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Team Collaboration • Documentation • Data Standards • Submissions • Presentations

April 26-27, 2018
  • Washington, DC

The FDA has a well-defined process for obtaining expert input from its advisory committees and incorporating the input into its product review process. These meetings are high-stake interactions, since many manufacturers spend many years and millions of dollars preparing for the launch of a new product.
The FDA’s approval decisions have been broadly consistent with the recommendations of its advisory committees, which is why CBI has dedicated a master class to assist manufacturers in their preparation for this meeting.

CBI’s FDA Advisory Committee Master Class features the best practices from industry experts, and draws upon successful examples, to streamline the entire product approval process to assist regulatory and clinical teams in developing the following strategies: meeting data standards, providing effective documentation, tracking submission timelines and preparing concise presentations for FDA approval.

Can’t Miss Content for 2018 —
Case Studies and Panels Covering:

  • FDA and FDA Advisory Committee Regulatory Updates
  • Meeting Data Standards in the Drug Lifecycle to
    Simplify FDA Review Process
  • Advisory Committee Preparation 101 Series —
      Part 1: Effectively Tracking Timeline
      Part 2: Establishing a Strong Team
  • Develop Best Practices in Complex Regulatory
    Documentation and Writing for Regulatory Submissions
  • Effective Strategies for Clear and Concise Presentations
  • Team Collaboration with Clinical, Regulatory,
    Medical and Marketing Teams

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