RAPS Indiana Chapter: Practices and Preferences of CDRH Advisory Committee Members - Know Your Audie

When:  Jun 16, 2016 from 17:30 to 20:30 (ET)
Associated with  Indiana Chapter

16 June 2016
6:00–8:30 pm
The Rathskeller Restaurant
Indianapolis, IN

Join your regulatory colleagues from across the Indianapolis area for an evening of networking and an expert presentation entitled, “Practices and Preferences of CDRH Advisory Committee Members - Know Your Audience!.” This meeting is sponsored by the RAPS Indiana Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals.

For many premarket approval (PMA) submissions and supplements, a medical device advisory committee panel meeting is a required step towards FDA product approval. In order to prepare appropriately for this critical meeting, it is important for sponsors to understand how panel members prepare for the meeting and what factors influence their votes.

This presentation will provide you with survey results of 3D Communications’ recent survey of CDRH advisory committee members. Data will be presented on topics such as how members prepare for advisory committee meetings, what their preferences are for the sponsor’s panel pack and presentation, and what influences their voting decisions.

Learning Objectives:

  • Understand the practices and preferences of advisory committee members
  • Understand how panel members view the sponsor’s presentation, Q&A, and panel pack
  • Understand how the open public forum influences panel members
  • Know what materials have the most impact on how a panel member votes

Refreshments will be available to all meeting participants and attendees may claim two recertification points.

Date/Time:
Thursday, 16 June 2016
5:30–6:00 pm     Registration Check-In
6:00–7:00 pm     Networking and Refreshments
7:00–8:30 pm     Speaker Presentation and Q&A Session

Location:
The Rathskeller
401 East Michigan Street
Indianapolis, IN 46204

Directions are available online or by calling +1 317 636 0396

Registration:
Prior to 10 June:
RAPS Members: $25 Nonmembers: $35

On or after 10 June:
RAPS Members: $35 Nonmembers: $45

» Registration Form (PDF) for registration by mail or fax.

You can also register by calling +1 301 770 2920 ext. 200

Speaker:
Susan Resnick, PhD, executive consultant, 3D Communications brings more than 20 years of experience in clinical research, medical device technology and regulatory strategy to 3D clients. Resnick 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, Resnick provides strategic review of clinical study reports, briefing books and panel packs. Before joining 3D, Resnick 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. Resnick has a master's of Public Health and PhD in Epidemiology from the University of Minnesota.

Local Contact:
Gretchen Bowker, RAC, FRAPS, chair, RAPS Indiana Chapter

RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations, RAPS