-consuming development steps. FDA meetings need to be included in all product development strategies. However, the best answers are the one obtained by asking the best questions. Not only the best questions but the conduct of the meeting, management of time, efficiency of response, careful consideration of the answers, all could lead to successful conclusion to the meeting. This workshop would discuss the what, who, when and how of the FDA meetings. Steps from requesting a meeting, preparing and submission of the information package, preparing for the meeting, the conduct of the meeting and follow-up will be discussed using real-life experience and case studies.
FDA meetings are undeniably one of the most important steps in the development of medicinal products. Whether you are developing a drug, biological product, medical device, generic, diagnostic or anything else regulated by the FDA, it is a good idea to get direct feedback from the FDA about their concerns regarding your product before embarking on expensive and time-consuming development steps. FDA meetings need to be included in all product development strategies. However, the best answers are the one obtained by asking the best questions. Not only the best questions but the conduct of the meeting, management of time, efficiency of response, careful consideration of the answers, all could lead to successful conclusion to the meeting. This workshop would discuss the what, who, when and how of the FDA meetings. Steps from requesting a meeting, preparing and submission of the information package, preparing for the meeting, the conduct of the meeting and follow-up will be discussed using real-life experience and case studies.
Who Will Benefit:
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc.)
- Project managers
- Clinical trial specialists
- Regulatory compliance associates and managers
- People investing in FDA-regulated product development projects
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com
