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• Team Collaboration • Documentation • Data Standards • Submissions • Presentations

April 26-27, 2018
  • Washington, DC

CBI’s FDA Advisory Committee Master Class features best practices from industry thought-leaders and experienced peers to streamline the process of pharmaceutical product approval before an advisory committee. Regulatory, clinical, medical and marketing teams must develop strategies to effectively document, meet data standards at each step of drug lifecycle, track submission timeline and prepare concise presentations for FDA approval. Teams also navigate new regulatory developments and utilize emerging technologies to maximize efficiency for regulatory submission through cutting time and cost.

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

FDA approved about 88%
of NDAs or BLAs endorsed
by advisory committees!

(McKinsey Center for Government, October 2013)

Download the Conference Preview

FDA Advisory Committee Master Class

• Team Collaboration • Documentation • Data Standards • Submissions • Presentations

CBI’s FDA Advisory Committee Master Class features best practices from industry thought-leaders and experienced peers to streamline the process of pharmaceutical product approval before an advisory committee. Regulatory, clinical, medical and marketing teams must develop strategies to effectively document, meet data standards at each step of drug lifecycle, track submission timeline and prepare concise presentations for FDA approval. Teams also navigate new regulatory developments and utilize emerging technologies to maximize efficiency for regulatory submission through cutting time and cost.

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

FDA approved about 88%
of NDAs or BLAs endorsed
by advisory committees!

(McKinsey Center for Government, October 2013)

Download the Conference Preview