CBI’s 3rd Annual Effective Preparation for FDA Advisory Committees

It is now more important than ever to be well prepared for FDA Advisory Committee review. CBI’s forum gives you the tools to meet this challenge.

Under the legislative authority of the Food and Drug Administration Amendments Act (FDAAA) of 2007, the Agency is required to initiate reviews of most new products, including drugs, devices, diagnostic tools and biologics, prior to approval.

Hear from industry’s clinical and regulatory leaders and the foremost experts from consulting firms and government agencies about meeting the increasing demands of Advisory Panel review, including:

• Getting to know the panel – Understand the roles of ad-hoc members, the public and the press
• Interacting with the FDA pre-meeting – How PDUFA V could streamline this process
• Responding to Panel questions regarding comparative effectiveness and price
• Demonstrating market need and value
• Preparing a post-marketing review
  

About Our Co-Sponsor: 3D Communications

3D Communications specializes in turnkey FDA meeting preparation – including FDA development meetings, regulatory submissions, advisory committee meetings, scientific communications skills training and stakeholder engagement.   We have provided strategic counsel and hands-on tactical implementation to support regulatory submissions and more than 50 advisory committee projects, involving 24 different FDA committees.   Our mantra “An FDA Meeting is the Wrong Time for An Original Thought” is codified in our 3D ACT™ preparation process.    We have developed proprietary tools and processes that support the 3D ACT™ preparation process, including:

• KOLLEAD™  - relational database of profiles on all current FDA Advisory Committee Members and more than 2500 former FDA Advisory Committee members, as well as previous FDA employees and other regulatory experts;
• ADCOM RADAR®  - a customized report on your advisory committee members and what will influence their vote, based on past practices and behavioral patterns;
• MATCH.MOCK® and MATCH.EXPERT™- a detailed report with recommendations of who you should select to participate in each of your mock advisory committee meetings and expert roundtable reviews
• ACCORD™ -  a robust document management portal specifically designed to manage and share documents while facilitating quality control;
• PinPoint™ – blazing fast and robust slide recall software; and
• Talk.Right™ – on-demand, online, interactive speaker training to enhance communications skills for all personnel.
   

These tools are explicitly designed to help teams improve interactions with the FDA and achieve a positive vote from the advisory committee.  
 
At 3D we turn preparation into a science – whether it’s for an FDA meeting, and application for approval, an advisory committee meeting or scientific meeting.   So if you are really serious about being prepared, you want us on your team.