RAPS Chicago Chapter: Early Preparation is Key to Successful FDA Panel Reviews

When:  Apr 5, 2016 from 17:30 to 20:30 (ET)

Save on registration when you also register to attend the 6 April event, “Shifting Risk Landscape for BioPharma and What’s Next for Pricing and Patient Access.

5 April 2016
5:30–8:30 pm
AbbVie
Abbott Park, IL

Given the Food and Drug Administration’s (FDA) increased scrutiny of clinical and long-term safety, the agency is calling for more public Advisory Committee hearings each year. Good data alone are no longer enough to win approval. In today’s environment, it is critical to prepare a clear, credible and engaging presentation and to start the preparation process early. You must ensure that your team is ready for the most difficult questions in order to sustain credibility and achieve a positive committee recommendation. Importantly, Sponsors need to understand the FDA’s guidance on panel review meetings and their implications so that they can anticipate likely panel questions well before NDA or PMA submission. In doing so, Sponsors can proactively engage with FDA early and consistently throughout the product development program. Most companies are ill-equipped to prepare for a daunting FDA Advisory Committee or Device Panel meeting. With so much at risk in a single presentation, all stakeholders must mobilize and have a clear strategy when approaching FDA for market approval. This presentation will walk you through key aspects of FDA’s guidance and provide you with proven steps that will optimize your success before an FDA Advisory Committee meeting.

Upon the presentation's conclusion, you should be able to:

  • Understand the process leading up to an Advisory Committee or Device Panel meeting, for both the Sponsor and FDA
  • Understand all the essential steps necessary to be successful at an FDA Advisory Committee meeting
  • Identify key project activities that can be strengthened by incorporation of panel considerations
  • Staff a team of internal personnel and external advisors to properly prepare for an FDA Advisory Committee meeting
  • Strategize opportunities for improving the chances of success

A light meal will be provided for all attendees and participants are eligible to claim two (2) continuing education and/or RAC recertification points.

Date/Time:
Tuesday, 5 April 2016
5:30–6:00 pm     Registration, Check-In
6:00–7:00 pm     Networking and Dinner
7:00–8:30 pm     Speaker Presentation and Q/A Session

Location:
AbbVie
100 Abbott Park Road
Building AP30LL
Conference Center Room E
Abbott Park, IL 60044

Find directions online or call +1 224 667 6100

Registration:
RAPS is offering a discounted registration fee when registering for both events. Contact RAPS customer service at +1 301 770 2920 ext. 200 to get the special rate.

Registration Fee (for one event):
RAPS Members: $40             Nonmembers: $55

Registration Fee (when registering for both events):
RAPS Members: $30             Nonmembers: $45

Speaker:
Susan Resnick, PhD, executive consultant, 3D Communications

Susan Resnick, PhD, brings more than 20 years of experience in clinical research, medical device technology, and regulatory strategy to 3D clients. Susan uses her extensive experience to guide 3D's clients through critical pre-IDE and pre-PMA meetings with FDA, as well as help them prepare for FDA advisory committee meetings. In her role as a scientific lead for 3D clients, Susan provides strategic review of clinical study reports, briefing books, and panel packs. Before joining 3D, Susan held a variety of clinical research leadership positions at Boston Scientific and Medtronic, working on teams going through the approval process. She has published more than 35 manuscripts in peer review medical journals. Susan has a Master's of Public Health and PhD in Epidemiology from the University of Minnesota.

Local Contact:
Carol Cooper, RAC, RAPS Chicago Chapter Co-Chair
Joe Orlowski, RAC, RAPS Chicago Chapter Co-Chair

RAPS Contact:
Wesley Carr, +1 301 770 2920